The objectives of this study are to evaluate the efficacy and safety of crofelemer treatment in adults affected by Short Bowel Syndrome (SBS) with an ileostomy on parenteral support (PS) in reducing output or PS needs. Crofelemer will be provided as a powder three times daily for 12 weeks and a 4 week follow up. .

Start Date15 Feb 2025

Sponsor / Collaborator

The Cleveland Clinic Foundation

[+1]

NCT06721871

/ Not yet recruitingPhase 2

Evaluation of Safety, Tolerability and Efficacy of Crofelemer Following Multiple Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Participants With Microvillus Inclusion Disease (MVID)

a 32-week study that will evaluate the safety, tolerability and preliminary efficacy of multiple ascending doses of crofelemer, compared to placebo, using a randomized cross-over design within each dose level, when administered to participants with MVID receiving parenteral support (PS, defined as TPN with or without supplementary IV fluid requirements). Blinded study drug will be administered as a novel crofelemer formulation, Crofelemer Powder for Oral Solution, or a matching placebo powder formulation for oral solution. Assigned study drug will be reconstituted and administered orally (or enterally) three times daily (TID) as a concentrated liquid formulation in each of the three dose levels

Start Date01 Jan 2025

Sponsor / Collaborator

Napo Pharmaceuticals, Inc.

NCT04538625

/ CompletedPhase 3

A Phase 3 Multicenter, Randomized, Double-blind Placebo-controlled Trial Evaluating Crofelemer for the Prophylaxis of Diarrhea in Adult Patients With Solid Tumors Receiving Targeted-cancer Therapies With or Without Standard Chemotherapy

A 24-week, (two 12-week stages), randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors treated with targeted cancer therapy-containing treatment regimens. Diarrhea grading will be done according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Patients will be randomized 1:1 to placebo or crofelemer and will be stratified by the type of targeted cancer therapy and the tumor type. Placebo and/or crofelemer will be dispensed at Visit 1/Day 1 with the concurrent start of the targeted cancer therapy regimen. The initial Stage I double-blind placebo-controlled primary treatment phase will occur over a 12-week period to accommodate approximately 3 cycle chemotherapy cancer treatment dosing-cycles. The Primary and Secondary Endpoints will be analyzed after the last patient last visit (LPLV) of Stage I.
After completing the Stage I double-blind, placebo-controlled primary treatment phase, the subjects will have the option to remain on their assigned treatment arm and reconsented to enter into the Stage II extension phase. Reconsent will be required to enter into Stage II. For subjects who do not reconsent, visit 5 will be the last study visit.

Start Date07 Oct 2020

Sponsor / Collaborator

Napo Pharmaceuticals, Inc.

100 Clinical Results associated with Crofelemer

100 Translational Medicine associated with Crofelemer

100 Patents (Medical) associated with Crofelemer

Literatures (Medical) associated with Crofelemer

01 Dec 2024·CARBOHYDRATE POLYMERS

Crocin-1 laden thermosensitive chitosan-based hydrogel with smart anti-inflammatory performance for severe full-thickness burn wound therapeutics

Article

Author: Chi, Jinhua ; Chen, Ya ; Han, Baoqin ; Li, Hui ; Lv, Xiansen ; Wang, Shuo ; Yang, Yan ; Wang, Yanting ; Jiang, Zhiwen

Burns are the fourth most common type of civilian trauma worldwide, and the management of severe irregular scald wounds remains a significant challenge. Herein, crocin-1 laden hydroxybutyl chitosan (CRO-HBC) thermosensitive hydrogel with smart anti-inflammatory performance was developed for accelerating full-thickness burn healing. The injectable and shape adaptability of the CRO-HBC gel make it a promising candidate for effectively filling scald wounds with irregular shapes, while simultaneously providing protection against external pathogens. The CRO-HBC gel network formed by hydrophobic interactions exhibited an initial burst release of crocin-1, followed by a gradual and sustained release over time. The excessive release of ROS and pro-inflammatory cytokines should be effectively regulated in the early stage of wound healing. The controlled release of crocin-1 from the CRO-HBC gel adequately addresses this requirement for wound healing. The CRO-HBC hydrogel also exhibited an excellent biocompatibility, an appropriate biodegradability, keratinocyte migration facilitation properties, and a reactive oxygen species scavenging capability. The composite CRO-HBC hydrogel intelligently mitigated inflammatory responses, promoted angiogenesis, and exhibited a commendable efficacy for tissue regeneration in a full-thickness scalding model. Overall, this innovative temperature-sensitive CRO-HBC injectable hydrogel dressing with smart anti-inflammatory performance has enormous potential for managing severe scald wounds.

01 Apr 2024·American journal of medical genetics. Part A

Clinical course and therapeutic trial for a case of congenital secretory diarrhea due to novel GUCY2C variant

Author: Horton, Darlene ; Teng, Ru-Jeng ; Wong, Ian Guo Yi ; Scott, William ; Muriello, Michael ; Cramer, Jesse ; Basel, Donald ; Elkadri, Abdul

Abstract:

Chronic diarrhea presents a significant challenge for managing nutritional and electrolyte deficiencies, especially in children, given the higher stakes of impacting growth and developmental consequence. Congenital secretory diarrhea (CSD) compounds this further, particularly in the case of the activating variants of the guanylate‐cyclase 2C (GUCY2C) gene. GUCY2C encodes for the guanylate‐cyclase 2C (GC‐C) receptor that activates the downstream cystic fibrosis transmembrane receptor (CFTR) that primarily drives the severity of diarrhea with an unclear extent of influence on other intestinal channels. Thus far, management for CSD primarily consists of mitigating nutritional, electrolyte, and volume deficiencies with no known pathophysiology‐driven treatments. For activating variants of GUCY2C, experimental compounds have shown efficacy in vitro for direct inhibition of GC‐C but are not currently available for clinical use. However, Crofelemer, a CFTR inhibitory modulator with negligible systemic absorption, can theoretically help to treat this type of CSD. Herein, we describe and characterize the clinical course of a premature male infant with a de novo missense variant of GUCY2C not previously reported and highly consistent with CSD. With multi‐disciplinary family‐directed decision‐making, a treatment for CSD was evaluated for the first time to our knowledge with Crofelemer.

16 Oct 2023·The Journal of clinical investigation

Patient-derived enteroids provide a platform for the development of therapeutic approaches in microvillus inclusion disease.

Article

Author: Kalashyan, Meri ; Thiagarajah, Jay R ; Bayer, Marie-Theres ; Roland, Joseph T ; Shub, Mitchell D ; Oller, Haley ; Kolobova, Elena ; Goldsmith, Jeffrey D ; Raghunathan, Krishnan ; Jimenez, Lissette ; Hagen, Susan J ; Kaji, Izumi ; Goldenring, James R

Microvillus inclusion disease (MVID), caused by loss-of-function mutations in the motor protein myosin Vb (MYO5B), is a severe infantile disease characterized by diarrhea, malabsorption, and acid/base instability, requiring intensive parenteral support for nutritional and fluid management. Human patient-derived enteroids represent a model for investigation of monogenic epithelial disorders but are a rare resource from MVID patients. We developed human enteroids with different loss-of function MYO5B variants and showed that they recapitulated the structural changes found in native MVID enterocytes. Multiplex immunofluorescence imaging of patient duodenal tissues revealed patient-specific changes in localization of brush border transporters. Functional analysis of electrolyte transport revealed profound loss of Na+/H+ exchange (NHE) activity in MVID patient enteroids with near-normal chloride secretion. The chloride channel-blocking antidiarrheal drug crofelemer dose-dependently inhibited agonist-mediated fluid secretion. MVID enteroids exhibited altered differentiation and maturation versus healthy enteroids. γ-Secretase inhibition with DAPT recovered apical brush border structure and functional Na+/H+ exchange activity in MVID enteroids. Transcriptomic analysis revealed potential pathways involved in the rescue of MVID cells including serum/glucocorticoid-regulated kinase 2 (SGK2) and NHE regulatory factor 3 (NHERF3). These results demonstrate the utility of patient-derived enteroids for developing therapeutic approaches to MVID.

239

News (Medical) associated with Crofelemer

22 Jan 2025

·jaguarhealth.gcs-web.com

Jaguar Health Announces First Patient Dosed in Investigator-Initiated Trial (IIT) Evaluating Crofelemer for the Rare Disease Indication of Microvillus Inclusion Disease (MVID), with Proof-of-Concept (POC) Data Potentially Available H1 2025

Trial taking place at Sheikh Khalifa Medical City, a flagship tertiary hospital in the United Arab Emirates POC data generated from this study could potentially lead to reimbursed early patient access in certain European countries for crofelemer for MVID Crofelemer, Jaguar's novel plant-based prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for both MVID and short bowel syndrome with intestinal failure (SBS-IF) SAN FRANCISCO, CA / ACCESS Newswire / January 22, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics today announced that the first patient has been dosed in the independent investigator-initiated POC trial of crofelemer, Jaguar's novel plant-based anti-diarrheal prescription drug, for the rare disease indication of MVID in pediatric patients. POC data generated from this study potentially in the first half of 2025 could lead to reimbursed early patient access to crofelemer for this indication in certain European countries. The trial will also include pediatric patients with SBS-IF. It is being conducted by Dr. Mohamad Miqdady, a recognized leader in pediatric gastroenterology who is the Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division at Sheikh Khalifa Medical City (SKMC), a flagship tertiary hospital in the UAE and the largest teaching medical center in Abu Dhabi . "Dosing of the first patient in this unblinded study is an important milestone in clinical development efforts for crofelemer for MVID and SBS-IF - both of which are rare and severe diseases requiring intensive parenteral nutrition and support," said Lisa Conte , Jaguar's founder, president, and CEO. The trial is taking place at SKMC. Autosomal recessive disorders and congenital anomalies such as MVID are more prevalent in the Middle East and North Africa (MENA) region. "This study is one of five clinical efforts in rare diseases - three POC IIT studies and two Phase 2 studies - for crofelemer for the orphan disease indications of MVID and/or SBS-IF in the United States , European Union , and/or MENA regions," Conte said. "The Company's Phase 2 study to evaluate the efficacy of crofelemer for MVID in pediatric patients has been initiated, as has the independent IIT in the U.S. to evaluate crofelemer for SBS-IF in adults. The two additional studies are expected to initiate in early Q1 2025, with the availability of the first POC IIT result potentially in H1 2025, and with additional POC IIT results expected throughout 2025. In accordance with the guidelines of specific EU countries, published data from clinical investigations in MVID and SBS-IF could support reimbursed early patient access to crofelemer for these debilitating conditions." MVID and SBS-IF, rare and severe diseases requiring intensive parenteral nutrition and support, have severe morbidity and mortality implications and impact the quality of life of both patients and their caregivers. MVID is a pediatric disease with an estimated prevalence of a couple of hundred patients globally. It is characterized by severe diarrhea and malabsorption, requiring intensive parenteral support for nutritional and fluid management. Each MVID patient is a unique patient; their journey requires very careful management of their nutritional needs, and there are currently no approved drug treatments for MVID. SBS affects approximately 10,000 to 20,000 people in the U.S. , according to the Crohn's & Colitis Foundation , and it is estimated that the population of SBS patients in Europe is approximately the same size. Pediatric SBS is a malabsorptive condition caused by surgical intestinal resection due to congenital abnormalities, vascular insufficiency or severe inflammatory intestinal disease. The incidence of pediatric SBS varies between 0.02% to 1.2% of live births.1 Based on an estimate of 3.6 million live births in the U.S. in 2023,2 the maximal incidence of pediatric SBS is estimated to be approximately 43,000. Pediatric SBS-IF is associated with significant morbidity and mortality; and high medical expenses, and the patients also have severe chronic diarrhea. The associated sequelae from chronic diarrhea include significant dehydration, metabolic acidosis or alkalosis, and malnutrition. Crofelemer has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for MVID and SBS . Dr. Miqdady is an Adjunct Professor at Khalifa University's medical school in Abu Dhabi , and serves as a member of Napo's Scientific Advisory Board . He completed his Fellowship in Pediatric Gastroenterology at Baylor College of Medicine and Texas Children's Hospital in Houston . About Crofelemer Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health , visit https://jaguar.health Napo Pharmaceuticals , visit www.napopharma.comNapo Therapeutics, visit napotherapeutics.comMagdalena Biosciences, visit magdalenabiosciences.com Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that another IIT and another Phase 2 study of crofelemer will initiate in early Q1 2025, Jaguar's expectation that POC data from the MVID IIT in Abu Dhabi may be available in H1 2025, Jaguar's expectation that additional POC IIT results for crofelemer may be available throughout 2025, and Jaguar's expectation that, in accordance with the guidelines of specific EU countries, published data from clinical investigations could support early patient access to crofelemer for SBS-IF or MVID in these countries. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. 1 Beth A. Carter , MD, et al. Outcomes from a 12-Week, Open-Label, Multicenter Clinical Trial of Teduglutide in Pediatric Short Bowel Syndrome. The Journal of Pediatrics , 2017; 181:102-112 https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/books/NBK607756/ Contact: hello@jaguar.healthJaguar-JAGX SOURCE: Jaguar Health, Inc.

Orphan DrugPhase 2Drug Approval

07 Jan 2025

·www.accesswire.com

Magdalena Biosciences, a Joint Venture Between Jaguar Health and Filament Health, to Present January 12 at the Annual Neuroscience Innovation Forum

Magdalena aiming to submit Investigational New Drug (IND) application in early 2025 to the FDA for a next-generation psychoactive prescription drug candidate for potential mental health indications such as ADHD and schizophrenia, with 1-2 additional IND applications filed in 2025 SAN FRANCISCO, CA / ACCESSWIRE / January 7, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that Dr. Karen Brunke, Jaguar\'s EVP of Corporate and Business Development and Acting CEO of Magdalena Biosciences, Inc. (Magdalena), the joint venture formed by Jaguar and Filament Health Corp. (OTCQB:FLHLF)(CBOE CA:FH) (FSE:7QS) to develop novel, natural prescription medicines derived from plants for mental health indications, is presenting in person on Sunday, January 12, 2025 at the Annual Neuroscience Innovation Forum in San Francisco, CA.\"I very much look forward to providing an overview of Magdalena at this conference and meeting with potential partners and investors at this event,\" Dr. Brunke said. \"We expect Magdalena\'s lead botanical drug candidate, MB2500, to soon be IND-enabled and ready to enter the clinic for one of its first indications: executive dysfunction in attention deficit hyperactivity disorder (ADHD) and/or cognitive deficit in schizophrenia. MB2500 may have the potential to serve as a first-ever treatment for the cognitive deficit that goes untreated in schizophrenia, which is a huge unmet medical need. Schizophrenia is a disease of cognitive deficit, a deficit which appears as much as a decade before onset of psychotic symptoms,1 but no approved drug currently exists to treat cognitive deficit in schizophrenia patients.\"\"Our approach is paradigm-shifting in drug development as we expect to go from plant extract to proof-of-concept (POC) human studies in 12-24 months - a huge time and cost savings which also, based on the history of human medicinal use of the plants, has a higher probability of success,\" said Dr. Brunke.MB2500 is derived from a well characterized plant that has been in use by local populations for centuries, has been shown to have both neuroprotective and cognitive enhancing properties, but has never been put through the rigorous clinical testing required for FDA approval. One or two more additional Magdalena botanical drug candidates for mental health indications are planned to be IND-enabled in 2025.ADHD, a $25 billion global market,2 is a neurodevelopmental disorder characterized by the core symptoms of hyperactivity, inattentiveness, and impulsivity, and there is a growing need for safer ADHD treatments. Schizophrenia is a chronic, disabling mental illness that affects approximately one percent of the U.S. population.3 The global schizophrenia market is projected to grow to $13.41 billion by 2032, according to a market research report by Market Research Future.4The mission of Magdalena, which is currently approximately 40-percent owned by Jaguar, is to develop novel, safe, efficacious next-generation psychoactive FDA-approved plant-based drugs under FDA Botanical Guidance for mental health indications including schizophrenia, anxiety, depression, and ADHD. Botanical drug candidates have a long history of use by traditional psychiatrists and may have the potential to serve as a new class of plant-based psychoactive drugs which are safe for daily dosing.About Botanicals DrugsBotanicals drugs are defined by the U.S. Food and Drug Administration (FDA) as \"products from plant materials, algae, macroscopic fungi, and combinations thereof.\" Many botanical drugs have a long history of safe use in traditional medicines, which may be documented and reviewed in scientific literature. Existing scientific literature on safety may accelerate the safety review process for a botanical drug, reducing the scope and financial burden for extensive safety studies. The FDA has established guidance on botanical drug development and recognizes the complexity of botanical drugs. Additionally, botanical drugs, by virtue of their complexity, have the added benefit of being difficult to genericize. Hence there are often multiple opportunities for creating ‘trade-secrets,\' as well as novel patents around a botanical drug substance, its processing, its formulation, and so forth.The Growing Market for Medicines Derived from Psychoactive PlantsAccording to the World Health Organization, one in four people in the world will be affected by mental or neurological disorders at some point in their lives. Around 450 million people currently suffer from such conditions, placing mental disorders among the leading causes of ill-health and disability worldwide. Among children, ADHD is the most common psychiatric disorder, disrupting learning and social behaviors. Common mental health conditions include depression, PTSD, anxiety, addiction, bipolar disorder (formerly called manic-depressive illness or manic depression), and anorexia nervosa, and expand to include neuro-degenerative diseases such as Parkinson\'s, Alzheimer\'s disease, and ALS (amyotrophic lateral sclerosis), among others. Substance use disorders occur when the recurring use of alcohol and/or drugs causes clinically significant impairment, including health problems, disability, and failure to meet major responsibilities at work, home, or school. The Lancet Commission, a group of experts in neuroscience, psychiatry, public health, and related fields, estimates that the cost of mental disorders, currently on the rise in every country, will reach $16 trillion by 2030, including costs associated with lost productivity.About Filament Health (OTCQB:FLHLF) (CBOE CA:FH) (FSE:7QS)Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament\'s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines. We are paving the way with what we believe to be the first-ever natural psychedelic drug candidates.Learn more at www.filament.health and on Twitter, Instagram and LinkedIn.About the Jaguar Health Family of CompaniesJaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo\'s crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar\'s Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit www.napopharma.comNapo Therapeutics, visit napotherapeutics.comMagdalena Biosciences, visit magdalenabiosciences.comVisit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & InstagramForward-Looking StatementsCertain statements in this press release constitute \"forward-looking statements.\" These include statements regarding the expectation that Magdalena management will present the 2025 Annual Neuroscience Innovation Forum, the expectation that MB2500 will soon be IND-enabled and ready to enter the clinic for the first of two indications, the expectation that MB2500 may have the potential to serve as a first-ever treatment for the cognitive deficit that goes untreated in schizophrenia, the expectation that Magdalena may submit an IND application in early 2025 to the FDA for a next-generation psychoactive prescription drug candidate for potential mental health indications such as ADHD and schizophrenia, the expectation that 1-2 more additional Magdalena botanical drug candidates for mental health indications may be IND-enabled in 2025 and submitted as IND applications in 2025, the expectation that MB2500 may have the potential to be an effective treatment for ADHD or the cognitive deficit in schizophrenia, the expectation that botanical drug candidates may have the potential to serve as a new class of plant-based psychoactive drugs which are safe for daily at-home dosing, Magdalena\'s expectation that Magdalena may be able to go from plant extract to POC human studies within 12-24 months, and the expectation that human studies of Magdalena botanical drug candidates may have a higher probability of success based on the history of human medicinal use of the Magdalena botanical drug candidates. In some cases, you can identify forward-looking statements by terms such as \"may,\" \"will,\" \"should,\" \"expect,\" \"plan,\" \"aim,\" \"anticipate,\" \"could,\" \"intend,\" \"target,\" \"project,\" \"contemplate,\" \"believe,\" \"estimate,\" \"predict,\" \"potential\" or \"continue\" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar\'s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.1 JAMA Psychiatry. 2013;70(10):1107-1112. doi:10.1001/jamapsychiatry.2013.1552 https://finance.yahoo.com/news/attention-deficit-hyperactivity-disorder-adhd-220000543.html3 Bromet EJ, Dew MA, Eaton W. Epidemiology of psychosis with special reference to schizophrenia. In: Tsuang MT, Tohen M, Zahner GEP, eds. Textbook in psychiatric epidemiology. New York: John Wiley, 1996:283-3004https://www.marketresearchfuture.com/reports/schizophrenia-market-1625Source: Jaguar Health, Inc.Contact Info:[email protected]Jaguar-JAGXSOURCE: Jaguar Health, Inc.

Drug Approval

19 Dec 2024

·www.accesswire.com

Jaguar Health Announces Import of Coca Leaf From Peru by Joint Venture Magdalena Biosciences for Research in Treating Mental Health Indications

Magdalena to explore coca leaf's possible therapeutic benefit for treatment of potentially ADHD or other neuropsychiatric indicationsThe import was conducted in collaboration with the government of PeruSteven King, Ph.D. of Jaguar to speak about the potential promise of coca-based Botanical Drugs at the February 2025 Wisdom of the Leaf Coca Summit in PeruMagdalena is focused on developing novel, natural prescription medicines derived from plants for mental health indications SAN FRANCISCO, CA / ACCESSWIRE / December 19, 2024 / Jaguar Health, Inc.(NASDAQ:JAGX) ("Jaguar") today announced that Magdalena Biosciences, Inc. ("Magdalena"), a joint venture formed by Jaguar and Filament Health Corp. (OTCQB:FLHLF)(Cboe CA:FH)(FSE:7QS) ("Filament" or "Filament Health"), successfully completed an import of six kilograms of coca leaf from Peru to Filament's Metro Vancouver research and development facility. This is the second import of coca leaf into Canada that Magdalena has completed. It was authorized by the Peruvian Health Authority, Dirección General de Medicamentos Insumos y Drogas (DIGEMID), and acquired from the Empresa Nacional de la Coca (ENACO), the only company in Peru authorized to distribute coca leaf.Image of coca leaves. © Steven King, Ph.D."We are pleased to partner with Filament Health and Magdalena to facilitate this second import of coca leaf," said Silveria Dongo Gonzales, Technical Director of ENACO. "We appreciate Filament and Magdalena's diligent efforts in maintaining a productive relationship with ENACO.""We are delighted to be continuing our collaboration and partnership with ENACO and the people who hold the coca leaf sacred as part of their daily lives in the Andean region of Peru," said Steven King, Ph.D., Jaguar's Chief Sustainable Supply and Ethnobotanical Research Officer and an Advisor to Magdalena. "We believe that the development of Botanical Drugs from ‘whole extract' coca leaf can provide therapeutic benefit, and that the development process will benefit the people of Peru, who have been sustainably producing coca leaves for several thousand years."Dr. King will be presenting more details about the potential promise of whole extract coca leaf Botanical Drugs at The McKenna Academy of Natural Philosophy's groundbreaking Wisdom of the Leaf Coca Summit, which takes place February 3-7, 2025 in Peru.Magdalena's mission is to develop novel, safe, efficacious next-generation psychoactive FDA-approved plant-based drugs under FDA Botanical Guidance for mental health indications including schizophrenia, anxiety, depression, and cognitive deficits in attention-deficit/hyperactivity disorder (ADHD). The coca leaf imported from Peru will be used for the development of a Botanical Drug candidate for the treatment of potentially ADHD or other neuropsychiatric indications."By importing this significant volume of raw material, we are able to begin the important work of exploring coca leaf's therapeutic potential for the treatment of ADHD," said Benjamin Lightburn, Chief Executive Officer of Filament Health and Magdalena Board Member. "This import was a significant regulatory achievement by our team and we are grateful to the Peruvian government for its ongoing partnership.""We look forward to Magdalena continuing its pioneering research into the potential medicinal benefits of coca," said Dr. King. "Many commonly used neuropsychiatric prescription medications have side effects such as personality changes or sedation. With centuries of use by Indigenous healers and traditional psychiatrists, plant-derived medicines offer potential new mechanisms of action for treating mental disorders while being potentially safer than the small molecule drugs that may have ‘off target' effects.""Plant-based drugs offer new opportunities and new mechanisms of action, as highlighted in an article in The New York Times on December 16, 2024 titled "Seeking Relief From Brain Injury, Some Veterans Turn to Psychedelics," which focuses on ibogaine, an alkaloid derived from the bark of the iboga tree," said Dr. Karen Brunke, Jaguar's EVP of Corporate and Business Development and Acting CEO of Magdalena.ABOUT MAGDALENA BIOSCIENCESJaguar Health, Inc. and Filament Health Corp. formed Magdalena Biosciences, Inc. as a joint venture in 2023 to develop novel, natural prescription medicines derived from plants for mental health indications including attention-deficit/hyperactivity disorder (ADHD), depression and anxiety in adults. Boulder, Colorado-based One Small Planet, founded by Will Peterffy, has committed to funding of US$1,000,000. The goal of the collaboration is to extend the botanical drug development capabilities of Jaguar and Filament in order to develop pharmaceutical-grade, standardized drug candidates for mental health disorders.ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (CBOE:FH) (FSE:7QS)Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines. We are paving the way with what we believe to be the first-ever natural psychedelic drug candidates.Learn more at www.filament.health and on Twitter, Instagram and LinkedIn.ABOUT THE JAGUAR HEALTH FAMILY OF COMPANIESJaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit www.napopharma.comNapo Therapeutics, visit napotherapeutics.comMagdalena Biosciences, visit magdalenabiosciences.comVisit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & InstagramForward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that the coca leaf imported from Peru will be used for development of a Botanical Drug candidate for the treatment of potentially ADHD or other neuropsychiatric indications, Jaguar's expectation that the development of Botanical Drugs from ‘whole extract' coca leaf can provide therapeutic benefit and that the development process will benefit the people of Peru, and Jaguar's expectation that Dr. King will present at the 2025 Wisdom of the Leaf Coca Summit. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact Info:[email protected]Jaguar-JAGXSOURCE: Jaguar Health, Inc.Related Documents:

Drug ApprovalAcquisition

100 Deals associated with Crofelemer

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KEGG	Wiki	ATC	Drug Bank
D03605	Crofelemer	A07XA06	DB04941

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diarrhea	US	Napo Pharmaceuticals, Inc.	31 Dec 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Enteropathy	Phase 3	US	Bausch Health Americas, Inc.	01 Oct 2007
HIV Enteropathy	Phase 3	PR	Bausch Health Americas, Inc.	01 Oct 2007
Acquired Immunodeficiency Syndrome	Phase 3	US	Shaman Pharmaceuticals, Inc.	31 Aug 2001
Acquired Immunodeficiency Syndrome	Phase 3	PR	Shaman Pharmaceuticals, Inc.	31 Aug 2001
Microvillus Inclusion Disease	Phase 2	US	Napo Pharmaceuticals, Inc.	01 Jan 2025
Microvillus Inclusion Disease	Phase 2	IT	Napo Pharmaceuticals, Inc.	01 Jan 2025
Microvillus Inclusion Disease	Phase 2	AE	Napo Pharmaceuticals, Inc.	01 Jan 2025
Irritable bowel syndrome with diarrhea	Phase 2	US	Bausch Health Americas, Inc.	01 Dec 2004
Short Bowel Syndrome	Phase 1	US	Napo Pharmaceuticals, Inc.	15 Feb 2025
Acute diarrhea	Phase 1	US	Napo Pharmaceuticals, Inc.	30 Jan 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04538625 (OnTarget, Company_Website) Manual	Phase 3	Diarrhea	287	Crofelemer	fzeoanihnq(hzcankdyzb) = viptmglsgx lpeqldqdmb (mvsortjfio )	Positive	12 Dec 2024
				Placebo	fzeoanihnq(hzcankdyzb) = frdbaipvxk lpeqldqdmb (mvsortjfio )
NCT04486326 (Company_Website) Manual	Phase 4	Diarrhea	-	Crofelemer	losblwocfj(oftpskzefl) = statistically meaningful reduction svqehriziu (tqwoybkkll )	Positive	28 May 2024
				Placebo
NCT02910219 (Pubmed) Manual	Phase 2	HER2 Positive Breast Cancer HER2 Positive	51	crofelemer	hhprbswlvz(efhbekbzne) = xwelypopoz bncildkfbz (ssixfxgtex ) View more	Negative	25 Oct 2022
				no scheduled prophylactic medication	hhprbswlvz(efhbekbzne) = tnrifepvva bncildkfbz (ssixfxgtex ) View more
NCT02910219 (HALT-D, CTgov)	Phase 2	Diarrhea	53	Crofelemer (Crofelemer)	vqgarseafy(cuqscxzjkv) = hebijyicli zxyhnqazzd (nmbmkpueme, ejehvaadkr - xastiafikk) View more	-	24 Oct 2022
				THP+TCHP (Control)	vqgarseafy(cuqscxzjkv) = sadnivgyjd zxyhnqazzd (nmbmkpueme, ikqmxkmtnk - uuzauuztpq) View more
NCT02910219 (Halt-d, SABCS2022)	Phase 2	Neoadjuvant \| Adjuvant HER2+	53	Crofelemer	mgcqdisrrl(jdsoujeuci) = oawtjxjsmi dxddbmhagk (ahchdznywx ) View more	Positive	15 Feb 2022
				Control	mgcqdisrrl(jdsoujeuci) = aoumgempwr dxddbmhagk (ahchdznywx ) View more
NCT02910219 (HALT-D, Company_Website) Manual	Phase 2	Diarrhea	51	Crofelemer	opytlizkbu(pditydqfwy) = not statistically different for the two groups ipwtvcfntq (ythvgvrsdi )	Negative	10 Dec 2021
				standard of care
NCT00547898 (ADVENT, CTgov)	Phase 3	HIV Enteropathy	374	Placebo (Placebo)	amftukdgxq(urummylsol) = qxsvkbpepl lfoizxmxvx (cnfsdvrxhy, pyhlnbgeyb - nxayrdooav) View more	-	03 Sep 2020
				Crofelemer 125 mg (Crofelemer 125 mg)	amftukdgxq(urummylsol) = bryxggvgoo lfoizxmxvx (cnfsdvrxhy, rkjvmrnzmp - lhmkwvcahu) View more
NCT01374490 (CTgov)	Phase 3	Diarrhea \| HIV Enteropathy	250	Crofelemer	tbpdnhcdoo(wqwywuqeul) = flvwgamota gwfjuhuzgv (ymhqdjplen, vcurvlrydw - smsrpjdagk) View more	-	17 Aug 2020
IAS2017	Not Applicable	HIV Enteropathy	274	Crofelemer 125mg bid	cypwzldbwh(lliqtstoto) = ayrsurbeje iewzuumccj (njochlmhkv )	-	01 Jan 2017

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