Last update 01 Nov 2024

Breath Therapeutics, Inc.

Private Company|

United States

Private Company|

United States

Last update 01 Nov 2024

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Pipeline

Deal

Translational Medicine

Overview

Clinical Trials associated with Breath Therapeutics, Inc.

EUCTR2019-000718-13-ES / Unknown statusPhase 2

A Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation. - BOSTON-4

Start Date27 Nov 2019

Sponsor / Collaborator

Breath Therapeutics, Inc.

100 Clinical Results associated with Breath Therapeutics, Inc.

0 Patents (Medical) associated with Breath Therapeutics, Inc.

Literatures (Medical) associated with Breath Therapeutics, Inc.

01 May 2021·TP23. TP023 LUNG TRANSPLANT: OUTCOME PREDICTORS AND THERAPEUTIC OPTIONS

Study Design of Two Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trials Evaluating the Efficacy and Safety of Liposomal Cyclosporin A for Inhalation(L-CsA-i) in Patients with Bronchiolitis Obliterans Syndrome Post Single- (BOSTON-1) or Double- (BOSTON-2) Lung Transplantation

Author: Cuomo, D. ; Hachem, R.R. ; Prante Fernandes, S. ; McGrain, J. ; Monforte Torres, V. ; Boerner, G.

RATIONALE: Bronchiolitis obliterans syndrome (BOS) is the most common form of chronic lung allograft dysfunction, and the major limitation of long-term survival post lung transplantation (LTx). BOS affects up to 50% of LTx recipients within 5 years post-transplant. Currently there are no therapies indicated specifically for BOS. The most common treatment is augmentation of systemic immunosuppression, which has limited efficacy and is associated with deleterious long-term side effects. To address the goal of optimizing immunosuppression as a treatment for BOS, a novel liposomal formulation of cyclosporine A (L-CsA) delivered with an investigational eFlow® Technology nebulizer system (PARI Pharma GmbH) is being investigated. The objective of these two trials is to assess the efficacy and safety of inhaled L-CsA added to standard of Care (SoC) immunosuppression, in adult patients with single (SLT) and double lung transplantation (DLT). METHODS: Adult patients who received a SLT or DLT at least 12 months prior to screening, diagnosed with clinically defined BOS by FEV1 between 85-60% of personal best after transplant are eligible for inclusion. Patients are randomized 1:1 to L-CsA-i (5mg dose for SLT;10mg dose for DLT) twice daily plus SoC or SoC alone. After informed consent has been obtained, a Screening Visit is carried out to check general eligibility for participation. At the Randomization Visit, inclusion and exclusion criteria will be reevaluated and spirometry performed. Safety and tolerability will be assessed by physical examination, vital signs, adverse event reporting, and clinical laboratory parameters at every visit. A total of 11 visits throughout the 48-week treatment period will be performed. At completion of trial period, patients from both treatment groups could be eligible to continue in an open-label extension trial (BOSTON-3). The primary endpoint for both trials is the mean absolute change in FEV1 (mL) from baseline to Week 48 between the treatment groups. Secondary endpoints for both trials include mean change in FEV1/FVC from baseline to Week 48 and time to progression of BOS. The latter endpoint will be assessed in a pooled analysis of both trials. CONCLUSIONS: These phase III trials will help characterize the safety and efficacy of L-CsA-i as add-on therapy to SoC in BOS patients. Despite the COVID-19 pandemic, BOSTON-1 and BOSTON-2 are ongoing, ensuring the integrity of data collection and safety of enrolled patients. .

01 Jan 2020·Journal of Cystic Fibrosis

Antisense oligonucleotide eluforsen is safe and improves respiratory symptoms in F508DEL cystic fibrosis

Article

Author: Drevinek, Pavel ; Paquette-Lamontagne, Nicolas ; Cipolli, Marco ; Elborn, J Stuart ; Pressler, Tacjana ; den Hollander, Wilhelmina ; Tomkinson, Nigel ; De Boeck, Kris ; Montgomery, Sonya ; Henig, Noreen ; Schwarz, Carsten ; Bouisset, Florilene ; Boff, Marie ; Perquin, Jaakko

BACKGROUNDEluforsen is an antisense oligonucleotide designed to bind to the mRNA region around the F508-encoding deletion and restore the cystic fibrosis transmembrane conductance regulator (CFTR) protein function in the airway epithelium. We assessed the safety and tolerability, pharmacokinetics and exploratory measures of efficacy of inhaled eluforsen in cystic fibrosis (CF) patients homozygous for the F508del-CFTR mutation.METHODSThis randomised, double-blind, placebo-controlled, dose escalation 1b study recruited adult CF subjects with a FEV₁ > 70% predicted in four single ascending dose cohorts and four multiple ascending dose cohorts. Primary objectives were safety and tolerability. Secondary endpoints included pharmacokinetics, percent predicted forced expiratory volume in 1 s (ppFEV₁), and Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Symptom Score (RSS).RESULTSSingle and multiple doses of inhaled eluforsen up to 50 mg were safe and well tolerated. A maximum tolerated dose was not established. Systemic exposure was low in all cohorts and lung function remained stable throughout the study. Three of four eluforsen-treated groups in the MAD study demonstrated an improvement in CFQ-R RSS at end of treatment with adjusted mean change from baseline values ranging from 6.4 to 12.7 points. In comparison, there was a mean decrease of 6.5 points in the placebo group from baseline to end of treatment.CONCLUSIONSInhaled eluforsen up to 50 mg dosed 3 times per week for 4 weeks was safe and well tolerated, showed low systemic exposure, and demonstrated improvement in CFQ-R RSS, a relevant measure of clinical benefit in CF patients.

13 Nov 2019·Blood

Economic Burden of Bronchiolitis Obliterans Syndrome (BOS) Following Allogeneic Hematopoietic Stem Cell Transplant (alloHSCT) in Patients with Commercial Insurance in the United States

Author: Healey, Bridget ; Cyr, Philip ; Batt, Katharine ; Henig, Noreen Roth ; Sacks, Naomi

BackgroundBronchiolitis obliterans syndrome (BOS), also known as respiratory chronic Graft versus Host Disease (cGvHD), is an obstructive airway disease of the lungs following alloHSCT that has significant morbidity and mortality. BOS is characterized by T-cell mediated inflammation and fibrosis of bronchiolar walls that reduces the diameter of the bronchioles resulting in progressive and irreversible airflow obstruction.BOS is a well described complication following lung transplant and can also be a complication following alloHSCT, with similar histopathology and clinical symptoms. There is currently no approved therapy for the treatment of BOS. While data on alloHSCT costs are available (Milliman 2017; Broder et al., 2017), little is known about the impact of BOS on healthcare resource use (HRU) and costs in alloHSCT. The aim of this study is to quantify the economic burden of BOS in alloHSCT patients.MethodsWe performed a retrospective analysis of commercial claims data from the IQVIA PharMetrics Plus™ database for patients aged 0-64 who were treated with alloHSCT from 1/1/2007 to 9/30/2017. Patients were observable 12 months before and after index alloHSCT. Those who developed BOS were identified using International Classification of Disease (ICD) diagnosis codes (ICD-9: 491.8, 491.9, 515, 516.34, 561.8; ICD-10: J41.8, J42, J84.09, J84.89, J84.115) and propensity score matched to identify patients who did not develop BOS after alloHSCT. We calculated mean annual per patient rates of hospitalizations, tests and treatments for BOS, as well as costs in the follow-up year for inpatient admissions, Emergency Department (ED) and non-ED outpatient visits, and prescription medications. Costs for the index HSCT were included in the first follow-up year costs. All analyses were repeated for the subset of patients observable in the second post-alloHSCT year. The effect of BOS was estimated as the difference in HRU and costs between the matched BOS and non-BOS alloHSCT patients.ResultsWe identified 161 alloHSCT patients with commercial insurance coverage who developed BOS. A majority were male (60%). Mean age was 51.0 yrs (+/- SD: 12.13); a small proportion (2%) were under age 18. We also identified 161 matched alloHSCT patients who did not develop BOS. More BOS patients were diagnosed with leukemias or lymphomas compared with non-BOS patients (94% vs. 84%) in the pre-alloHSCT year, and more had pulmonary disease (asthma or COPD; 24% vs. 16%). No other differences were statistically significant at p>0.05.In the year following alloHSCT, BOS patients had higher mean per patient annual numbers of inpatient admissions (3.9 [+/- SD: 3.3] vs. 2.6 [+/- SD: 2.5]). More BOS patients received lung function testing, including spirometry (60% vs. 42%), and more were treated with ventilation, oxygen therapy or pulmonary rehabilitation (61% vs. 39%). Costs were higher for BOS patients ($560,048 vs. $408,764), with inpatient costs responsible for most of this difference ($446,622 vs. $300,146). Lung function test costs were over 3 times as high for BOS patients ($35,744 vs. $10,192) and lung function treatment costs 2.5 times as high ($31,761 vs. $7,994). Costs for patients observable in the second post-alloHSCT year were considerably lower, as the costs for the initial alloHSCT costs were reflected in the first year expenditures. Nonetheless, costs remained higher for BOS patients ($72,829 vs. $43,665), with higher inpatient, outpatient and prescription drug costs and HRU (Table, Figure).ConclusionAlloHSCT patients who develop BOS in the U.S. have higher rates of hospitalization and have more lung function tests and treatments, compared with alloHSCT patients with no diagnosis of BOS in the first 1-2 years post-alloHSCT. These higher rates of healthcare service use are accompanied by mean annual per patient costs that are $151,000 higher in the first post-alloHSCT year.DisclosuresSacks: Breath Therapeutics Inc.: Other: Employee of Precision Health Economics (PHE). PHE received funding from Breath Therapeutics for this research. . Healey:Breath Therapeutics Inc.: Other: Employee of Precision Health Economics (PHE). PHE received funding from Breath Therapeutics for this research. . Cyr:Breath Therapeutics Inc.: Other: Employee of Precision Health Economics (PHE). PHE received funding from Breath Therapeutics for this research. . Batt:Breath Therapeutics Inc.: Other: Scientific Adviser to Precision Health Economics (PHE). PHE receieved funding from Breath Therapeutics for this research.. Henig:Breath Therapeutics Inc.: Employment.

News (Medical) associated with Breath Therapeutics, Inc.

20 Oct 2023

·www.biospace.com

Res Nova Biologics Announces First Cancer Patient Treated with FloraStilbene™

Therapeutic Solutions International Immuno-Oncology Subsidiary Makes Abortion Pill-Based Drug Available by Prescription through Cure Stat Rx Compounding Pharmacy ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International, Inc. (TSOI), announced today the successful first treatment of a patient with FloraStilbene™, a patent pending formulation of the abortion pill’s active ingredient, RU486, and pterostilbene. The Company has been utilizing pterostilbene, a naturally occurring analog of resveratrol, found in blueberries, for the treatment of cancer and immune modulation for several years, including being granted a patent on synergies with conventional immunotherapies1. In May of this year, Res Nova signed a collaborative agreement with compounding pharmacy Cure Stat Rx for developing a compounded formulation of FloraStilbene™2. “I have worked with Dr. Ramesh Chigurupati, President, and CEO of Cure Stat Rx for many years and have always been impressed by the efficiency and excellence in ability to provide compounded drugs and formulations,” said Dr. James Veltmeyer, Chief Medical Officer of Res Nova Bio. “We look forward to offering FloraStilbene™ to all patients taking immunotherapy, chemotherapy, or radiation therapy that can benefit from immune stimulation of NK cells, T cells, and dendritic cells.” FloraStilbene™ has previously been shown to enhance immunotherapy of various tumors3, as well as chemotherapy efficacy4. “The strategic objective of Therapeutic Solutions International is to develop intellectual property, use it to seed a subsidiary company, and let the subsidiaries grow and flourish,” stated Timothy Dixon, President, and CEO of Therapeutic Solutions International. “I am extremely proud of the leadership role of Ms. Ramos who in the period of less than a year was able to take FloraStilbene™ from concept to patient. This is literally unheard of in traditional biotechnology development models.” In addition to Res Nova, Therapeutic Solutions International has multiple subsidiaries including a) Campbell Neurosciences, focused on the identification of suicidal propensities using a proprietary test and various interventions5; b) Breath Biologics, which is in discussions with the FDA for its filed Phase I/II trial in COPD6; c) CTE Biologics, which is advancing its clinical stage technology for treating Chronic Traumatic Encephalopathy7; and d) VasoSome Vascular, which is in preclinical development of mesenchymal stem cell derived exosomes for treatment of aortic aneurysms8. “I am thankful for our translational medicine team that has worked closely with Drs Veltmeyer and Chigurupati for making this first patient treatment a reality,” said Famela Ramos, President, and CEO of Res Nova Bio. “Although we plan on performing clinical trials to formally establish a level of efficacy, we believe it is imperative to get this drug into the hands of physicians as soon as possible, and we are thankful for having the opportunity to do this today.” About Therapeutic Solutions International, Inc. Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is . 1 US9682047B2 - Augmentation of oncology immunotherapies by pterostilbene containing compositions - Google Patents 2 Therapeutic Solutions International Spin-Off Res Nova Bio Partners with Cure Stat Rx to Manufacture First in Class Breast Cancer Immunotherapy Product FloraStilbene™ | Business Wire 3 Novel Mechanism of Action of FloraStilbene Suggests Potential for Enhancing Efficacy of Checkpoint Inhibitor, CAR-T Therapies (pharmacytimes.com) 4 FloraStilbene™ Demonstrates Synergy with Conventional Chemotherapy and Immunotherapy in Reducing Triple Negative Breast Cancer | BioSpace 5 Therapeutic Solutions International Spin-Off Campbell Neurosciences Provides Progress Update in Quest for Addressing Suicide as a Medical Condition | Business Wire 6 Spinoff Breathe Biologics to Lead TSOI's Stem Cell Therapy Research | COPD News Today 7 Therapeutic Solutions International Launches Subsidiary Company to Commercialize Clinical Data and IND for Treatment of Chronic Traumatic Encephalopathy (CTE) with JadiCell Universal Adult Stem Cells | Business Wire 8 Therapeutic Solutions Launches VasoSome Vascular Inc. to Commercialize Aortic Aneurysm Treatment - Endovascular Today (evtoday.com)

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Breath Therapeutics, Inc.

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