National Institute of Mental Health

BEDFORD, Mass.--( BUSINESS WIRE )--Delix Therapeutics, a clinical-stage neuroscience company pioneering novel neuroplasticity-promoting treatments for psychiatric and neurological disorders, today announced that the first patient has been dosed in its Phase 1b clinical trial to evaluate the pharmacodynamics (PD), safety, tolerability, and pharmacokinetics (PK) of DLX-001, a novel non-hallucinogenic neuroplastogen, in Major Depressive Disorder (MDD). “Building on promising preclinical studies that demonstrate DLX-001’s ability to rapidly promote robust structural and functional neuroplasticity within hours, as well as sustained therapeutic effects in animal models of depression, the initiation of this trial represents a pivotal milestone in the development of novel treatments for patients suffering from MDD,” said Aaron Koenig MD, Chief Medical Officer of Delix Therapeutics. “Importantly, data from our Phase 1 first-in-human study demonstrated that DLX-001 achieves therapeutic exposures with predictable PK, a favorable safety and tolerability profile, and no evidence of psychotomimetic, dissociative, or hallucinogenic effects. We are excited to progress this novel first-in-class agent and gain insights that will strengthen the design of our upcoming Phase 2 study in MDD.” The Phase 1b study will evaluate the PD, safety, tolerability, and PK of DLX-001 in approximately 20 patients with MDD. Based on the results of the completed single and multiple ascending dose (SAD-MAD) study in healthy volunteers, patients will receive daily oral DLX-001 over seven days at doses that produced statistically significant changes in quantitative electroencephalography (qEEG) in healthy volunteers. The key objective of the Phase 1b study is to assess effects on translational biomarkers following DLX-001 administration, including qEEG, polysomnography, and other exploratory markers. Preliminary efficacy will also be assessed. Delix is rapidly advancing its library of novel, non-hallucinogenic compounds into scalable, orally bioavailable therapies. The Company’s compounds have demonstrated the ability to promote fast-acting and long-lasting repair of synapses associated with neuropsychiatric and neurodegenerative conditions, without the liabilities inherent to first- and second-generation plasticity-promoting compounds such as LSD, ketamine, psilocybin, and MDMA. About DLX-001 DLX-001 is a novel, non-hallucinogenic, non-dissociative isotryptamine neuroplastogen currently being evaluated for the treatment of Major Depressive Disorder (MDD). Preclinical data has demonstrated that DLX-001 increases dendritic spine density in PFC neurons and has rapid and enduring antidepressant-like effects in animal models after a single dose. Recent Phase 1 data has demonstrated that DLX-001 is associated with robust signs of CNS engagement and a favorable safety and tolerability profile, with no serious adverse events reported to date. About Neuroplastogens Neuroplastogens are a novel class of potentially disease-modifying therapeutics for psychiatric and neurological conditions. These compounds promote rapid and sustained neuroplasticity in select neural circuits resulting in fast-acting therapeutic effects. Neuroplastogens are novel chemical entities inspired by compounds that are proving to be beneficial across a range of neuropsychiatric and neurodegenerative disorders, in addition to other synaptopathies. Leveraging our phenotypic drug discovery engine, Delix is committed to developing a pipeline of cutting-edge neuroplastogens that will target offering faster and more effective therapies addressing the underlying pathophysiology of many neuropsychiatric and neurological diseases. About Major Depressive Disorder (MDD) Major Depressive Disorder (MDD) is a prevalent and debilitating condition affecting over 280 million people globally, 1 with 21 million people suffering in the United States alone. 2 MDD represents the primary cause of disability in the world, 3 and is typically characterized by persistent feelings of sadness and loss of interest. Even with available approaches, many patients do not experience an optimal response to treatment, resulting in a significant need for new and differentiated treatments. 4 About Delix Therapeutics Delix Therapeutics is a clinical-stage neuroscience company focused on harnessing the power of novel neuroplasticity-promoting therapeutics to better treat patients struggling with difficult-to-treat neuropsychiatric and neurological disorders. The company's compounds are easily manufactured small molecules capable of rapidly inducing structural and functional neural changes in targeted areas of the brain. Through its novel Neuroplastogen Platform, Delix is pioneering a new class of fast-acting outpatient pharmacotherapies and rapidly advancing through preclinical and clinical development to bring patients FDA-approved, take-home medicines that will serve several unmet needs and enhance the psychiatric treatment paradigm for patients and providers. References: World Health Organization. Depressive disorder (depression). World Health Organization. Published March 31, 2023. https://www-who-int.libproxy1.nus.edu.sg/news-room/fact-sheets/detail/depression . National Institute of Mental Health. Major Depression. National Institute of Mental Health. Published July 2023. https://www-nimh-nih-gov.libproxy1.nus.edu.sg/health/statistics/major-depression . National Library of Medicine. Major Depressive Disorder. National Institute of Mental Health. Published April 10, 2023. https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/books/NBK559078/ . Rush, A. J., et al. Am J Psychiatry , (2006).

LOS ANGELES, Nov. 14, 2024 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, announced two oral presentations on tuberculosis (TB) therapy that took place at The Union Conference on Lung Health 2024, in Bali, Indonesia. The oral presentation “Six Months is a Lot of Time to Lie:” Disclosure and Treatment Preferences Among Participants in a Tuberculosis Therapeutic Trial was presented by Faith Mugodhi, M.Sc., H.S.W., University of Zimbabwe-Clinical Trials Research Centre (UZ-CTRC). The oral presentation High Prevalence of Fluoroquinolone Resistance and katG Mutations in Adult Index Patients in a Multinational MDR-TB Prevention Trial was presented by Soyeon Kim, Sc.D., IMPAACT Senior Statistician, Frontier Science Foundation. “ACTG is honored to share these important findings with the many global stakeholders who are gathered in Indonesia at the Union Conference,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California, Los Angeles. “TB is one of ACTG’s key research priorities, as the disease remains a leading killer worldwide. The knowledge gained from the research presented today has the potential to inform our approach to TB treatment and ultimately improve the experiences of people with TB.” “Six Months is a Lot of Time to Lie:” Disclosure and Treatment Preferences Among Participants in a Tuberculosis Therapeutic Trial was a sub-study that investigated experiences around disclosure and treatment preferences among participants in ACTG 5362. Also known as CLO-FAST, this multi-center treatment-shortening trial for drug-susceptible TB randomized individuals to receive either a three-month regimen containing clofazimine (which can be associated with skin hyperpigmentation) or the six-month standard of care. The sub-study consisted of exploratory, qualitative in-depth interviews with 23 participants undergoing treatment in CLO-FAST from India, Malawi, and Zimbabwe. This presentation reported that all sub-study participants with TB had voluntarily disclosed their TB status to at least one other person. Nearly half of participants (43.5 percent) feared inadvertent disclosure of their status due to their treatment and attendance at the TB clinic; 80 percent (n=8) of these were taking clofazimine. One in five participants reported experiencing stigma or discrimination as a result of inadvertent disclosure, including being treated badly by their families or communities. Today’s presentation also found that participants had different preferences around the kind of treatment they received. Two-thirds (n=15) of participants reported that they would prefer the shortened regimen even if one of the medications led to a change in their skin color, while one-third (n=8) reported a preference for the longer regimen. That preference was associated with anticipation of stigma and beliefs that a longer regimen is more potent against TB. These data suggest that anticipated stigma and pre-existing beliefs may be important in understanding treatment preferences. High Prevalence of Fluoroquinolone Resistance and katG Mutations in Adult Index Patients in a Multinational MDR-TB Prevention Trial is an analysis from the PHOENIx study, an ongoing clinical trial evaluating the efficacy and safety of preventive treatment for multi-drug resistant TB (MDR-TB) with delamanid compared to isoniazid, conducted jointly by the ACTG and IMPAACT (International Maternal Pediatric Adolescent AIDS Clinical Trials) networks. (IMPAACT is a global collaboration of investigators, institutions, community representatives, and other partners, with a mission to improve health outcomes for infants, children, and adolescents as well as pregnant and postpartum people who are impacted by or living with HIV by evaluating novel treatments and interventions for HIV and its complications for tuberculosis and other related complications, through the conduct of high-quality clinical trials.) Knowledge of drug susceptibility in people with active TB is important for the provision of both efficacious treatment for their TB disease and TB preventive treatment for their contacts. This presentation sought to describe drug resistance patterns in adults with MDR-TB whose household members were approached to participate in PHOENIx. Between June 2019 and October 2023, 1,353 adults with documented MDR-TB were enrolled from 28 sites and 13 countries in Africa, Asia, and Central and South America. Among those for whom isoniazid mutation data were available, 73 percent (n=783 of 1078) had high-level resistance (katG mutations). Among the 699 participants who had fluoroquinolone drug-susceptibility testing available, 20 percent (n=139) had fluoroquinolone resistance. These results suggest that it is important to have non-fluoroquinolone options for TB preventive treatment. They also support the relevance of the PHOENIx trial’s evaluation of delamanid vs. isoniazid for TB preventive treatment in high-risk household contacts of adults with MDR-TB. Primary results of the clinical trial are anticipated in 2027. CLO-FAST is led by John Metcalfe, M.D., Ph.D., M.P.H., University of California San Francisco; Samuel Pierre, M.D., Les Centres Gheskio, Haiti; and Kimberly Scarsi, Pharm.D., M.S., University of Nebraska Medical Center and study drugs were supplied by the Global Drug Facility. PHOENIx is jointly conducted by ACTG and IMPAACT and led by Gavin Churchyard M.B.Ch.B., M.Med., Ph.D., The Aurum Institute NPC; Amita Gupta, M.D., M.H.S., Johns Hopkins University; Anneke Hesseling, M.B.Ch.B., M.Sc., Ph.D., Desmond Tutu TB Centre - Stellenbosch University; and Susan Swindells, M.B.B.S., University of Colorado. Delamanid is supplied for PHOENIx by Otsuka Pharmaceutical Company, Ltd. ACTG is led by Dr. Currier and Joseph J. Eron, M.D., University of North Carolina (ACTG Vice-Chair). The studies are sponsored by the National Institute of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID, which also funds ACTG) under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. IMPAACT is also funded by NIAID with support and co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Institute of Mental Health (NIMH). About ACTGACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at hundreds of locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact:Jenna Conley, ACTGjenna@conleycommunications.net

​NEW YORK, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Sparian Biosciences, Inc. (“Sparian”), a clinical-stage CNS-focused biopharmaceutical company, is proud to announce formation of a Science Advisory Board (SAB) with the appointments of Eric Nestler, M.D./PhD, Frances Levin M.D. and Nathaniel Katz, M.D. The SAB was established around clear areas of expertise related to Sparian’s therapeutic focus on pain and substance use disorders. “We took time to carefully and deliberately construct our SAB to include internationally recognized thought leaders with both academic and industry experience translating cutting edge science and innovative drugs,” said Jeffrey B. Reich, M.D. CEO and Co-Founder of Sparian. “We wanted advisors who were prolific in our clinical space and who were willing to share their time, experience and ideas. It’s a real honor to have Drs Nestler, Levin and Katz join the team and support our mission.” Eric Nestler, M.D./ PhD is the Nash Family Professor of Neuroscience, Director of the Friedman Brain Institute, and Dean for Academic Affairs at the Icahn School of Medicine at Mount Sinai and Chief Scientific Officer of the Mount Sinai Health System. He has served on the Boards of Scientific Counselors of the National Institute on Drug Abuse and of the National Institute on Alcohol Abuse and Alcoholism, on the National Advisory Mental Health Council for the National Institute of Mental Health, the National Advisory Drug Abuse Council for the National Institute on Drug Abuse, as Council Member of the American College of Neuropsychopharmacology (president in 2011) and the Society for Neuroscience (president in 2017). He is a member of the Scientific Advisory Board of the Brain & Behavior Research Foundation and of One Mind, as well as a past member of the Board of Directors of the McKnight Endowment Fund in Neuroscience. He was elected to the National Academy of Medicine in 1998 and the American Academy of Arts and Sciences in 2005. Dr Nestler is the author of more than 725 peer-reviewed publications and reviews. He directs six research projects funded by the National Institute on Drug Abuse and the National Institute of Mental Health. Frances R. Levin, M.D. is the Kennedy-Leavy Professor of Psychiatry at Columbia University and the Chief of the Division on Substance Use Disorders at Columbia University - New York State Psychiatric Institute (NYSPI). She is currently on the Board of Directors for the American Academy of Addiction Psychiatry (AAAP), the College on Drug Dependence (CPDD), and the American Society of ADHD and Related Disorders (APSARD). She is an editorial board member of three journals, past President of the American Academy of Addiction Psychiatry, and past Chair of the APA Council on Addiction Psychiatry. Dr. Levin has written over two-hundred and fifty articles and book chapters and has served as primary investigator on dozens of industry and academic lead clinical trials in substance use disorders. Nathaniel Katz, M.D. was co-founder and former CEO of Analgesic Solutions and Chief Science Officer of WCG – Analgesic Solutions. He is currently President of Ein Sof Innovation and Chief Medical Officer of Chariton Pharmaceuticals. Dr Katz served as Chair of the Advisory Committee, Anesthesia, Critical Care, and Addiction Products Division, United States FDA, from 2000 – 2004. Dr Katz has had over 30 years experience directing, conducting and participating in clinical trials of treatments for pain, both industry-initiated and investigator-initiated, involving pharmaceuticals, non-pharmaceutical analgesics and devices. About Sparian BiosciencesSparian Biosciences is a clinical-stage CNS-focused biopharmaceutical company committed to developing transformational therapies to address significant medical needs. The company was co-founded by Jeff Reich, M.D., and Gavril Pasternak, M.D., Ph.D., and was spun out of Memorial Sloan Kettering Cancer Center (MSK). Sparian has five programs that address acute and chronic pain, opioid use disorder (OUD), acute opioid overdose, and stimulant use disorder (StUD). Sparian is the recipient of two NIDA UG3/UH3 grants and an SBIR grant totaling nearly $41M in NIH support. For more information, visit www.Sparianbiosciences.com.