A Phase 1, Open-label, Single Dose Study to Evaluate the Concentration of RE104 and Its Major Metabolites in Breast Milk and Plasma of Healthy Lactating Women.

The purpose of this study is to obtain data necessary to characterize the elimination of RE104 and metabolites from breastmilk of health lactating volunteers to support a regulatory assessment of when mothers can safely return to breastfeeding following a single-dose of RE104 for Injection.

开始日期2024-11-13

申办/合作机构

Reunion Neuroscience, Inc.

NCT06342310 / Recruiting临床2期

A Multicenter, Randomized, Double-Blind, Parallel-Group Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Patients With Postpartum Depression (PPD)

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-placebo.

开始日期2024-06-14

申办/合作机构

Reunion Neuroscience, Inc.

100 项与 RE-104 相关的临床结果

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100 项与 RE-104 相关的转化医学

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100 项与 RE-104 相关的专利（医药）

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项与 RE-104 相关的文献（医药）

2024-06-19·ACS Chemical Neuroscience

RE104: Synthesis and Activity of a Novel Serotonergic Psychedelic Prodrug of 4-Hydroxy-N,N-diisopropyltryptamine

Article

作者: Bryson, Nathan ; Ehlers, Michael D. ; Alexander, Robert

Results from randomized clin. trials of psilocybin in depressive disorders highlight the therapeutic potential of serotonergic psychedelic compounds in mental health disorders.The synthetic 5-hydroxytryptamine 2A receptor agonist 4-hydroxy-N,N-diisopropyltryptamine (4-OH-DiPT) is structurally similar to psilocin but is reported to have a shorter duration (2-3 h) of psychedelic effects, suggesting the potential for psilocybin-like therapeutic activity with reduced clin. resource burden.Here, we describe the preclin. and translational characterization of RE104, a 4-OH-DiPT prodrug comprising a glutarate moiety designed to cleave rapidly in situ and thus provide reasonable bioavailability of the active drug.Plasma concentration of 4-HO-DiPT over time in PK experiments in rats was correlated with head-twitch intensity.The half-life of 4-OH-DiPT was 40 min after s.c. administration of RE104 in rats.In a forced swim test, a single dose of RE104 (1 mg/kg) significantly reduced mean immobility time at 1 wk compared with vehicle (P < 0.001), confirming translational antidepressant potential.Taken together, these data with RE104 show that the glutarate ester can act as an efficient prodrug strategy for 4-HO-DiPT, a unique short-duration psychedelic with potential in depressive disorders.

项与 RE-104 相关的新闻（医药）

2024-10-09

·GlobeNewswire-Health Care

Reunion Neuroscience Partners with Seleni Institute on Effective Diagnosis and Treatment of Maternal Mental Health Disorders

Reunion to Sponsor Scholarships that will Train Healthcare Professionals on Maternal Mental Health Disorders, including Postpartum Depression Reunion’s Phase 2 RECONNECT Study in Postpartum Depression is Actively Recruiting Patients MORRISTOWN, N.J., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc., a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic therapeutic solutions, today announced a new partnership with the Seleni Institute, a New York City based nonprofit that provides treatment and training regarding maternal mental health and wellness issues. This partnership will grant healthcare professionals access to the Seleni Institute’s comprehensive, evidence-based training on maternal mental health conditions such as perinatal mood and anxiety disorders (PMADs) and perinatal grief. The courses provide expert instruction on the effective diagnosis and treatment of reproductive and maternal health disorders including postpartum depression (PPD). “At Reunion, we recognize the urgent need to address and increase awareness of maternal mental health conditions, which affect 1 in 5 women during pregnancy or following childbirth. Through our partnership with the Seleni Institute and sponsorship of evidence-based training courses, we aim to ensure that healthcare professionals have access to valuable educational resources to more effectively diagnose and treat maternal mental health disorders,” said Greg Mayes, President and Chief Executive Officer of Reunion Neuroscience. “In tandem with this partnership, we continue to support the broader maternal mental health community with the advancement of our Phase 2 RECONNECT trial evaluating our lead candidate RE104 in adult female patients with moderate-to-severe PPD.” The RECONNECT Phase 2 clinical trial (NCT06342310), a multicenter, randomized, double-blind, active dose-controlled clinical trial is evaluating the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with moderate-to-severe PPD. To learn more about the study and eligibility for enrollment, please visit www.ppdreconnectstudy.com. “We are thrilled to partner with Reunion Neuroscience in our shared mission to support maternal mental health,” said Seema Bajaj, Executive Director of the Seleni Institute. “Through this sponsorship, Reunion is collaborating in our initiative to provide access to valuable training materials to better equip healthcare providers with the knowledge and tools necessary to properly address these critical issues, including PPD. We are proud to continue our combined efforts to further increase awareness and reduce stigma around reproductive and maternal mental health conditions.” Since its inception in 2011, the Seleni Institute has been at the forefront of advancing maternal mental health, having trained over 6,200 professionals across 30 countries and impacted more than 10 million lives globally. Seleni offers a hybrid approach that includes clinical services for individuals, couples, and families as well as accredited training for healthcare providers. About Reunion Neuroscience Inc.Reunion Neuroscience is a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic therapeutic solutions. In August of 2023, Reunion Neuroscience became a private company and in May 2024, the Company completed a Series A financing co-led by MPM BioImpact and Novo Holdings. Reunion is actively investigating the use of its lead product candidate, RE104, in postpartum depression, as well as in additional neuropsychiatric indications, including adjustment disorders in patients diagnosed with mental illnesses like cancer, where there remains a significant unmet need that is not addressed by the current standard of care. For more information about the company, visit https://reunionneuro.com. About the Seleni InstituteThe Seleni Institute is a leading therapy center and global training organization committed to advancing women’s mental health through all stages of reproductive life. As a recognized leader in maternal and reproductive mental health, Seleni provides specialized therapy services for individuals, couples, and families navigating challenges such as infertility, pregnancy, and menopause, while equipping health professionals with the tools to diagnose and treat reproductive mental health issues effectively. Founded in 2011 by George and Nitzia Logothetis, Seleni has positively impacted over 10 million lives worldwide. Learn about how Seleni supports mental health for life’s milestones at seleni.org and explore the organization’s training curriculum at training.seleni.org. For more information on the Seleni Scholarship and to apply, please visit Seleni Scholarship for Maternal Mental Health Professionals. For further information: IR Inquiries:Courtney MogerleyPrecision AQcourtney.mogerley@precisionaq.com PR Inquiries:Ashley Murphy Precision AQashley.murphy@precisionaq.com

临床2期

2024-09-10

·GlobeNewswire-Health Care

Reunion Neuroscience Appoints Mark Pollack, M.D., as Chief Medical Officer

MORRISTOWN, N.J., Sept. 10, 2024 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc., a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic therapeutic solutions, today announced the appointment of Mark Pollack, M.D., as Chief Medical Officer. Dr. Pollack previously served as a member of Reunion’s Advisory Board and is a highly accomplished psychiatrist with decades of leadership experience in neuroscience-focused drug development and clinical research. Pollack replaces Dr. Robert Alexander who will continue to remain involved with Reunion as a strategic advisor. “Dr. Pollack has been on the forefront of medical advances in treating patients with mental health disorders, and as a former member of our Advisory Board, his prior experience and significant expertise will be instrumental in our efforts to advance our clinical programs, including the recently launched Phase 2 RECONNECT study in postpartum depression” said Greg Mayes, President and Chief Executive Officer of Reunion. “His proven track record of success in medical affairs and drug development coupled with deep knowledge in neuropsychiatry will be important as we continue to progress our RECONNECT Phase 2 trial evaluating RE104 in postpartum depression (PPD).” “Reunion’s lead candidate, RE104, the only prodrug of 4-OH-DiPT in development, is designed to deliver fast-acting, durable therapeutic benefits to patients and has the potential to make a significant impact for a broad range of mental health disorders, particularly within the postpartum depression and adjustment-disorder patient populations” said Mark Pollack, M.D. “I have been impressed with the company’s approach to the development of novel psychedelics and look forward to collaborating further with the team to execute on our clinical milestones, particularly advancing the RECONNECT Phase 2 trial, as we work to revolutionize treatment outcomes for patients worldwide.” Dr. Pollack has nearly four decades of experience holding both strategic and scientific leadership positions in neuroscientific research and pharmaceutical development. He most recently served as Senior Vice President for Global Medical Affairs at Sage Therapeutics, where he focused on cultivating external relationships with the scientific community as part of a broad medical thought leader engagement strategy. Prior to joining Sage, he served as Chief Medical Officer of Neuroscience at Myriad Genetics. Previously, Dr. Pollack was the Chairman of the Department of Psychiatry and Behavioral Sciences at Rush University Medical Center and Director of its Mental Health Service Line. Prior to Rush, he served as the Director of the Center for Anxiety and Traumatic Stress Disorders and was a Professor of Psychiatry at Massachusetts General Hospital (MGH) and Harvard Medical School. Dr. Pollack is a past President of the Anxiety and Depression Association of America and former Chair of its Scientific Advisory Board. He holds an M.D. from Rutgers New Jersey Medical School and completed his residency and fellowship in psychiatry at MGH and Harvard Medical School. He has authored over 500 publications and is an internationally renowned lecturer. Reunion Neuroscience is currently advancing the RECONNECT Phase 2 clinical trial (NCT06342310), a multicenter, randomized, double-blind, parallel-group, active dose-controlled clinical trial evaluating the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with moderate-to-severe PPD. To learn more about the study, please visit www.ppdreconnectstudy.com. About Reunion Neuroscience Inc.Reunion Neuroscience is a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic therapeutic solutions. In August of 2023, Reunion Neuroscience became a private company as part of the MPM BioImpact portfolio and in May 2024, the Company completed a Series A financing co-led by MPM BioImpact and Novo Holdings. Reunion is actively investigating the use of its lead product candidate, RE104, in postpartum depression, as well as in additional neuropsychiatric indications, including adjustment disorders in patients diagnosed with mental illnesses like cancer, where there remains a significant unmet need that is not addressed by the current standard of care. For more information about the company, visit https://reunionneuro.com. For further information: IR Inquiries:Courtney MogerleyPrecision AQcourtney.mogerley@precisionaq.com PR Inquiries:Ashley Murphy Precision AQashley.murphy@precisionaq.com

临床2期高管变更

2024-09-04

·GlobeNewswire-Health Care

Reunion Neuroscience Joins the Is Mom OK? Initiative Recognizing Maternal Suicide Prevention Month

Initiative Coincides with Start of Reunion’s Phase 2 RECONNECT Study in Postpartum DepressionMORRISTOWN, N.J., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc., a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic therapeutic solutions, today announced its sponsorship of “Is Mom Ok?” in recognition of Maternal Suicide Prevention Month. This unprecedented initiative, launched by Cherished Mom, a renowned nonprofit organization dedicated to transforming the landscape of maternal mental health, is aimed at providing essential support and resources for pregnant and postpartum women, with a specific focus on addressing maternal suicide and mortality. “Reunion is enrolling patients for our Phase 2 RECONNECT trial evaluating RE104 in adult female patients with moderate-to-severe postpartum depression,” said Greg Mayes, President and Chief Executive Officer of Reunion Neuroscience. “Sadly, maternal suicide remains the second most common cause of death during the postnatal period, and we remain committed to the development of a new and novel treatment in this area of great unmet medical need.” The RECONNECT Phase 2 clinical trial (NCT06342310), a multicenter, randomized, double-blind, active dose-controlled clinical trial is evaluating the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with moderate-to-severe postpartum depression (PPD). To learn more about the study, please visit www.ppdreconnectstudy.com. “We express our gratitude to Reunion Neuroscience for their sponsorship of our Is Mom OK? initiative and applaud their broader commitment to our shared mission of providing support for mothers struggling with mental health during pregnancy or after childbirth and preventing tragic outcomes,” said Kristina Dulaney, RN, PHM-C, Founder and Executive Director of Cherished Mom. “Together, we can more effectively raise awareness, reduce stigma, and advocate for maternal mental health.” Through IsMomOK.org, Cherished Mom aims to create a safe and nurturing space for mothers to access valuable information, connect with a supportive community, and find the resources they need to seek help and support. The platform offers educational materials, expert advice, personal stories, and resources for families experiencing perinatal mental health crises, designed and curated to address the unique needs of mothers who may be experiencing Perinatal Mood and Anxiety Disorders (PMADs), including PPD, which affects roughly 1 in 7 women. Timely, empathetic support and treatment are vital for mitigating mental health risks, supporting mothers, and destigmatizing maternal mental health, encouraging more women and families to seek help. About Reunion Neuroscience Inc.Reunion Neuroscience is a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic therapeutic solutions. In August of 2023, Reunion Neuroscience became a private company and in May 2024, the Company completed a Series A financing co-led by MPM BioImpact and Novo Holdings. Reunion is actively investigating the use of its lead product candidate, RE104, in postpartum depression, as well as in additional neuropsychiatric indications, including adjustment disorders in patients diagnosed with mental illnesses like cancer, where there remains a significant unmet need that is not addressed by the current standard of care. For more information about the company, visit https://reunionneuro.com. About Cherished MomCherished Mom is a nonprofit organization dedicated to transforming the dialogue around Maternal Mental Health. Their mission is to eliminate the stigma associated with PMADs, increase awareness surrounding maternal mental health, and specifically address the critical issues of maternal suicide and mortality. Cherished Mom supports pregnant and postpartum women, families, and perinatal healthcare providers through innovative campaigns, educational programs, resources, and a nurturing community. For further information: IR Inquiries:Courtney MogerleyPrecision AQcourtney.mogerley@precisionaq.com PR Inquiries:Ashley Murphy Precision AQashley.murphy@precisionaq.com

临床2期

100 项与 RE-104 相关的药物交易

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