Relmada Therapeutics Initiates Phase 1 Dosing with REL-P11 for Metabolic Disease
Relmada Therapeutics has initiated Phase 1 dosing of REL-P11, a proprietary low-dose, modified-release psilocybin formulation for metabolic disease. The Single-Ascending Dosing (SAD) study will evaluate safety and pharmacokinetics in obese and normal weight subjects. Preclinical rodent studies presented at AASLD 2023 demonstrated improved metabolic parameters without detrimental CNS effects. With positive results, the company plans to advance to a Phase 2a proof-of-concept study in H1 2025.
Relmada Therapeutics ha avviato la somministrazione della fase 1 di REL-P11, una formulazione brevettata di psilocibina a bassa dose e a rilascio modificato per malattie metaboliche. Lo studio di Dosaggio Ascendente Singolo (SAD) valuterà la sicurezza e la farmacocinetica in soggetti obesi e di peso normale. Studi preclinici su roditori presentati all'AASLD 2023 hanno dimostrato miglioramenti nei parametri metabolici senza effetti negativi sul sistema nervoso centrale. Con risultati positivi, l'azienda prevede di avanzare a uno studio di fase 2a di dimostrazione del concetto nel primo semestre del 2025.
Relmada Therapeutics ha iniciado la dosificación de la Fase 1 de REL-P11, una formulación patentada de psilocibina de baja dosis y liberación modificada para enfermedades metabólicas. El estudio de Dosificación Ascendente Única (SAD) evaluará la seguridad y la farmacocinética en sujetos obesos y de peso normal. Los estudios preclínicos en roedores presentados en AASLD 2023 demostraron mejoras en los parámetros metabólicos sin efectos perjudiciales en el sistema nervioso central. Con resultados positivos, la empresa planea avanzar a un estudio de prueba de concepto de fase 2a en la primera mitad de 2025.
Relmada Therapeutics는 대사 질환에 대한 독점 저용량 수정 방출 실로시빈 제제인 REL-P11의 1상 투약을 시작했습니다. 단일 상승 용량(SAD) 연구는 비만 및 정상 체중 대상자에서 안전성과 약리학적 동태를 평가할 것입니다. AASLD 2023에서 발표된 전임상 쥐 연구는 해로운 CNS 효과 없이 개선된 대사 매개 변수를 보여주었습니다. 긍정적인 결과가 나올 경우, 회사는 2025년 상반기에 2a상 개념 증명 연구로 진행할 계획입니다.
Relmada Therapeutics a lancé le dosage de phase 1 de REL-P11, une formulation de psilocybine à faible dose et à libération modifiée, réservée aux maladies métaboliques. L'étude de dosage ascendant unique (SAD) évaluera la sécurité et la pharmacocinétique chez des sujets obèses et à poids normal. Des études précliniques sur des rongeurs présentées à l'AASLD 2023 ont démontré des améliorations des paramètres métaboliques sans effets néfastes sur le système nerveux central. Avec des résultats positifs, la société prévoit de passer à une étude de phase 2a de preuve de concept au premier semestre de 2025.
Relmada Therapeutics hat die Dosierung in Phase 1 von REL-P11, einer proprietären, niedrig dosierten und modifiziert freigesetzten Psilocybin-Formulierung für Stoffwechselerkrankungen, begonnen. Die Studie zur einzelnen aufsteigenden Dosierung (SAD) wird die Sicherheit und Pharmakokinetik bei fettleibigen und normalgewichtigen Probanden bewerten. Bei der AASLD 2023 präsentierte präklinische Studien an Nagetieren haben eine Verbesserung der metabolischen Parameter ohne nachteilige CNS-Effekte gezeigt. Bei positiven Ergebnissen plant das Unternehmen, im ersten Halbjahr 2025 zu einer Phase-2a-Konzeptnachweisstudie überzugehen.
- Advancement to clinical phase with initiation of Phase 1 trials
- Positive preclinical results showing improved metabolic parameters
- Clear development timeline with Phase 2a planned for H1 2025
- None.
Insights
REL-P11 is a proprietary, low-dose, modified-release psilocybin formulation
Single-Ascending Dosing (SAD) study to evaluate safety and pharmacokinetics
in obese and normal weight subjects
With positive results, Phase 2a proof-of-concept study expected to begin in H1 2025
CORAL GABLES, Fla., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced the initiation of dosing in a Phase 1 SAD study of REL-P11, an investigational agent for metabolic disease.
“Dosing of the first subjects in the Phase 1 study is an important milestone for REL-P11, a low-dose, modified-release psilocybin formulation. Preclinical rodent studies, published at the American Association for the Study of Liver Disease in 2023 (AASLD 2023), showed that treatment with REL-P11 improved multiple metabolic parameters with no detrimental CNS effects, and suggest that REL-P11 could have potential to become a valuable therapeutic option in the evolving obesity and metabolic syndrome space,” said Sergio Traversa, Chief Executive Officer of Relmada. “We expect the Phase 1 study to help define the pharmacokinetic, safety and tolerability profile of REL-P11 and, with positive data, pave the way for a Phase 2a proof-of-concept study to begin in H1 2025.”
About REL-P11 and the Phase 1 Study
Relmada acquired the development and commercial rights to a novel psilocybin and derivatives program in July of 2021. Psilocybin has neuroplastogen™ effects that have the potential to ameliorate neurodegenerative conditions. Relmada identified the potential to use low-dose psilocybin as a treatment for metabolic diseases and published the data at the American Society for the Study of Liver Disease (AASLD 2023).
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Relmada's experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada's lead program, REL-1017, is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 is in late-stage development as an adjunctive treatment for MDD in adults. Learn more at www.relmada.com.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects”, "anticipates”, "believes”, "will”, "will likely result”, "will continue”, "plans to”, "potential”, "promising”, and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential failure of clinical trial results to demonstrate statistically and/or clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect the complete results of the trial, failure of the Reliance-OLS (study 310) to accurately reflect the results of the ongoing Reliance II (study 302) and Relight (study 304) blinded, randomized and controlled studies of REL-1017, failure of the ongoing Phase 1 and planned Phase 2a trials of REL-P11, the Company’s low-dose, modified release formulation of psilocybin, to be successfully carried out, failure to obtain regulatory approval of REL-1017 for the treatment of major depressive disorder, and the other risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.
Investor Contact:
Tim McCarthy
LifeSci Advisors
Tim@LifeSciAdvisors.com
Media Inquiries:
Corporate Communications
media@relmada.com
FAQ
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