Relmada Therapeutics Acquires Potential Therapy for Tourette Syndrome from Asarina Pharma AB
Relmada Therapeutics (NASDAQ: RLMD) has acquired Sepranolone, a Phase 2b ready neurosteroid therapy for Tourette syndrome (TS), from Asarina Pharma AB. Sepranolone is a first-in-class GABAA Modulating Steroid Antagonist that targets the GABAA pathway to counteract Allopregnanolone effects in TS and other compulsive disorders.
In a Phase 2a study involving 26 subjects over 12 weeks, Sepranolone demonstrated promising results, including a 28% reduction in tic severity (p=0.051) and significant improvements in secondary endpoints: 69% increase in Quality of Life, 50% reduction in impairment, and 44% reduction in premonitory urge to tic. The treatment showed no CNS off-target effects or systemic side effects.
The company views this acquisition as strategic in addressing unmet needs in CNS disorders and plans to host an investor update on Sepranolone's development later in 2025.
Relmada Therapeutics (NASDAQ: RLMD) ha acquisito Sepranolone, una terapia neurosteroidea pronta per la Fase 2b per la sindrome di Tourette (TS), da Asarina Pharma AB. Sepranolone è un antagonista degli steroidi modulatori del GABAA di prima classe che mira alla via del GABAA per contrastare gli effetti dell'Allopregnanolone nella TS e in altri disturbi compulsivi.
In uno studio di Fase 2a che ha coinvolto 26 soggetti per 12 settimane, Sepranolone ha dimostrato risultati promettenti, inclusa una riduzione del 28% nella gravità dei tic (p=0.051) e miglioramenti significativi negli endpoint secondari: aumento del 69% della qualità della vita, riduzione del 50% dell'impatto e riduzione del 44% dell'urgenza premonitoria al tic. Il trattamento non ha mostrato effetti collaterali off-target nel SNC o effetti collaterali sistemici.
L'azienda considera questa acquisizione strategica per affrontare bisogni insoddisfatti nei disturbi del SNC e prevede di ospitare un aggiornamento per gli investitori sullo sviluppo di Sepranolone nel 2025.
Relmada Therapeutics (NASDAQ: RLMD) ha adquirido Sepranolona, una terapia neuroesteroide lista para la Fase 2b para el síndrome de Tourette (TS), de Asarina Pharma AB. Sepranolona es un antagonista de esteroides moduladores del GABAA de primera clase que se dirige a la vía del GABAA para contrarrestar los efectos de la alopregnanolona en el TS y otros trastornos compulsivos.
En un estudio de Fase 2a que involucró a 26 sujetos durante 12 semanas, Sepranolona demostró resultados prometedores, incluyendo una reducción del 28% en la gravedad de los tics (p=0.051) y mejoras significativas en los puntos finales secundarios: incremento del 69% en la calidad de vida, reducción del 50% en el deterioro y reducción del 44% en la urgencia premotora del tic. El tratamiento no mostró efectos secundarios no deseados en el SNC ni efectos sistémicos.
La compañía considera esta adquisición como estratégica para abordar las necesidades no satisfechas en los trastornos del SNC y planea realizar una actualización para inversores sobre el desarrollo de Sepranolona a finales de 2025.
Relmada Therapeutics (NASDAQ: RLMD)는 Asarina Pharma AB로부터 투렛 증후군 (TS) 치료를 위한 2b 단계 준비가 완료된 신경 스테로이드 치료제인 세프라논론을 인수했습니다. 세프라논론은 GABAA 경로를 목표로 하여 TS 및 기타 강박 장애에서 알로프레그난올론의 영향을 상쇄하는 1세대 GABAA 조절 스테로이드 길항제입니다.
26명의 참가자를 포함한 12주 동안의 2a 단계 연구에서, 세프라논론은 틱의 심각도가 28% 감소하는 등 (p=0.051) 유망한 결과를 보여주었으며, 2차 목표에서 유의미한 개선이 있었습니다: 삶의 질이 69% 증가, 장애가 50% 감소, 틱의 전조에 대한 긴급함이 44% 감소하였습니다. 이 치료법은 CNS의 비표적 효과나 전신적인 부작용을 보이지 않았습니다.
회사는 이 인수가 CNS 장애의 충족되지 않은 요구 사항을 해결하는 데 전략적이라고 생각하며, 2025년 후반에 세프라논론 개발에 대한 투자자 업데이트를 개최할 계획입니다.
Relmada Therapeutics (NASDAQ: RLMD) a acquis Sepranolone, une thérapie neurostéroïdienne prête pour la phase 2b pour le syndrome de Tourette (TS), auprès d'Asarina Pharma AB. Sepranolone est un antagoniste stéroidien modulant le GABAA de première classe qui cible la voie GABAA pour contrer les effets de l'allopregnanolone dans le TS et d'autres troubles compulsifs.
Lors d'une étude de phase 2a impliquant 26 sujets pendant 12 semaines, Sepranolone a montré des résultats prometteurs, y compris une réduction de 28 % de la gravité des tics (p=0.051) et des améliorations significatives dans les critères secondaires : augmentation de 69 % de la qualité de vie, réduction de 50 % de l'impact et réduction de 44 % de l'urgence prémonitoire au tic. Le traitement n'a montré aucun effet secondaire hors cible du SNC ni d'effets systémiques.
L'entreprise considère cette acquisition comme stratégique pour répondre aux besoins non satisfaits dans les troubles du SNC et prévoit d'organiser une mise à jour pour les investisseurs sur le développement de Sepranolone fin 2025.
Relmada Therapeutics (NASDAQ: RLMD) hat Sepranolon erworben, eine neurosteroidale Therapie in Phase 2b für das Tourette-Syndrom (TS), von Asarina Pharma AB. Sepranolon ist ein erstklassiger GABAA-modulierender Steroidantagonist, der den GABAA-Weg anvisiert, um die Effekte von Allopregnanolon bei TS und anderen zwanghaften Störungen zu bekämpfen.
In einer Phase-2a-Studie mit 26 Probanden über einen Zeitraum von 12 Wochen zeigte Sepranolon vielversprechende Ergebnisse, darunter eine 28%ige Reduktion der Tic-Schwere (p=0.051) und signifikante Verbesserungen in sekundären Endpunkten: 69%ige Steigerung der Lebensqualität, 50%ige Reduktion der Beeinträchtigung und 44%ige Reduktion des vorahnenden Bedürfnisses zu tikken. Die Behandlung zeigte keine off-target Wirkungen im ZNS oder systemische Nebenwirkungen.
Das Unternehmen betrachtet diese Akquisition als strategisch, um unerfüllte Bedürfnisse in ZNS-Erkrankungen anzugehen, und plant, später im Jahr 2025 ein Update für Investoren zur Entwicklung von Sepranolon bereitzustellen.
- Phase 2a clinical results showed 28% reduction in tic severity
- Significant secondary endpoint improvements: 69% QoL increase, 50% impairment reduction
- No CNS off-target effects or systemic side effects reported
- Product is Phase 2b ready, indicating advanced development stage
- Primary endpoint p-value of 0.051 slightly missed statistical significance threshold of 0.05
- Small sample size of only 26 subjects in Phase 2a trial
- Treatment requires twice weekly subcutaneous injections, which may affect patient compliance
Insights
This strategic acquisition marks a significant pivot for Relmada, introducing a Phase 2b-ready asset with compelling clinical data in the underserved Tourette syndrome market. The Phase 2a results are particularly noteworthy, showing a
The market opportunity is substantial - current TS treatments like antipsychotics and alpha-2 agonists have significant limitations due to side effects and modest efficacy. Sepranolone's clean safety profile and selective mechanism of action as a GAMSA could position it as a potential first-line treatment, addressing a important market gap.
Key investment considerations include:
- The compound's unique mechanism targeting the GABAA pathway represents a novel approach in TS treatment
- The robust safety profile with no CNS off-target effects significantly de-risks the development pathway
- The twice-weekly subcutaneous administration could present both opportunities (consistent drug levels) and challenges (patient compliance)
- The p-value of 0.051 for the primary endpoint, while just missing statistical significance, shows strong clinical relevance given the magnitude of effect
For Relmada's portfolio strategy, this acquisition represents a calculated diversification move, potentially reducing the company's risk profile by adding a mid-stage asset with demonstrated clinical signals. The timing aligns with management's stated objective of exploring strategic assets, suggesting disciplined execution of their growth strategy.
The clinical data for Sepranolone presents a compelling efficacy and safety profile that could potentially reshape the TS treatment landscape. The Yale Global Tic Severity Scale (YGTSS) reduction of
Several aspects of the Phase 2a results warrant particular attention:
- The
69% improvement in quality of life (GTS-QOL) suggests benefits beyond mere tic reduction - The
50% reduction in impairment and44% decrease in premonitory urge to tic indicate comprehensive symptom control - The absence of CNS off-target effects is crucial, as current treatments often cause sedation, weight gain, or cognitive issues
The selective GABAA pathway modulation represents a novel therapeutic approach, potentially offering more precise intervention in the neurological circuits involved in TS. While the Phase 2a study's sample size (n=26) is modest, the consistency across multiple endpoints and the clean safety profile provide a strong foundation for the upcoming Phase 2b program.
The twice-weekly subcutaneous administration, while requiring patient compliance, could offer advantages in maintaining steady drug levels compared to oral medications. This could be particularly beneficial in managing the fluctuating nature of TS symptoms.
Relmada purchases Sepranolone, a Phase 2b ready asset, for the treatment of Tourette syndrome (TS) and other compulsion-related conditions from Asarina Pharma AB
Phase 2a results signaled improvement in Tourette symptoms, quality of life and robust overall safety, supporting Sepranolone as a new potential first line treatment option for TS
Sepranolone (isoallopregnanolone) is a first-in-class compound from new subgroup of neurosteroids known as GAMSAs- GABAA Modulating Steroid Antagonists - acting selectively on the GABAA pathway, potentially alleviating the negative effect of Allopregnanolone in Tourette syndrome and other compulsive disorders
CORAL GABLES, Fla., Feb. 06, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a clinical-stage biotechnology company, today announced the acquisition of Sepranolone, a Phase 2b ready neurosteroid, from Asarina Pharma AB (Asarina), being developed for the potential treatment of Tourette syndrome (TS) and other compulsive disorders.
“We are very pleased to announce this agreement with Asarina. Sepranolone aligns with our Company’s mission to find solutions for difficult-to-treat central nervous system (CNS) disorders. There is a serious unmet need for improved TS therapies not only reducing tics but also improving quality of life without serious side effects. We have been impressed by the encouraging Phase 2a efficacy signal with clinically meaningful tic reductions and quality-of-life improvements, combined with a robust safety data package showing no CNS off-target effects, that we believe reflect the compound’s selective binding properties,” said Sergio Traversa, Chief Executive Officer of Relmada. “We believe that this transaction is an excellent fit with our objective to build shareholder value by leveraging our core competencies of identifying and developing innovative compounds.”
Luca Pani, MD, Professor of Clinical Psychiatry at the University of Miami Miller School of Medicine, commented, "While current treatments for Tourette syndrome provide only modest tic reduction and are often accompanied by significant side effects, the Phase 2a data suggest that Sepranolone has the potential to offer meaningful symptom relief with a more favorable safety profile. These findings are promising, and I look forward to seeing further clinical development of this novel therapy.”
“Late last year we announced that Relmada would explore strategic assets and strategic options,” commented Maged Shenouda, Chief Financial Officer of Relmada. “Based on our extensive due diligence, including a carefully conducted review of the clinical and regulatory data, and consultation with well-respected outside experts, we believe the promising Phase 2a data suggest that Sepranolone has the potential to become first line treatment for TS.”
Clinical Data on Sepranolone
Sepranolone (isoallopregnanolone) is a first-in-class GABAA Modulating Steroid Antagonist (GAMSA), which selectively targets the GABAA (GABAA) pathway to counteract the effects of Allopregnanolone, a neurosteroid implicated in TS and other compulsive disorders.
Data from an open-label Phase 2a randomized study demonstrated that Sepranolone has the potential to improve TS symptoms versus standard of care alone, as measured by changes in the YGTSS scoring system (the world-standard Yale Global Tic Severity Scale) compared to baseline. In the 12-week, dual-center, parallel-group study, 26 subjects were treated with Sepranolone (10 mg, administered by subcutaneous injection twice weekly in addition to standard of care (SOC) versus standard of care alone.
The Phase 2a results showed competitive tic reduction and improved quality of life while displaying no CNS off-target effects. Sepranolone not only reduced tic severity in its primary clinical endpoint as measured by YGTSS by
no off-target CNS effects or systemic side effects – a crucial metric for CNS drugs in an indication where legacy and new treatments in developments involve sometimes severe side effects
Strategic Outlook
Relmada continues to evaluate additional product and strategic opportunities. The Company anticipates hosting an investor update on Sepranolone’s next development steps later in 2025.
About the Asarina Agreement
Under the terms of the agreement, Relmada acquired full global ownership rights to Sepranolone from Asarina Pharma AB, a Swedish biopharmaceutical company through an asset purchase agreement for EUR 3 Million.
About Neurotransmitter Modulators and Sepranolone
Sepranolone is a pioneering GAMSA that selectively inhibits the effects of Allopregnanolone, a neurosteroid linked to compulsive disorders such as TS and obsessive-compulsive disorder (OCD). Evaluated in multiple clinical neuro/hormonal studies involving over 335 participants, Sepranolone has demonstrated a favorable safety profile.
GABA (γ-aminobutyric acid) is the brain’s primary inhibitory neurotransmitter, helping to regulate anxiety and compulsive disorders. While Allopregnanolone typically enhances GABA’s calming effects, in some individuals it paradoxically exacerbates anxiety and compulsive. Sepranolone normalizes GABAA receptor activity by targeting two specific receptor subtypes (alpha-2 and alpha-4) without directly interfering with GABA signaling, making it a novel and selective treatment approach for TS and related disorders.
Sepranolone is protected by multiple issued patents until 2038.
About Tourette syndrome (TS)
Tourette syndrome is a complex neurological condition characterized by involuntary tics. The Centers for Disease Control and Prevention (CDC) estimates that more than 350,000 children in the U.S. have TS, with onset typically occurring between ages five and ten. Though symptoms often improve in adulthood, many individuals experience chronic tics and associated psychosocial challenges. Existing treatments include dopamine D2 blockers, atypical antipsychotics, botulinum toxin injections, cognitive behavioral therapy (CBIT), and deep brain stimulation, but these options are often limited by significant side effects.
TS is believed to be influenced by genetic, environmental, and neurochemical factors, including the role of Allopregnanolone in triggering compulsive behaviors. Current treatments target dopamine and other neurotransmitters, but the Company believes Sepranolone’s modulation of Allopregnanolone offers a novel and potentially safer alternative.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapies for central nervous system (CNS) and metabolic disorders. With a commitment to advancing breakthrough treatments, Relmada strives to improve patient outcomes and quality of life. For more information, visit 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 planned or ongoing preclinical and clinical studies to recapitulate the results of prior studies, potential failure to secure FDA agreement on the regulatory path for Sepranolone or that future Sepranolone clinical results will be acceptable to the FDA, failure to secure adequate Sepranolone drug supply 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:
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media@relmada.com
FAQ
What are the key Phase 2a results for RLMD's newly acquired Sepranolone?
How is Sepranolone administered to Tourette syndrome patients?
What makes RLMD's Sepranolone different from other Tourette syndrome treatments?
When will RLMD provide updates on Sepranolone's development plans?
