Psyence BioMed Signs LOI with Southern Star Research to Expand Phase IIb Clinical Trial in Australia
Psyence BioMed (NASDAQ: PBM) has signed a Letter of Intent with Southern Star Research, an Australian contract research organization, to expand its Phase IIb clinical trial for psilocybin-assisted therapy. The trial focuses on treating adjustment disorder in cancer patients.
The partnership aims to accelerate the clinical trial timeline by leveraging Southern Star Research's national oncology and mental health network. Adjustment disorder, the seventh most frequently diagnosed psychiatric condition globally, currently lacks FDA-approved pharmaceutical treatments.
The company is transitioning trial management responsibilities from iNGENū CRO to Southern Star Research to ensure operational efficiency. A corporate webinar discussing the new agreement is scheduled for April 10, 2025, at 12:00 PM EST.
Psyence BioMed (NASDAQ: PBM) ha firmato una Lettera di Intenti con Southern Star Research, un'organizzazione di ricerca clinica australiana, per espandere il suo studio clinico di Fase IIb per la terapia assistita da psilocibina. Lo studio si concentra sul trattamento del disturbo di adattamento nei pazienti oncologici.
La partnership mira ad accelerare la tempistica dello studio clinico sfruttando la rete nazionale di oncologia e salute mentale di Southern Star Research. Il disturbo di adattamento, la settima condizione psichiatrica più frequentemente diagnosticata a livello globale, attualmente non dispone di trattamenti farmacologici approvati dalla FDA.
L'azienda sta trasferendo le responsabilità di gestione dello studio da iNGENū CRO a Southern Star Research per garantire efficienza operativa. Un webinar aziendale che discute il nuovo accordo è programmato per il 10 aprile 2025, alle 12:00 PM EST.
Psyence BioMed (NASDAQ: PBM) ha firmado una Carta de Intención con Southern Star Research, una organización australiana de investigación clínica, para ampliar su ensayo clínico de Fase IIb para la terapia asistida por psilocibina. El ensayo se centra en el tratamiento del trastorno de adaptación en pacientes con cáncer.
La asociación tiene como objetivo acelerar el cronograma del ensayo clínico aprovechando la red nacional de oncología y salud mental de Southern Star Research. El trastorno de adaptación, la séptima condición psiquiátrica más diagnosticada a nivel mundial, actualmente carece de tratamientos farmacológicos aprobados por la FDA.
La empresa está transfiriendo las responsabilidades de gestión del ensayo de iNGENū CRO a Southern Star Research para garantizar la eficiencia operativa. Un seminario web corporativo para discutir el nuevo acuerdo está programado para el 10 de abril de 2025, a las 12:00 PM EST.
Psyence BioMed (NASDAQ: PBM)는 호주 계약 연구 기관인 Southern Star Research와 함께 psilocybin 보조 치료를 위한 2b상 임상 시험을 확대하기 위한 의향서를 체결했습니다. 이 시험은 암 환자의 적응 장애 치료에 중점을 두고 있습니다.
이 파트너십은 Southern Star Research의 국가 온콜로지 및 정신 건강 네트워크를 활용하여 임상 시험 일정을 가속화하는 것을 목표로 하고 있습니다. 적응 장애는 전 세계적으로 일곱 번째로 자주 진단되는 정신과적 상태로, 현재 FDA 승인 약물 치료가 없습니다.
회사는 운영 효율성을 보장하기 위해 임상 시험 관리 책임을 iNGENū CRO에서 Southern Star Research로 이전하고 있습니다. 새로운 계약에 대해 논의하는 기업 웨비나는 2025년 4월 10일 오후 12시(EST)로 예정되어 있습니다.
Psyence BioMed (NASDAQ: PBM) a signé une lettre d'intention avec Southern Star Research, une organisation de recherche clinique australienne, pour étendre son essai clinique de Phase IIb pour la thérapie assistée par psilocybine. L'essai se concentre sur le traitement du trouble d'adaptation chez les patients atteints de cancer.
Ce partenariat vise à accélérer le calendrier de l'essai clinique en tirant parti du réseau national d'oncologie et de santé mentale de Southern Star Research. Le trouble d'adaptation, la septième condition psychiatrique la plus fréquemment diagnostiquée dans le monde, ne dispose actuellement d'aucun traitement pharmaceutique approuvé par la FDA.
L'entreprise transfère les responsabilités de gestion de l'essai d'iNGENū CRO à Southern Star Research pour garantir l'efficacité opérationnelle. Un webinaire d'entreprise discutant du nouvel accord est prévu pour le 10 avril 2025 à 12h00 EST.
Psyence BioMed (NASDAQ: PBM) hat eine Absichtserklärung mit Southern Star Research, einer australischen Auftragsforschungsorganisation, unterzeichnet, um die Phase-IIb-Studie zur psilocybinunterstützten Therapie zu erweitern. Die Studie konzentriert sich auf die Behandlung von Anpassungsstörungen bei Krebspatienten.
Die Partnerschaft zielt darauf ab, den Zeitplan der klinischen Studie zu beschleunigen, indem das nationale Netzwerk für Onkologie und psychische Gesundheit von Southern Star Research genutzt wird. Anpassungsstörungen, die weltweit die siebthäufigste diagnostizierte psychiatrische Erkrankung sind, haben derzeit keine von der FDA zugelassenen pharmazeutischen Behandlungen.
Das Unternehmen überträgt die Verantwortung für das Studienmanagement von iNGENū CRO auf Southern Star Research, um die betriebliche Effizienz sicherzustellen. Ein Unternehmens-Webinar zur Diskussion des neuen Vertrags ist für den 10. April 2025 um 12:00 Uhr EST geplant.
- Partnership with established CRO expands clinical trial capabilities
- Access to broader national oncology and mental health network
- Targeting large market opportunity (7th most diagnosed psychiatric condition)
- Addressing unmet medical need with no current FDA-approved treatments
- Transition between CROs may cause temporary operational adjustments
- Still in Phase IIb trials with no guaranteed success
Insights
Psyence BioMed's transition to Southern Star Research represents a strategic operational maneuver for their ongoing Phase IIb trial of psilocybin-assisted therapy. Changing CROs mid-trial typically signals one of two scenarios: either addressing recruitment challenges or scaling up for more efficient execution. The article suggests the latter, with emphasis on Southern Star's broader national oncology and mental health network.
What's particularly notable is the focus on adjustment disorder - a condition affecting millions globally with no FDA-approved pharmaceutical treatments. This positions Psyence in an underserved market segment. The trial specifically targets cancer patients with adjustment disorder, a comorbidity that presents unique recruitment challenges that a specialized oncology-focused CRO might better address.
The transition between CROs introduces short-term operational risks including potential discontinuities in trial management, data handling processes, and site relationships. However, Psyence's explicit mention of a "seamless handover" indicates awareness of these risks. Southern Star's Australian presence is significant as Australia has emerged as a favorable jurisdiction for psychedelic clinical research due to its regulatory framework.
While the announcement lacks specifics on timeline acceleration metrics or recruitment targets, the strategic value lies in accessing Southern Star's established site network, which could meaningfully address patient enrollment - typically the rate-limiting factor in psychiatric clinical trials.
This LOI with Southern Star represents an operational adjustment rather than a transformative catalyst for Psyence BioMed. The company is clearly addressing execution efficiency in their lead clinical program, but investors should note this remains a Letter of Intent, not a finalized agreement.
Psyence's focus on adjustment disorder is strategically sound - ranking as the seventh most frequently diagnosed psychiatric condition globally with no approved pharmaceutical options creates a potential market opportunity with competition. However, the timeline to potential commercialization remains lengthy with this Phase IIb study still in progress.
CRO transitions mid-trial typically signal one of two scenarios: either correcting underperformance or scaling up capabilities. The language suggesting Southern Star's "state-of-the-art operations" and "advanced infrastructure" points toward the latter, though investors should recognize that optimizing clinical operations introduces short-term execution risks during transition periods.
The psychedelic therapeutics sector faces unique clinical trial challenges, including specialized therapeutic protocols and investigator experience. Southern Star's specific expertise in this domain isn't detailed, though their mental health network is highlighted. Most critically, this operational development doesn't fundamentally alter Psyence's regulatory pathway or clinical timeline in the near term.
For a
New partnership strengthens Psyence BioMed's global clinical trial capabilities, accelerating the development of psilocybin-assisted therapy for adjustment disorder
New York, New York--(Newsfile Corp. - April 8, 2025) - Psyence BioMed (NASDAQ: PBM) ("Psyence BioMed" or the "Company") today announced the signing of a Letter of Intent (LOI) with Southern Star Research Pty Ltd, a premier Australian contract research organization (CRO). This collaboration will accelerate Psyence BioMed's ongoing Phase IIb psilocybin clinical trial in Australia, which focuses on adjustment disorder in patients diagnosed with cancer.
Adjustment disorder ranks as the seventh most frequently diagnosed psychiatric condition globally, affecting millions of people who currently have no FDA-approved pharmaceutical treatment.
The engagement of a new CRO represents a pivotal step in optimizing Psyence BioMed's clinical trial, enabling collaboration with a broader national oncology and mental health network to accelerate the Phase II clinical trial timeline. Southern Star Research's scale and capabilities will support the next phase of the Company's clinical development plan. Psyence BioMed thanks iNGENū CRO for their contribution to the protocol design, ethics approval and site activation. To ensure continuity and operational efficiency, Psyence BioMed is coordinating a seamless handover of trial management responsibilities to Southern Star Research as it moves forward with its clinical programs.
"Southern Star Research's state-of-the-art operations, with its advanced infrastructure, national network within Oncology and Mental health, as well as in-depth knowledge of the Australian clinical trial environment will enhance patient recruitment and support efficient trial execution," said Dr. Neil Maresky, CEO of Psyence BioMed. "Their expertise and dedication to clinical excellence make them a strong partner in our mission to develop innovative therapies that address the urgent mental health needs of patients with adjustment disorder."
Dr David Lloyd, Managing Director and Co-Founder of Southern Star Research, expressed enthusiasm for the collaboration, stating: "We are excited to collaborate with Psyence BioMed on the expansion of their Phase IIb clinical trial. This partnership represents a significant step in our long-term commitment to advancing novel psychedelic-assisted therapies for mental health conditions such as adjustment disorder, an area with an enormous unmet need. Our talented team is dedicated to supporting the development of pioneering treatments, and we look forward to contributing to the success of this important clinical trial and many more in the future."
Psyence BioMed senior leadership will discuss the new agreement during the Company's corporate webinar on Thursday, April 10, 2025, at 12:00 PM EST.
To register, please visit: https://psyencebiomed.com/corporate-webinar_april2025/
About Southern Star Research Pty Ltd
Southern Star Research Pty Ltd is an Australian full-service CRO specializing in providing clinical trial services for biotechnology and pharmaceutical companies. With a strong focus on quality and partnership. Southern Star Research is dedicated to advancing clinical research and helping bring innovative therapies to patients.
About Psyence BioMed:
Psyence Biomedical Ltd. (Nasdaq: PBM) is one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in psychedelic-based therapeutics. It is the first life sciences biotechnology company focused on developing nature-derived (non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq. Psyence is dedicated to addressing unmet mental health needs, particularly in palliative care. The name 'Psyence' merges 'psychedelics' and 'science,' reflecting the company's commitment to an evidence-based approach in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for a broad range of mental health disorders.
Learn more at www.psyencebiomed.com and on LinkedIn.
Contact Information for Psyence Biomedical Ltd.
Email: ir@psyencebiomed.com
Media Inquiries: media@psyencebiomed.com
General Information: info@psyencebiomed.com
Phone: +1 416-477-1708
Investor Contact:
Michael Kydd
Investor Relations Advisor michael@psyencebiomed.com
Forward-Looking Statements
This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations, and intentions with respect to future operations, products and services; and other statements identified by words such as "will likely result," "are expected to," "will continue," "is anticipated," "estimated," "believe," "intend," "plan," "projection," "outlook" or words of similar meaning.
Forward-looking statements in this communication include statements regarding the handover and progress of the Phase IIb clinical trial, and trial execution under the newly engaged CRO. These forward-looking statements are based on a number of assumptions, including the assumption that there will be no delays in the execution of the Phase IIb clinical trial implementation schedule, topline data from this trial will be positive, and that the demand for psychedelic-assisted therapy will continue to increase. There can be no assurance that the Company will continue to maintain compliance with Nasdaq's continued listing requirements.
There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements.
These risks and uncertainties include, among others: (i) delays in the execution of the Phase IIb trial; (ii) the ability of Psyence BioMed to maintain the listing of its common shares and warrants on Nasdaq; (iii) volatility in the price of the securities of Psyence BioMed due to a variety of factors, including the recent share consolidation, changes in the competitive and highly regulated industries in which Psyence BioMed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence BioMed's business and changes in Psyence BioMed's capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of the Company's final prospectus (File No. 333-284444) filed with the Securities and Exchange Commission (the "SEC") on January 24, 2025 and other documents filed by Psyence BioMed from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, Psyence BioMed does not intend to update these forward-looking statements.
The Company does not make any medical, treatment or health benefit claims about its proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by authorized clinical research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of the proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company has verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company's performance and operations.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/247722
FAQ
What is the purpose of Psyence BioMed's Phase IIb clinical trial in Australia?
How will the Southern Star Research partnership benefit PBM's clinical trials?
What is the current treatment landscape for adjustment disorder that PBM is addressing?
When will PBM discuss the details of the Southern Star Research agreement?
