Psyence BioMed Finalizes Agreement with Award-Winning CRO Southern Star Research to Accelerate Phase IIb Clinical Trial
Psyence BioMed (NASDAQ: PBM) has finalized a service agreement with Southern Star Research, an award-winning Australian CRO, to manage their Phase IIb clinical trial investigating psilocybin-assisted psychotherapy for Adjustment Disorder in cancer patients. The double-blind, placebo-controlled study will enroll 87 participants to assess three doses of psilocybin combined with psychotherapy.
Southern Star Research, recipient of the 2024 Asia-Pacific Competitive Strategy Leadership Award, brings 14 years of expertise in oncology and mental health trials. They will oversee full trial management, including clinical monitoring, project management, and data handling. The study addresses a significant unmet need, as Adjustment Disorder affects up to 19% of cancer patients.
Additionally, FDA Commissioner Marty Makary has expressed support for psychedelic medicine, promising an "expeditious and rapid review" of clinical data from psychedelic trials under the Trump administration.
Psyence BioMed (NASDAQ: PBM) ha concluso un accordo di servizio con Southern Star Research, una CRO australiana premiata, per gestire il loro studio clinico di Fase IIb che indaga la psicoterapia assistita da psilocibina per il Disturbo da Adattamento nei pazienti oncologici. Lo studio in doppio cieco e controllato con placebo arruolerà 87 partecipanti per valutare tre dosi di psilocibina in combinazione con la psicoterapia.
Southern Star Research, vincitrice del premio Asia-Pacific Competitive Strategy Leadership 2024, vanta 14 anni di esperienza in studi oncologici e di salute mentale. Si occuperanno della gestione completa dello studio, inclusi monitoraggio clinico, gestione del progetto e trattamento dei dati. Lo studio risponde a un bisogno significativo non soddisfatto, poiché il Disturbo da Adattamento colpisce fino al 19% dei pazienti oncologici.
Inoltre, il Commissario FDA Marty Makary ha espresso sostegno per la medicina psichedelica, promettendo una "revisione rapida e celere" dei dati clinici provenienti dagli studi psichedelici durante l'amministrazione Trump.
Psyence BioMed (NASDAQ: PBM) ha cerrado un acuerdo de servicio con Southern Star Research, una CRO australiana galardonada, para gestionar su ensayo clínico de Fase IIb que investiga la psicoterapia asistida con psilocibina para el Trastorno de Adaptación en pacientes con cáncer. El estudio doble ciego y controlado con placebo inscribirá a 87 participantes para evaluar tres dosis de psilocibina combinadas con psicoterapia.
Southern Star Research, galardonada con el Premio de Liderazgo en Estrategia Competitiva Asia-Pacífico 2024, aporta 14 años de experiencia en ensayos oncológicos y de salud mental. Supervisarán la gestión completa del ensayo, incluyendo monitoreo clínico, gestión de proyectos y manejo de datos. El estudio aborda una necesidad significativa no cubierta, ya que el Trastorno de Adaptación afecta hasta al 19% de los pacientes con cáncer.
Además, el Comisionado de la FDA, Marty Makary, ha expresado su apoyo a la medicina psicodélica, prometiendo una "revisión rápida y expedita" de los datos clínicos de los ensayos psicodélicos durante la administración Trump.
Psyence BioMed (NASDAQ: PBM)는 호주에서 수상 경력이 있는 CRO인 Southern Star Research와 서비스 계약을 체결하여 암 환자의 적응장애에 대한 실로시빈 보조 심리치료를 조사하는 2b상 임상시험을 관리합니다. 이 이중맹검 위약 대조 연구에는 87명의 참가자가 등록되어 심리치료와 결합된 세 가지 용량의 실로시빈을 평가할 예정입니다.
2024년 아시아-태평양 경쟁 전략 리더십 상을 수상한 Southern Star Research는 종양학 및 정신 건강 임상시험 분야에서 14년의 전문성을 보유하고 있습니다. 이들은 임상 모니터링, 프로젝트 관리 및 데이터 처리 등 전체 시험 관리를 담당합니다. 이 연구는 적응장애가 암 환자의 최대 19%에 영향을 미치는 중요한 미충족 수요를 다룹니다.
또한 FDA 국장인 Marty Makary는 환각제 의학에 대한 지지를 표명하며 트럼프 행정부 시절 환각제 임상 데이터에 대해 "신속하고 빠른 검토"를 약속했습니다.
Psyence BioMed (NASDAQ : PBM) a finalisé un accord de service avec Southern Star Research, un CRO australien primé, pour gérer leur essai clinique de phase IIb explorant la psychothérapie assistée par psilocybine pour le trouble d'adaptation chez les patients atteints de cancer. L'étude en double aveugle contrôlée par placebo recrutera 87 participants afin d'évaluer trois doses de psilocybine combinées à la psychothérapie.
Southern Star Research, récipiendaire du prix Asia-Pacific Competitive Strategy Leadership 2024, apporte 14 ans d'expertise dans les essais en oncologie et en santé mentale. Ils superviseront la gestion complète de l'essai, incluant la surveillance clinique, la gestion de projet et le traitement des données. L'étude répond à un besoin important non satisfait, le trouble d'adaptation affectant jusqu'à 19 % des patients atteints de cancer.
De plus, le commissaire de la FDA, Marty Makary, a exprimé son soutien à la médecine psychédélique, promettant une "examen rapide et expéditif" des données cliniques issues des essais psychédéliques sous l'administration Trump.
Psyence BioMed (NASDAQ: PBM) hat eine Dienstleistungsvereinbarung mit Southern Star Research, einem preisgekrönten australischen CRO, abgeschlossen, um ihre Phase-IIb-Studie zu leiten, die psilocybin-unterstützte Psychotherapie bei Anpassungsstörungen bei Krebspatienten untersucht. Die doppelblinde, placebokontrollierte Studie wird 87 Teilnehmer einschließen, um drei Dosierungen von Psilocybin in Kombination mit Psychotherapie zu bewerten.
Southern Star Research, Preisträger des Asia-Pacific Competitive Strategy Leadership Award 2024, bringt 14 Jahre Erfahrung in Onkologie- und psychischen Gesundheitsstudien mit. Sie werden das vollständige Studiemanagement übernehmen, einschließlich klinischer Überwachung, Projektmanagement und Datenverarbeitung. Die Studie adressiert einen bedeutenden ungedeckten Bedarf, da Anpassungsstörungen bis zu 19 % der Krebspatienten betreffen.
Darüber hinaus hat FDA-Kommissar Marty Makary seine Unterstützung für psychedelische Medizin bekundet und eine "zügige und schnelle Prüfung" der klinischen Daten aus psychedelischen Studien unter der Trump-Administration versprochen.
- Partnership with award-winning CRO Southern Star Research brings 14 years of expertise in oncology and mental health trials
- FDA Commissioner's support and commitment to expedited review of psychedelic trials
- Addressing significant market opportunity with 19% prevalence rate of Adjustment Disorder in cancer patients
- Well-structured Phase IIb trial with 87 participants to test three doses of psilocybin
- Transition from previous CRO could potentially cause delays or complications
- Complex trial design requiring coordination of both psychotherapy and drug administration
- Regulatory uncertainty despite FDA commissioner's positive stance
Insights
Psyence BioMed's new CRO partnership strategically positions their Phase IIb psilocybin trial for operational excellence with potential regulatory advantages.
This CRO transition represents a strategic operational upgrade for Psyence's Phase IIb psilocybin trial. Southern Star Research brings specialized expertise in both oncology and mental health - precisely the intersection where this trial operates. The double-blind, placebo-controlled study examining three psilocybin doses across 87 participants addresses Adjustment Disorder in cancer patients - a condition affecting up to
The partnership offers three distinct advantages: First, Southern Star's established site relationships across Australia should accelerate recruitment - typically the most time-consuming aspect of trials. Second, their award-winning status (2024 Asia-Pacific Competitive Strategy Leadership Award) suggests operational excellence that could minimize protocol deviations. Third, their full-service capabilities covering monitoring, project management, and data handling creates integration efficiencies.
What's particularly notable is the timing of this transition. Mid-study CRO changes often signal operational challenges, but Psyence emphasizes "seamless handover" planning. The FDA Commissioner's comments regarding "expeditious and rapid review" of psychedelic trial data represent an unexpected regulatory tailwind for Psyence's development program. This external validation from a key regulatory figure under the new administration potentially de-risks the approval pathway, assuming the trial generates positive efficacy data.
New York, New York--(Newsfile Corp. - May 27, 2025) - Psyence BioMed (NASDAQ: PBM) ("Psyence BioMed" or the "Company"), a biopharmaceutical company developing nature-derived psilocybin therapies for unmet mental health needs, today announced the finalization of its service agreement with Southern Star Research Pty Ltd ("Southern Star Research"), an award-winning, full-service Australian Contract Research Organization (CRO). This agreement marks a pivotal advancement for Psyence BioMed's Phase IIb clinical trial in Australia, which investigates psilocybin-assisted psychotherapy for Adjustment Disorder in patients with cancer.
With more than 14 years of operational excellence, Southern Star Research brings deep therapeutic area expertise, particularly in oncology and mental health, and maintains strong relationships across clinical sites throughout Australia. Their demonstrated ability to manage complex, multi-site trials ensures high standards of quality, regulatory compliance, and patient-centric execution. U.S based Frost & Sullivan recently recognized Southern Star Research with the 2024 Asia-Pacific Competitive Strategy Leadership Award.
Southern Star Research's robust clinical operations team will now oversee full trial management. This includes clinical monitoring, project management, and data handling, enabling Psyence BioMed to accelerate the study's progression while maintaining operational integrity. The transition from the previous CRO has been carefully coordinated to ensure a seamless handover of responsibilities.
"Southern Star Research's clinical excellence, hands-on approach to focused oncology and mental health trials, and deep understanding of Australia's regulatory environment make them an outstanding partner," said Dr. Neil Maresky, CEO of Psyence BioMed. "Their involvement positions us to execute this important trial efficiently and effectively, helping us deliver on our promise to support cancer patients experiencing serious psychological distress. We are truly excited to move forward with this agreement."
"We are proud to support Psyence BioMed's innovative Phase IIb clinical trial," said Dr. David Lloyd, Managing Director and Co-Founder of Southern Star Research. "Our combination of oncology and mental health expertise, robust site relationships, focus on rapid recruitment of patients, and practical operational involvement contributes to supporting this important research as it progresses with rigor and compassion. We are honored to contribute to the development of a potential new therapeutic option in this space."
The double-blind, placebo-controlled trial will assess three doses of psilocybin in combination with psychotherapy, enrolling 87 participants. The study targets a significant unmet need: Adjustment Disorder in patients diagnosed with cancer. Studies have shown that an Adjustment Disorder prevalence rate of up to
Additionally, in a recent interview with NewsNation, FDA Commissioner Marty Makary expressed a notably positive stance on psychedelic medicine, citing the growing body of evidence supporting its potential benefits for neuropsychiatric conditions. He confirmed that the FDA will undertake an "expeditious and rapid review" of clinical data from psychedelic trials. This signifies further potential for the psychedelic sector.
"We are optimistic about the momentum building around psychedelic medicine, particularly as regulatory leaders begin to recognize its potential and prioritize research," said Dr. Neil Maresky, CEO of Psyence BioMed, in response to Commissioner Makary's remarks. "We view this as a clear signal that psychedelic therapies are becoming a renewed focus for the FDA under the Trump administration - reflecting both scientific progress and the urgent need for new mental health solutions."
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.
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.
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 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/253456
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