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 19% has been observed in mixed cancer populations when assessed through clinical interviews, highlighting the significant unmet need for effective mental health treatments in this population.
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.”
Southern Star Research is a full-service Contract Research Organization (CRO) dedicated to navigating the complexities of bringing new medical products to market. With a legacy of excellence that began 14 years ago in Sydney, we have grown from a small, passionate team into a global network of experts committed to delivering high-quality services in medical writing, clinical monitoring, project management, biostatistics, data management, safety and medical monitoring, and quality assurance.
Southern Star Research has been recognized for its outstanding contributions to the field, winning prestigious awards such as the Great Place to Work in Australia in 2024 and 2025, APAC CRO of the Year 2025 and the Frost and Sullivan 2024 Asia-Pacific Competitive Strategy Leadership Award. Our international team continues to deliver innovative clinical trial solutions across diverse therapeutic areas, ensuring the success of every study we manage.
(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.
Simi Barretto
Marketing and Digital Media Manager
Southern Star Research
Location: Australia
Email: media@southernstarresearch.com
L1, 1 Merriwa Street,
Gordon, NSW, 2072 Australia
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