- Exclusive Industry Role: Avextra is the industry partner in the first EU-funded project focused on psychedelic-assisted therapy for patients in palliative care suffering from depression, with a total grant of over 6.5 million EUR from the Horizon Europe fund.
- Pioneering Research: The grant will fund the first multi-centre Phase II study across four European countries, with the University Medical Center Groningen in the Netherlands as sponsor.
- Collaborative Effort: 19 partner organizations (universities, companies, foundations, institutes and patient organizations) from 9 European countries formed the PsyPal consortium to address significant unmet patient need.
- Patient-Centered Approach: PsyPal will evaluate the safety and efficacy of psilocybin-assisted therapy as an innovative therapeutic option to improve mental health, well-being, and overall quality of life for patients suffering from life-limiting or life-threatening diseases and their caregivers.
- Expanded Pipeline: The PsyPal trial is part of Avextra’s expanding Phase 2 research portfolio, with multiple clinical trials across Europe, including ongoing studies in Italy and Germany.
BENSHEIM, Germany, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Avextra is proud to announce the EU approval of the groundbreaking PsyPal study, the first EU-funded research into psilocybin-assisted therapy, scheduled to commence in 2025. Supported by a €6.5 million grant from Horizon Europe—the EU's flagship program for research and innovation—this pioneering randomized controlled trial will examine psilocybin’s potential to ease psychological distress in palliative care patients across four European countries: Denmark, Portugal, the Netherlands, and Czechia.
The PsyPal study represents a historic milestone as the first EU-funded investigation into psilocybin therapy. It was initiated by a multidisciplinary pan-European consortium comprising clinical sites, universities, companies, and non-profits, all united in their commitment to advancing psychedelic therapies in palliative care.
Avextra was selected as exclusive provider of the study drug by the consortium earlier this year. It will supply both the study drug and placebo while providing critical regulatory support to the consortium throughout the submission process. Avextra is committed to continuing supporting the study towards Marketing Authorization (MA), aiming to broaden patient access to groundbreaking therapies. With a proven track record of securing regulatory approvals across its pipeline of exploratory studies, Avextra is strategically positioned as a leader in the development and future commercialization of innovative botanical medicines.
PsyPal is the first clinical trial to examine the safety, efficacy, and long-term impact of psilocybin therapy for non-oncology palliative care patients suffering from one of four different progressive diseases: the lung condition chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS, also known as MND), and atypical Parkinson’s disease (APD). The study will also explore patient access models and evaluate its impact on caregivers, emphasizing the importance of holistic care for both patients and their families.
The multidisciplinary consortium spearheading the study comprises 19 organizations from nine countries. It is coordinated by the University Medical Centre Groningen in the Netherlands, in partnership with HumanKindLabs, a key catalyst in advancing psychedelic clinical research focused on set and setting and integrating optimized treatment protocols into mainstream practice.
“This study is a testament to what’s possible when academia, industry, and patient advocates unite for a common cause. Together, we’re creating a holistic approach that addresses terminal illness care in a comprehensive way,” said Ulf Bremberg, CEO of HumanKindLabs.
“For Avextra, PsyPal is not a one-off but an additional milestone of our clinical journey. We are paving the way for a future where psychoactive plant-based substances seamlessly integrate into evidence-based mainstream health care,” said Bernhard Babel, CEO of Avextra.
Learn More
Further details about the PsyPal project and its groundbreaking work can be found at the following links:
About Avextra AG
Avextra is one of Europe’s leading vertically integrated medical cannabis and research operators focused on developing and producing regulatory-approved medicines. Founded in 2019 and based in Germany, Avextra collaborates closely with doctors and pharmacists to create precisely formulated cannabis-based medicines. With cultivation facilities in Portugal and EU-GMP-certified manufacturing in Germany, Avextra ensures the highest standards of quality and innovation in every stage of its operations.
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