• Exclusive Industry Role: Avextra is the sole industry partner in a pioneering EU-funded project investigating psychedelic-assisted therapy for palliative care patients with depression. The project received over €6.5 million in funding from Horizon Europe.
  • Pioneering Research: This funding supports a groundbreaking multi-center Phase II clinical trial across four European countries, led by the University Medical Center Groningen.
  • Collaborative Effort: The PsyPal consortium, comprising 19 organizations from nine European countries, aims to address unmet needs in palliative care.
  • Patient-Centered Approach: The PsyPal study will assess the safety and efficacy of psilocybin-assisted therapy to enhance mental health, well-being, and quality of life for patients with life-limiting illnesses and their caregivers.
  • Expanded Pipeline: The PsyPal trial is part of Avextra’s growing Phase 2 research portfolio, which includes ongoing trials in Italy and Germany.

BENSHEIM, Germany, Dec. 12, 2024 — Avextra proudly announces the EU approval of the innovative PsyPal study, the first EU-funded research into psilocybin-assisted therapy, launching in 2025. This €6.5 million Horizon Europe-funded, randomized controlled trial will investigate psilocybin’s potential to alleviate psychological distress in palliative care patients across Denmark, Portugal, the Netherlands, and Czechia.

The PsyPal study marks a significant advancement as the first EU-funded psilocybin therapy research project. It’s a collaborative undertaking involving a pan-European consortium of clinical sites, universities, companies, and non-profit organizations dedicated to advancing psychedelic therapies in palliative care.

Avextra was chosen as the exclusive study drug supplier by the consortium earlier this year. It will provide both the study drug and placebo, offering crucial regulatory support throughout the submission process. Avextra is committed to supporting the study toward Marketing Authorization (MA), aiming to increase patient access to these innovative therapies. With a proven track record of securing regulatory approvals for its exploratory studies, Avextra is strategically positioned to lead in the development and commercialization of innovative botanical medicines.

PsyPal is the first clinical trial to examine the safety, efficacy, and long-term effects of psilocybin therapy for non-oncology palliative care patients with chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), or atypical Parkinson’s disease (APD). The study will also explore patient access models and evaluate the impact on caregivers, underscoring the importance of holistic care.

The multidisciplinary consortium leading the study comprises 19 organizations from nine countries. It’s coordinated by the University Medical Centre Groningen in the Netherlands, in partnership with HumanKindLabs, a key player in advancing psychedelic clinical research, focusing on optimized treatment protocols.

“This study demonstrates the potential of collaboration between academia, industry, and patient advocates. We’re creating a holistic approach to terminal illness care,” said Ulf Bremberg, CEO of HumanKindLabs.

“For Avextra, PsyPal is a significant milestone in our clinical journey. We’re paving the way for plant-based psychoactive substances to become integrated into evidence-based healthcare,” 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 a leading European vertically integrated medical cannabis and research operator focused on developing and producing regulatory-approved medicines. Founded in 2019 and based in Germany, Avextra works closely with doctors and pharmacists to develop precisely formulated cannabis-based medicines. With cultivation facilities in Portugal and EU-GMP-certified manufacturing in Germany, Avextra maintains high quality and innovation standards throughout its operations.

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