Avextra Backs PsyPal: Landmark Psilocybin Therapy Study for Palliative Care

Key Insights

• Avextra is the industry partner in the PsyPal study, a Phase 2 clinical trial across four European countries, focusing on psilocybin-assisted therapy for palliative care patients with depression.
• The PsyPal study, sponsored by the University Medical Center Groningen, involves 19 organizations from nine countries to address unmet needs in palliative care.
• The trial will assess the safety and efficacy of psilocybin-assisted therapy to improve mental health and quality of life for patients with life-limiting diseases and their caregivers.

Avextra AG is participating as an industry partner in the PsyPal study, a Horizon Europe EU-funded research project investigating psilocybin-assisted therapy. Scheduled to commence in 2025, this randomized controlled trial will explore psilocybin's potential in alleviating psychological distress in palliative care patients across Denmark, Portugal, the Netherlands, and Czechia. The study is sponsored by the University Medical Center Groningen in the Netherlands.

The PsyPal study marks a significant milestone in the field, initiated by a pan-European consortium of clinical sites, universities, companies, and non-profits. Avextra will supply the study drug and placebo, offering regulatory support throughout the submission process. The company aims to support psilocybin therapy for palliative care, working towards Marketing Authorization (MA) to broaden patient access.

Study Focus and Design

PsyPal is designed to evaluate the safety, efficacy, and long-term impact of psilocybin therapy for non-oncology palliative care patients. The trial will focus on individuals suffering from chronic obstructive pulmonary disease (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), and atypical Parkinson’s disease (APD). The study will also explore patient access models and assess the therapy's impact on caregivers.

The multidisciplinary consortium includes 19 organizations from nine countries and is coordinated by the University Medical Centre Groningen, in partnership with HumanKindLabs. Ulf Bremberg, CEO of HumanKindLabs, stated, "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 depression and distress in palliative care in a comprehensive way."

Avextra's Perspective

Bernhard Babel, CEO of Avextra, commented, "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."

Correction

An earlier press release mentioned EU and EMA approval. The study is authorized with conditions according to the Clinical Trials Regulation (CTR).