Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine news to help you catch up and stay informed
Cybin to Release Phase 2 Topline Data for CYB003 on November 30, 2023
Cybin will host an R&D briefing on Thursday, November 30, 2023, in New York City, at 10:00am ET.
The meeting will feature an overview of the Company’s recently completed Phase 1/2 trial of CYB003, and a detailed review of the topline safety and efficacy data.
Compass Pathways Advances Phase 3 Study & Launches Research Center
- UK sites to participate in part of pivotal phase 3 program following Medicines and Healthcare Regulatory Agency approval of study
- Research will take place in the UK, including at the newly opened Centre for Mental Health Research and Innovation in London, developed in partnership with South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology & Neuroscience at King’s College London
atai Life Sciences Reports Third Quarter 2023 Financial Results and Pipeline Highlights
Atai’s second quarter highlights include:
- Phase 2b study of RL-007 in CIAS patients continues to be on track to report data in 2H 2024 and data from the EMP-01 (MDMA derivative) Phase 1 study is anticipated to report out later this year.
- Phase 1 data of VLS-01 (a proprietary oral transmucosal film formulation of DMT) demonstrated that 160mg of VLS-01 reached exposure levels comparable to 30mg of IV DMT.
- Acceptance of three non-clinical poster presentations at upcoming medical meetings, including non-clinical data for RL-007 and two novel 5-HT2A receptor agonists, EGX-A and EGX-B.
- The Company’s $209M cash position and committed term loan funding is expected to fund operations into 1H 2026.
Awakn Life Sciences Receives Regulatory and Ethical Approval For Phase III Clinical Trial of AWKN-P001
Awakn announces that it has received clinical trial authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) and ethical approval from the Health Research Authority in the UK for a phase III clinical trial for its lead program AWKN-P001 for the treatment of Severe Alcohol Use Disorder (SAUD).
The trial is being funded by Awakn, The University of Exeter, and a partnership between the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC). The phase III trial will be a n=280, two-armed randomized placebo-controlled trial. It will be delivered in the UK across ten UK National Health Service (NHS) sites. Awakn will contribute approx. GBP £800,000 towards the costs of the trial, with the NIHR, the MRC, and the University of Exeter contributing the balance of the costs.
Cybin Reports Second Quarter Financial Results and Recent Business Highlights
Second quarter highlights include:
- Announced positive Phase 2 interim data for CYB003, its proprietary deuterated psilocybin analog, in major depressive disorder
- closing of a unit offering of up to US$64 (C$88.4) million led by one of its largest institutional shareholders
- Strengthened patent portfolio with the addition of four new patents
- Completed acquisition of Small Pharma Inc.
- Topline clinical readout of Phase 1 data for CYB004 and SPL028 expected around year end 2023
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