atai invests $50m in Beckley Psytech

Beckley Psytech has announced that it has received substantial strategic investment from Germany-based atai Life Sciences, totalling $50 million, to accelerate the clinical development of short-duration psychedelics.

Reflecting the potential for industry growth despite the recent economic climate - and serving to establish Britain as a leading hub for psychedelic research - the deal comprises $40 million as direct investment into Beckley Psytech in order to fund ongoing research programmes, with an additional $10 million allocated for secondary share purchases from existing stakeholders.

atai’s strategic investment in Beckley Psytech reinforces the company’s position as the biopharma with the largest and most diverse portfolio of clinical-stage psychedelic candidates.

Specifically, the financing will support Beckley Psytech in advancing BPL-003, a novel intranasal formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT, or Mebufotenin) that is currently being explored as a potential therapeutic for Treatment Resistant Depression (TRD). It will also suppor thte advancement of ELE-101, a novel IV psilocin benzoate that is being developed as a potential treatment for Major Depressive Disorder (MDD). Psilocin is the primary moiety of psilocybin.

BPL-003 is currently in development for two indications - TRD and also Alcohol Use Disorder (AUD) - with three clinical trials underway. The first trial is a global, multi-site, double-blind, randomised Phase 2b study in people living with TRD, evaluating the effects of a medium and high dose of BPL-003 against an active placebo comparator in 225 patients with moderate-to-severe TRD.

Medium and high dosages were found to reliably induce profound psychedelic experiences in a completed Phase I trial, with a rapid onset of psychedelic effects within minutes and the resolution of all perceptual effects within 60-90 minutes.

Several clinical readouts are anticipated from Beckley Psytech’s studies in the next 18 months, including from the Phase IIb study of BPL-003 in TRD at the end of 2024. In addition to this, BPL-003 is also being investigated in two small Phase IIa open-label studies in TRD and AUD, with data expected in the first half of 2024 and mid-2024, respectively.

atai’s investment comes at a time when psychedelic medicines are being developed more broadly as clinical treatments. One recent example was the December 2023 submission by MAPS Public Benefit Organization of the first ever application to the FDA for a psychedelic as a treatment, MDMA-assisted therapy in treating PTSD. The application was made after two large Phase 3 studies produced impressive results.

Christian Angermayer, founder and chairman of atai, said: “This transaction underscores our conviction in the potential of psychedelics as groundbreaking treatments for people living with mental health disorders. Short-duration psychedelics have the potential to offer similar clinical benefit to longer-acting psychedelics, in a more efficient and scalable way, which could lead to increased patient access.”

Beckley Psytech’s CEO, Cosmo Feilding Mellen, commented: “Beckley Psytech and atai Life Sciences share a vision for the future of mental health treatment, and we are excited to join forces on the journey to develop effective, accessible, rapid-acting psychedelic medicines for people in need.”

atai’s co-founder and CEO, Florian Brand, added: “When it comes to mental health, there is no one-size-fits-all solution, and the diverse pharmacology of our drug candidates acknowledges the heterogeneity of neuropsychiatric patient populations.”

Under the terms of the agreement Beckley Psytech will remain an independent, privately-owned company and atai will own 35.5% of Beckley Psytech. Upon closing, atai will receive 1:1 warrant coverage at a 30% premium on the primary issuances. It will also have the right to appoint and hold 3 of the 9 seats in Beckley Psytech’s Board of Directors, and hold a time-limited right of first refusal on a future sale of the company, asset sales, or other transfer of commercial rights, as well as an indefinite right of first negotiation for BPL-003 and ELE-101.

According to Bloomberg, atai’s shares rallied this week on the back of positive news from an MDMA trial, giving it a market value of $249 million.

Meanwhile, there is competition: at the beginning of December, Cybin unveiled its phase 2 results with its psilocybin analogue CYB003 in MDD, which it said supports moving the drug into a phase 3 programme, given “rapid, robust, and clinically significant” improvement in depression symptoms after a single 12 mg dose.

Stigma around psychedelics remains, however. For more on this and the importance of the therapist in delivery of such treatments, tune into the podcast below to hear insights into the field from Dr Sarah Bateup, therapy lead at Clerkenwell Health, a British start-up working to revolutionise the clinical research landscape by providing a holistic one-stop hub for drug development, trial design, and treatment delivery for complex mental health and neurological conditions.