The joining of psychedelic specialists Beckley Psytech Ltd. and Atai Life Sciences can now go ahead after the pair announced positive top-line results from the phase IIb study of BPL-003, an intranasal formulation of 5-MeO-DMT benzoate.
Hitting the primary endpoint on Compass Pathways plc’s Comp005 study of synthetic psilocybin, which the company billed as the first classic psychedelic to report phase III efficacy data, produced only a shrug from investors.
Newco Elkedonia SAS has raised €11 million (US$12.7 million) in a seed round, which will fund it to take a potentially first-in-class ELK-1 inhibitor into the clinic in the treatment of refractory depression. ELK-1 plays a pivotal role in neuroplasticity and in reward circuits in the brain, which when disrupted can lead to depression, addiction and post-traumatic stress disorder.
Newco Elkedonia SAS has raised €11 million (US$12.7 million) in a seed round, which will fund it to take a potentially first-in-class ELK-1 inhibitor into the clinic in the treatment of refractory depression. ELK-1 plays a pivotal role in neuroplasticity and in reward circuits in the brain, which when disrupted can lead to depression, addiction and post-traumatic stress disorder.
London-based Livanova plc. has petitioned the U.S. CMS to cover vagus nerve stimulation device for treatment-resistant depression without the need for a clinical trial — a change that would eliminate the costly and cumbersome coverage with evidence development mechanism.
Privately held Beckley Psytech Ltd. is to be taken over by Atai Life Sciences in an all-share deal that values the U.K. psychedelic drug specialist at $370 million. After making a $50 million investment in January 2024, Berlin-based Atai already owns 36% of Beckley. It will now issue 105 million new shares to its fellow Beckley investors, giving them 34% ownership of the merged company.
The credibility gap in psychedelic drug development continues to narrow with positive top-line data from a Beckley Psytech Ltd. phase IIa study in depression. The results keep the treatment into a tight race with GH Research plc, which also has an inhalable drug in development.
The phase IIb study results of Supernus Pharmaceuticals Inc.’s SPN-820 in treatment-resistant depression had pulled the company’s stock (NASDAQ:SUPN) down 15.6% on Feb. 19. The randomized, double-blind, placebo-controlled study of adults failed to show a statistically significant improvement on the primary endpoint of change from baseline on the Montgomery-Åsberg Depression rating scale. Shares closed at $33.52 apiece on Feb. 19.
Mira Pharmaceuticals Inc. has released new preclinical study results for its oral ketamine analogue, Ketamir-2, which is under investigation for potential to treat neurological and neuropsychiatric disorders, including depression, treatment-resistant depression and post-traumatic stress disorder.
On the heels of positive phase II results of its extended-release ketamine (R-107) in treatment-resistant depression, Douglas Pharmaceuticals Ltd. is gearing up to begin phase III trials of its ketamine treatment that is safe enough to take at home without clinical supervision.