Methylenedioxymetamfetamine

The small, brain-focused biotechnology company Atai Life Sciences plans to direct resources away from an experimental drug it bought into several years ago, now that the therapy has come up short in a mid-stage clinical trial.Atai got access to the drug back in early 2021 by taking a majority stake in its developer, Recognify Life Sciences. The companies have been testing it since in a placebo-controlled study that enrolled nearly 250 people with cognitive impairment tied to schizophrenia. While drug-treated patients did show numerical improvements on measures of cognition and function, Recognify said they werent significantly better than the control group.Recognify noted how its drug, currently called inidascamine, demonstrated favorable safety and was well tolerated by patients. There was no evidence of common side effects associated with schizophrenia treatments, such as weight gain, sedation or a type of motor issue known as extrapyramidal symptoms. Recognify added that researchers are still analyzing the trials secondary and exploratory goals to determine whether there are identifiable responder populations or mechanistic insights that may guide future development.Although we are disappointed that the study did not reach statistical significance on the primary efficacy endpoint, we are encouraged by the consistency of improvement signals across multiple cognitive and functional measures, said Matt Pando, the companys co-founder and CEO, in a statement Friday.Specific data werent disclosed, but Recognify intends to present additional results at upcoming scientific meetings. In the meantime, it will continue to evaluate strategic options for inidascamine based on the totality of data.Srinivas Rao, who co-founded Atai and serves as its CEO, said his team believes that, based on the results generated thus far, Recognify should carry on developing the drug.But if it does, it wont be able to count on Atais backing, as the company has decided to allocate resources on its wholly owned pipeline. That pipeline revolves around psychedelics, with versions of DMT and MDMA being evaluated as possible therapies for social anxiety or hard-to-treat depression. Atai is also in the process of merging with fellow psychedelics specialist Beckley Psytech, in a deal that would give it full control over a couple more clinical-stage programs.One of those Beckley drugs, dubbed BPL-003, is a form of mebufotenin that recently succeeded in a treatment-resistant depression study. The plan now is to push the drug into late-stage testing.Atai shares were down roughly 10% Monday morning, to trade around $3.20 apiece. Ritu Baral, an analyst at TD Cowen, wrote in a note to clients that the inidascamine failure aside, Atai investors remain focused on BPL-003 and the next steps for that program.Inidascamine is an oral drug meant to re-wire the brain by modulating the neurotransmitters glutamate, acetylcholine and GABA. '

The psychedelics sector received a high-profile setback last year when the FDA rejected Lykos Therapeutics’ application for approval of its MDMA therapy for post-traumatic stress disorder. \n Beckley Psytech’s psychedelic drug has successfully reduced the symptoms of depression in a phase 2 study, triggering the next stage of a planned merger with mental health-focused company Atai Life Sciences.The phase 2b trial of 193 patients with treatment-resistant depression evaluated 8-mg and 12-mg doses of the drug, dubbed BPL-003, against a 0.3 mg comparator arm for eight weeks. BPL-003 is an intranasal formulation of mebufotenin or 5-MeO-DMT, a psychedelic substance belonging to the tryptamine family.A single 12-mg dose of BPL-003 was shown to result in the “statistically significant” 11.1-point decrease in depression symptoms at Day 29 as measured on the the Montgomery-Åsberg Depression Rating Scale (MADRS), compared to a 5.8-point decrease for the comparator arm, hitting the primary endpoint of the trial.Meanwhile, the 8-mg dose achieved a similar MADRS reduction of 12.1 points, which Atai said hit a key secondary efficacy endpoint for the study. As both doses appeared to demonstrate similar efficacy, Beckley and Atai suggested that the 8-mg dose “may be sufficient to achieve therapeutic benefit from a single dose.”“Notably, both the 8 mg and 12 mg doses of BPL-003 showed statistically significant improvements in MADRS scores as early as one day after dosing, with effects generally maintained out to week 8,” the companies explained in a July 1 release.When it came to safety, 99% of treatment-emergent adverse events were mild or moderate, said the companies, which noted that there were no drug-related serious adverse events nor suicide-related safety signals.The results hit the criteria required for Atai to proceed with its planned merger with Beckley Psytech, which was first set out last month. Assuming the plan is signed off by Atai’s shareholders, the resulting company, to be named Atai Beckley, should “create a global leader in short-time in-clinic psychedelic-based mental health therapies,” the companies said in this morning’s release. “The achievement of our primary and secondary endpoints in this study represents an important milestone in the development of BPL-003 and reinforces its potential to be a viable treatment option for patients and healthcare systems,” Beckley’s CEO Cosmo Feilding Mellen said in the release.“We are particularly encouraged that a single 8 mg or 12 mg dose of BPL-003 showed rapid and durable efficacy results, favourable tolerability and a short time in-clinic, giving us important flexibility in optimising the design of future trials,” the CEO added. “We now look forward to preparing for end-of-phase 2 meetings with regulators and moving forward with our strategic combination with Atai Life Sciences.”When it comes to nasal sprays for depression, Johnson & Johnson’s Spravato leads the way. The companies said the fact that the majority of patients in the phase 2 trial were deemed ready for discharge at the 90-minutes post-dose assessment “suggests BPL-003 could fit within the existing two-hour in-clinic interventional psychiatry treatment paradigm established by Spravato.”“These findings strengthen our confidence in the potential of BPL-003 to be a transformative psychedelic therapy, offering rapid and durable antidepressive effects with minimal in-clinic time for patients with treatment-resistant depression,” Atai CEO Srinivas Rao, M.D., said in the release. “We look forward to engaging with the regulators later this year to advance this innovative treatment into phase 3 clinical development.”The psychedelics sector received a high-profile setback last year when the FDA rejected Lykos Therapeutics’ application for approval of its MDMA therapy for post-traumatic stress disorder. But recent weeks have seen some good new emerge from the clinic, including a successful phase 3 depression readout for Compass Pathways’ psilocybin treatment.