Iclepertin

Atai Life Sciences pivoted to inidascamine back in 2023 after the biotech’s ketamine-like drug floundered in the clinic. \n Atai Life Sciences’ schizophrenia drug has failed to improve cognition in a phase 2 study, leading the biotech to reaffirm that the therapy is no longer a priority.The drug in question, formerly called RL-007 and now known as inidascamine, is a modulator of the cholinergic, glutamatergic and GABA-B receptors. Recognify Life Sciences, which has been developing the drug, assessed the med in a midstage study of 242 patients in the U.S. and Europe with schizophrenia over six weeks.The trial failed to hit the primary endpoint of demonstrating improvement on a score of cognitive function when compared to placebo, according to atai. Searching for positives, the company pointed out that inidascamine had shown a “modest but consistent numerical improvement” on this score as well as “directionally positive effects” on a measure of real-world cognitive capacity.Inidascamine was well tolerated, with no sign of the side effects commonly seen with schizophrenia treatments such as sedation, weight gain or impacted movement.“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 as well as replication on specific subsets of the cognitive measures; namely, symbol coding and verbal memory,” Recognify CEO Matt Pando, Ph.D., said in the July 25 post-market release.“These findings reinforce our commitment to addressing the significant unmet needs of cognitive impairment associated with numerous mental health and neurodegenerative conditions,” Pando added. “Inidascamine continues to exhibit a strong safety profile, and we look forward to analyzing the full data set to better understand the outcome and inform potential next steps for the program.” After decades of no new options, the schizophrenia space was shaken up last year with the approval of Bristol Myers Squibb’s Cobenfy. Since then, rival candidates from other companies have continued to struggle in the clinic, including Boehringer Ingelheim’s iclepertin and AbbVie’s emraclidine.There remain no FDA-approved treatments specifically for cognitive impairment associated with schizophrenia. Biogen, Roche and Pfizer have studied candidates in the setting but no longer have any active trials. Neurocrine Biosciences was investigating its DAAO inhibitor luvadaxistat in the indication, but those attempts were halted by a phase 2 fail last year.Atai pivoted to inidascamine back in 2023 after the biotech’s ketamine-like drug floundered in the clinic. The company had already incorporated the asset into its pipeline after securing a majority stake in Recognify in 2021.While Recognify said Friday that it will “continue to evaluate strategic options” for inidascamine, atai’s CEO Srinivas Rao, M.D., Ph.D., was clear that the drug has been deprioritized.“While we believe these results support the continued development of inidascamine by Recognify for CIAS as well as its potential application in other indications, as previously communicated, we intend to allocate Atai’s resources on our wholly owned pipeline of transformative psychedelic product candidates focused on affective disorders,” Rao said.

Recognify Life Sciences said its schizophrenia drug candidate failed a mid-stage trial in patients with cognitive impairment, solidifying majority stakeholder atai Life Sciences’ existing plans to become a pure-play psychedelics company. Recognify’s inidascamine did not meet the Phase 2b primary endpoint of improvement on a cognitive function scale called the MCCB at six weeks versus placebo. The scale measures several elements of cognitive function, including attention, memory and problem-solving. Berlin-based atai acquired a majority stake in Recognify four years ago as part of a deal centered on inidascamine. Atai said in a Friday release that it intends to focus its resources on its “wholly owned” psychedelics pipeline “as previously communicated.” Atai’s share price $ATAI was down by as much as 15% on the Nasdaq premarket Monday. Despite the Phase 2b flop, Recognify said inidascamine produced a “modest but consistent numerical improvement” on the MCCB composite score as well as individual elements, including symbol coding, speed of processing and verbal learning, according to the release. The mid-stage trial enrolled 242 patients with cognitive impairment associated with schizophrenia (CIAS). Recognify said it plans to analyse the data further before deciding on next steps for the program. The company will also present Phase 2b results at a future medical meeting. Inidascamine is designed to modulate the cholinergic, glutamatergic and GABA-B receptors. Jefferies analysts said Friday they were “unsurprised” by the inidascamine failure because all mid- or late-stage studies in CIAS have suffered the same fate. In January, Boehringer Ingelheim’s GlyT1 inhibitor iclepertin flunked a Phase 3 trial in CIAS. Another GlyT1 inhibitor developed by Pfizer, tested in combination with cognitive training, failed to improve CIAS symptoms versus cognitive training alone in a Phase 2 test, according to results published in 2023. The Jefferies analysts said atai still has a “compelling” case for other programs in its pipeline, including a synthetic version of 5-MeO-DMT, called BPL-003. The drug passed a Phase 2b test in treatment-resistant depression earlier this month. In June, atai announced plans to merge with another psychedelics biotech called Beckley Psytech to form a new company, Atai Beckley.