Psilocybin

The high court sides with HHS on HIV PrEP drugs; Health Secretary RFK Jr.’s newly appointed CDC vaccine advisors discuss thimerosal in flu vaccines, skip vote on Moderna’s mRNA-based RSV vaccine; FDA removes CAR T guardrails; AbbVie snaps up Capstan for $1.2B to end first half; and psychedelics take off again with data from Compass and Beckley. > Listen on Spotify > Listen on Apple Products > Listen on Amazon Music > Listen on iHeart The U.S. Supreme Court closed out its session before breaking for summer on Friday, ruling that decisions around coverage of HIV PrEP drugs should be left up to the U.S. Preventive Services Task Force. The ruling thwarted a lawsuit brought by a group of insurance providers who challenged the Affordable Care Act’s requirement that they cover preventive medicines, such as HIV drugs, recommended by the task force. The high court also determined that members of this task force can be removed at will by HHS Secretary Robert F. Kennedy Jr. Speaking of HHS committees from which members have been removed at will by Kennedy, the CDC’s revamped Advisory Committee on Immunization Practices convened last week for its first meeting since the roster overhaul, where a vote on Merck’s recently approved RSV-targeting monoclonal antibody Enflonsia and a discussion around the inclusion of preservative thimerosal in influenza vaccines was on the docket, but an expected vote on Moderna’s mRNA-based RSV shot mRESVIA was not . Also dominating the headlines on Friday was the FDA’s decision to remove the Risk Evaluation and Mitigation Strategies (REMS) program from the six approved CAR T therapies it was applied to. Analysts and patient groups lauded the move, which is expected to potentially double access to these life-saving therapies, saying it reflects “thoughtful consideration of real-world evidence” and “regulatory trust.” Willliam Blair noted that it could be a “positive signal” to companies developing CAR T therapies for autoimmune diseases, which now includes AbbVie . In an all-cash buyout on Monday, the Illinois-based pharma dropped $1.2 billion for Capstan Therapeutics and its in vivo edited CAR T therapy for B cell–mediated autoimmune diseases. M&A has been on an uptick of late, and private equity companies —such as those that snapped up bluebird bio—are also getting in on the game. Finally, after Lykos Therapeutics’ high pro last summer, the psychedelics space is heating up once again. While a Phase III readout of Compass Pathways ’ psilocybin drug last week in treatment-resistant depression received a muted reaction from investors, the response to a Phase II readout for Beckley Psytech and atai Life Sciences ’ intranasal psychedelic was more positive.

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.