Compass Pathways CEO: Psychedelics company will 'go slow before we go fast'

Broader field is seen as vulnerable to early negative patient or provider experiences

Kabir Nath, CEO of Compass Pathways, articulated the company’s strategy to approach the rollout of its psychedelic therapy with a deliberate pace, suggesting that negative experiences for patients or providers could have detrimental effects on the wider psychedelics industry, particularly as it approaches its first potential FDA approval.

During his remarks at the STAT Summit in Boston, Nath highlighted the importance of a cautious rollout, acknowledging the significant implications this could have for patients, healthcare providers, and Compass Pathways itself.

Compass is set to finalize a rolling submission to the FDA this quarter for COMP360, its synthetic psilocybin solution aimed at treating individuals with treatment-resistant depression, with aspirations to launch in the early part of next year.

Nath indicated that if the FDA grants approval, the treatment could be subject to a Risk Evaluation and Mitigation Strategy (REMS). The company is also focusing on the training of healthcare providers to administer the therapy properly.

In contrast to traditional antidepressants, which often require weeks and daily doses to demonstrate efficacy, psilocybin has exhibited the potential for rapid and enduring benefits after only a few doses. In Compass’s Phase 3 trials, approximately 25% of patients reported a meaningful clinical response after just one session of COMP360—comprising an extensive six-hour supervised treatment—and this figure increased to around 40% following an additional dose three weeks later. Nath further noted that the longer-term data suggest that patients responding positively can sustain their benefits for as long as a year after two or three doses.

Scientific Questions Remain

Steven Hyman, a Harvard University professor and past director of the National Institute of Mental Health, addressed the ongoing scientific uncertainties surrounding psychedelic therapies, particularly regarding the measurement of their efficacy in clinical trial settings.

One significant hurdle is that patients typically recognize they are receiving a psychedelic treatment due to its unique effects, which can compromise the double-blinding essential to rigorous trials. This concern was paramount when a therapy based on MDMA from Lykos Therapeutics was rejected by the FDA in 2024.

"The issue of unblinding is a persistent challenge," Hyman commented.

He posed another critical question: whether the psychedelic experience is an essential element for the therapeutic effects of these drugs.

Several companies are exploring compounds that may deliver antidepressant effects without inducing hallucinations or intense subjective experiences. Should these developments succeed, such treatments could potentially be prescribed for home use, removing the necessity for extensive supervised sessions.

"Separating these effects would be significant, as it would allow prescriptions to be provided for at-home administration," Hyman remarked. "However, this remains uncertain."

This issue also impacts psychotherapy, traditionally regarded as integral to psychedelic treatment.

Nath shared that Compass opted to separate psychotherapy from its clinical trials, asserting that the company's focus is on developing the drug rather than dictating the methods of psychological care provided by physicians. He mentioned that an analysis of recorded treatment sessions revealed roughly 80% of the treatment time involved no verbal interaction.

Hyman suggested that psychotherapy following the psychedelic experience could play a critical role in aiding patients to process intense emotions and memories. Nonetheless, he emphasized that research has yet to establish how much of the clinical benefits stem from the drug's pharmacological effects versus the experience itself.

Credibility Through Rigor

The conversation also examined the risks associated with hastening the introduction of psychedelic treatments into the market—especially in light of past support for expedited developments by officials in the Trump administration.

Hyman asserted that the field's credibility is contingent on comprehensive research, responsible marketing practices, and meticulous long-term safety monitoring.

"I say this without intending to be humorous," Hyman remarked. "It is imperative to present this research with the utmost seriousness—the path to gaining credibility lies in maintaining absolute rigor."

He drew parallels with the cannabis sector, wherein initial perceptions of safety didn't foresee all risks tied to increasingly potent products.

Pricing and Access Challenges

Should COMP360 receive FDA approval, another pressing challenge will be ensuring affordability and accessibility for patients.

When queried about potential pricing in relation to Johnson & Johnson's Spravato, an esketamine treatment for depression, Nath acknowledged that Spravato serves as a reference point but did not confirm specific pricing details.

The overall costs associated with the treatment would extend beyond the drug itself, given the necessary hours of clinical monitoring. Nath indicated that Compass has dedicated extensive time to developing reimbursement frameworks for that monitoring and is actively collaborating with commercial insurers and the Centers for Medicare and Medicaid Services to secure appropriate coverage.

For Hyman, the potential of psychedelics is unmistakable, particularly in light of the current limitations of depression treatments. However, their emergence also highlights the significant gaps in psychiatry regarding the biological mechanisms of depression and the variability of patient responses to different treatments.

"We continue to be entwined in subjectivity," he noted, emphasizing the absence of objective biomarkers that could assist researchers in identifying patients most likely to benefit from specific drugs.