Psi-Driven Progress: Compass Pathways’ Phase 3 Psilocybin Trial Nears Critical Juncture

Oliver BlakeTuesday, Apr 22, 2025 6:32 am ET
15min read

Compass Pathways’ announcement that all participants in Part A of its Phase 3 COMP005 trial for treatment-resistant depression (TRD) have completed dosing marks a pivotal moment for the psychedelics-driven mental health revolution. With top-line 6-week efficacy data expected by late June 2025, investors now face a high-stakes inflection point for a therapy that could redefine care for millions.

The Trial’s Design: A Rigorous Blueprint for Psilocybin’s Potential

The COMP005 trial, the largest randomized, placebo-controlled study of synthetic psilocybin (COMP360) to date, enrolled 258 TRD patients across 32 U.S. sites. Participants received a single 25 mg dose of COMP360 or placebo following antidepressant washout—a critical step given TRD’s definition as failure to respond to at least two prior treatments. The trial’s three-phase structure aims to measure both immediate and sustained efficacy:
- Part A: Blinded through 6 weeks, with the primary endpoint focusing on symptom reduction (measured via the Montgomery-Åsberg Depression Rating Scale).
- Part B: Blinded through 26 weeks, evaluating durability of response.
- Part C: An open-label extension to 52 weeks, assessing long-term safety and efficacy.

Crucially, the trial’s 6-week data—due in late June 2025—will determine whether COMP360 can deliver rapid antidepressant effects, a hallmark of psychedelics. Positive results could position Compass to file for FDA approval as early as 2026, capitalizing on its Breakthrough Therapy designation and the U.K.’s ILAP status.

The TRD Market: A $20B Opportunity with No Silver Bullet

TRD affects approximately 100 million people globally, with patients facing severe disability, elevated suicide risk, and a 30–50% mortality rate higher than the general population. Current treatments—like ketamine or esketamine—are costly, carry abuse potential, or require frequent dosing, leaving a massive unmet need. Analysts estimate the global TRD market could exceed $20 billion annually by 2030, with psilocybin’s single-dose model offering a cost-effective, durable alternative.

Prior data from Compass’ Phase 2b trial (COMP001) showed striking results: a single 25 mg dose reduced depressive symptoms by 40% at week 3 versus placebo, with effects lasting 12 weeks. Follow-up data (COMP004) further revealed median time to relapse at 92 days for 25 mg, versus 62 days for lower doses—a signal of dosing precision that could differentiate Compass in a crowded psychedelic pipeline.

Regulatory and Competitive Dynamics: Compass’s Edge

Compass holds a first-mover advantage in psilocybin’s clinical development, with Phase 3 data generation years ahead of rivals like MindMed or Numinus. The FDA’s Breakthrough Therapy designation accelerates review timelines, while the U.K.’s ILAP pathway prioritizes access for life-altering treatments.

However, risks remain. Competitors like Usona Institute are advancing their own psilocybin trials, and regulatory hurdles—such as proving safety in vulnerable populations or establishing clear dosing protocols—could delay approvals.

Investment Implications: A Bifurcated Outlook

The June 2025 data readout is the single most critical event for Compass investors. A positive 6-week result would likely trigger a 20–30% stock surge, reflecting the trial’s de-risking of the regulatory path. Conversely, a miss could send shares plummeting, given the trial’s outsized weight in the company’s valuation.

Longer-term, Compass’s commercial success hinges on:
1. Payer Reimbursement: Securing insurance coverage for a single-dose therapy (projected at $10,000–$15,000 per treatment), which could be challenged in cost-conscious healthcare systems.
2. Clinical Adoption: Convincing psychiatrists to adopt a non-traditional treatment requiring specialized therapy sessions—a logistical hurdle.

The Bottom Line: A High-Reward, High-Risk Psychedelic Play

Compass Pathways stands at the vanguard of psychedelic medicine, with its Phase 3 trial offering a rare chance to validate psilocybin’s potential in a rigorously controlled setting. The June 2025 data is a binary catalyst for investors, but even a partial win could cement COMP360’s position as the first FDA-approved psilocybin therapy.

With TRD’s $20B market beckoning and no approved single-dose alternative, the stakes couldn’t be higher. For bulls, the 6-week data could unlock a $1.5–2 billion market cap, while bears will await 26-week durability data to confirm sustained efficacy. Either way, Compass has set the stage for a landmark chapter in mental health innovation—one dose at a time.

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