Psilocybin Breakthrough: One-Dose Depression Treatment Shows Lasting Results

COMPASS Pathways Plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, welcomes the White House Executive Order on accelerating medical treatments for serious mental illness.

"We commend the Administration's Executive Order on psychedelic treatment which recognizes the profound urgency of the mental health crisis facing millions of Americans and the potential impact FDA-approved psychedelics could have," said Kabir Nath, CEO at Compass Pathways. "Today's announcement aligns regulatory urgency with patient need, and we applaud the Administration for taking this important step forward in accelerating access, without compromising rigorous science. Compass is conducting the largest, most robust classic psychedelic studies to date with COMP360 synthetic psilocybin. We have recently reported two positive phase 3 trials in treatment-resistant depression (TRD) with highly statistically significant and clinically meaningful data that demonstrates effects within one day and durability lasting at least through 6 months after just one or two doses for those who have a clinically meaningful response, as well as a generally well-tolerated and safe profile. We are already actively working with the FDA on a rolling submission and review for COMP360 in TRD and look forward to continuing our efforts to bring this potential transformative treatment to the millions of Americans in need."

Nath continued, "An estimated four million Americans are living with TRD and 13 million with PTSD - two conditions that have seen critically limited innovation for decades and where we have late-stage clinical programs underway, as well as ongoing work with the VA. With today's Executive Order including the potential for accelerated regulatory and rescheduling processes, should COMP360 be approved, we will be ready to make this treatment available to patients."

COMP360's transformative clinical profile

COMP360 is the first classic psychedelic to consistently achieve a highly statistically significant result and clinically meaningful effect in two phase 3 studies, with a generally well-tolerated and safe profile. With data generated across more than 1,000 participants living with treatment-resistant depression, COMP360's transformative clinical profile is redefining rapidity and durability for TRD patients. Unlike any other approved treatment available for this patient population today, COMP360 may demonstrate effects as quickly as within one day with durability lasting at least through 6 months, after only one or two doses, for those who achieve a clinically meaningful response. With respect to COMP360's safety profile, a significant majority of treatment-emergent adverse events (TEAEs) are mild or moderate in severity, and the vast majority resolve within 24 hours. Based on this data, we are actively working with the FDA on a rolling submission and review for COMP360 in TRD.

Compass also continues to chart the path forward for patients living with PTSD. After receiving clearance for their IND in this indication, the Company is starting a late-stage trial.

About Compass Pathways

COMPASS Pathways Plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).

Compass is headquartered in London, UK, with offices in New York in the U.S. We envision a world where mental health means not just the absence of illness but the ability to thrive.