Compass Pathways to expedite launch of its experimental depression therapy

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By Sneha S K

(Reuters) -Drug developer Compass Pathways said on Tuesday it is pulling forward the expected launch of its experimental psilocybin-based depression therapy by 9 to 12 months, sending its shares nearly 6% higher.

Following a positive meeting with the U.S. Food and Drug Administration, Compass plans for a rolling submission, providing trial results as they are completed, and the agency to review them upon receipt.

The usual process involves companies submitting its entire application at once.

CONTEXT

The experimental therapy, COMP360, is based on the psychedelic compound, psilocybin, and is designed as a short-term, episodic alternative to daily antidepressants. It is being tested in patients with treatment-resistant depression.

In June, data from a late-stage study showed the therapy reduced the severity of depression symptoms, but fell short of market expectations. Wall Street analysts, however, said the data indicated that COMP360 might get approved.

WHY IT’S IMPORTANT

The fast-growing market for psychedelic-based treatments for psychiatric conditions could be worth up to $50 billion, according to analysts.

Atai Life Sciences, Cybin and MindMed are among other companies developing psychedelic-based treatments for psychiatric conditions.

KEY QUOTE

This is evidence of the supportive regulatory environment for the development of psychedelics for mental health conditions, which should benefit companies like Atai, Berenberg analyst Harry Gillis said.

The trial results next year “are important longer term as we expect this market to eventually become competitive”, said BTIG analyst Thomas Shrader.

WHAT’S NEXT

Compass plans to announce 9-week data and 26-week data from two separate late-stage studies testing COMP360 next year.

The company is also testing the drug as a treatment option for post-traumatic stress disorder.

(Reporting by Sneha S K in Bengaluru; Editing by Vijay Kishore)