Nov 4 (Reuters) - Drug developer Compass Pathways ( CMPS )
said on Tuesday it is pulling forward the expected
launch timing of its experimental psilocybin-based depression
therapy by 9 to 12 months.
The decision follows the completion of enrollment for a
late-stage study for the psychedelic-based therapy, COMP360, as
well as a positive meeting with the U.S. Food and Drug
Administration on strategies for its marketing application,
including a potential rolling submission.
CONTEXT
The experimental therapy called COMP360 is based on the
psychedelic compound called psilocybin and is designed as a
short-term, episodic alternative to daily antidepressants.
The company is testing the therapy in patients with
treatment-resistant depression, a condition in which patients do
not respond adequately to at least two different treatments.
In June, data from a late-stage study showed the therapy
reduced the severity of depression symptoms in a closely watched
study, 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.
Earlier this year, AbbVie ( ABBV ) said it would buy an
experimental psychedelic-based depression drug from Gilgamesh
Pharmaceuticals for up to $1.2 billion.
Atai Life Sciences ( ATAI ), Cybin and MindMed
are among other companies developing psychedelic-based
treatments for psychiatric conditions.
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.