AbbVie set to acquire Gilgamesh Pharmaceuticals’ Bretisilocin for major depressive disorder

AbbVie and Gilgamesh Pharmaceuticals have announced their definitive agreement under which AbbVie will acquire Gilgamesh’s lead investigational candidate, currently in clinical development for the treatment of patients with moderate-to-severe major depressive disorder.

Note that Psychedelic compounds have gained recognition as potential treatments for mental health disorders, such as MDD, because of their demonstrated rapid, robust and durable antidepressant effects. However, existing agents in this class are hampered by their long duration of psychoactive experience.

In addition, the positive topline results from a Phase 2a study of bretisilocin in MDD were recently announced, demonstrating a clinically impactful and statistically significant reduction in severity of depressive symptoms versus low dose active comparator, as measured by the Montgomery-Åsberg Depression Rating Scale total score. At Day 14, a single dose of bretisilocin demonstrated robust antidepressant effect with a -21.6 point change from baseline in MADRS total score compared to a -12.1 point change from baseline for the low dose active comparator. Bretisilocin was well tolerated with no serious adverse events.

“The field of psychiatry represents one of the most challenging areas in medicine, with a significant need for innovative solutions,” said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “This acquisition underscores our commitment to broadening and enhancing psychiatric care by investing in novel treatment approaches with the potential to reach patients for whom other treatments have been ineffective. We look forward to advancing bretisilocin to late-stage clinical development.”

“AbbVie’s leadership in neuroscience and commitment to advancing innovative treatments make them the ideal partner to advance bretisilocin rapidly forward while enabling Gilgamesh to continue pursuing our broader mission of developing novel, transformative therapies for complex mental health and neurological conditions,” said Jonathan Sporn, M.D., chief executive officer at Gilgamesh Pharmaceuticals.

 

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AbbVie, Bretisilocin, Gilgamesh Pharmaceuticals