Lykos co-founder Doblin to step down after MDMA setback

Lykos Therapeutics is slashing around 75% of its staff following the FDA's decision not to approve its MDMA-assisted therapy for post-traumatic stress disorder (PTSD) last week, with founder Rick Doblin also stepping down from the company's board.

The restructuring will create a team focused on "clinical development, medical affairs, and engagement with the FDA" as it tries to get its application for MDMA therapy midomafetamine back on track. The FDA has asked the company to complete a new phase 3 trial, which would introduce a considerable delay to the programme.

"Lykos is deeply dedicated to bringing midomafetamine to those suffering from PTSD and remains highly committed to this goal," said Jeff George, chairman of the company's board.

"At the same time, we take to heart the FDA's decision and the additional work we will need to do to bring this pioneering therapy to market," he added.

To that end, Lykos has hired pharma industry veteran, and former Johnson & Johnson executive, Dr David Hough as a senior medical advisor, tasked with overseeing the clinical development programme and FDA engagement for the resubmission of midomafetamine. A new independent advisory board will also support the process.

Hough has experience of the psychedelic end of pharma, having worked as compound development team leader for J&J's ketamine-derived Spravato (esketamine nasal spray), which was approved by the FDA in 2019 for treatment-resistant depression and the following year for people with major depressive disorder (MDD) and acute suicidal thoughts or behaviour.

"My hope is to build on the strong foundation Lykos has created and leverage my experience in the industry to ensure a productive ongoing dialogue with the FDA and oversee the clinical work that needs to be done to address the agency's questions," said Hough of his new role.

The latest move also separates the company from Doblin, a psychedelic therapy proponent and activist, who also founded the Multidisciplinary Association for Psychedelic Studies (MAPS) from which Lykos Therapeutics – formerly known as MAPS PBC – spun out a few years ago.

Shortly after the FDA's decision on the company's application, the journal Psychopharmacology retracted three articles on the therapy due to protocol violations and because some authors "did not fully declare a potential competing interest" – specifically, affiliation with MAPS PBC.

First formed in 1986, MAPS has the express purpose of working with the FDA and DEA to make MDMA-assisted talk therapy an approved tool to treat PTSD. Doblin said resigning from the Lykos board will allow him to work more closely with MAPS to that end.

George, meanwhile, said that Doblin has been a "trailblazer" in the psychedelics field, pointing to his "many decades of leadership, unparalleled dedication, and deep contributions [that] have shaped and guided the revival of psychedelic research and development."