Lykos cutting most of staff less than a week after FDA rejection

Lykos Therapeutics is cutting 75% of its staff following the FDA’s rejection last week of its MDMA-assisted therapy, the company said Thursday.

Rick Doblin

Rick Doblin, founder and president of the organization that spun out the company, is leaving as well.

The cuts, which are expected to hit roles across the company, were first announced at an employee meeting on Thursday, according to a person familiar with the discussion. Lykos’ announcement confirming the cuts followed shortly and came after repeated attempts for comment that were declined by a company spokesperson.

The remaining employees will be focused on “ongoing clinical development, medical affairs and engagement with the FDA.”

David Hough

David Hough, a longtime Johnson & Johnson R&D executive who helped oversee the development of esketamine depression treatment Spravato, is replacing Doblin on the Lykos board. He left J&J in 2020.

The cuts are the latest blow to a startup in turmoil after the FDA rejected its treatment for post-traumatic stress disorder on Aug. 9.

The FDA said that the company needs to conduct another Phase 3 trial, a task that would take “several years,” CEO Amy Emerson previously said. She told Endpoints News in late July that she anticipated continuing to fundraise to support the company, but that needing a new trial would be “a different circumstance for raising money.”

Lykos’ FDA application was based on two positive Phase 3 studies showing that patients receiving the treatment had a statistically significant improvement in PTSD symptoms.

But the data from those trials came under scrutiny from outside experts at an FDA advisory committee meeting in June and the Institute for Clinical and Economic Review, a key US pricing group. Both groups were concerned by how many patients were able to correctly identify whether they were given MDMA or placebo, and they faulted Lykos for failing to collect data on whether patients had positive responses to the drug — like euphoria or enjoyment — that may have informed them of its potential for abuse.

Both groups resoundingly recommended against approving the MDMA-assisted therapy. The FDA said in a rare post-rejection statement that “there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication.” But the regulator also said it remains committed to advancing new PTSD treatments and psychedelic-based therapies.

“We will continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies to address these medical needs,” the agency said.

There are also bigger ethical questions — mainly raised by ICER — about whether patients felt pressured to report positive data given the historical significance of MDMA nearing the FDA’s desk. There was also a 2015 case of sexual misconduct alleged against a therapist and her unlicensed husband by a patient in one of the company’s Phase 2 trials.

Amy Emerson

In an interview ahead of the FDA’s decision, Emerson defended the conduct of the company and its researchers.

“We ran a rigorous Phase 3 clinical trial with the proper compliance in place for this and we have a compliance program that has looked through all of our data,” she said. “I stand behind the rigor of the clinical trial and the way our data was collected.”

Editor’s note: This story was updated with additional details from Lykos’ press release.