Lykos CEO steps down following FDA rejection of MDMA therapy

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Lykos CEO steps down following FDA rejection of MDMA therapy
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Amy Emerson, CEO of Lykos Therapeutics, is stepping down less than a month after the FDA rejected the drugmaker’s psychedelic therapy, the company announced on Thursday.

Lykos developed an MDMA-based therapy designed to treat post-traumatic stress disorder (PTSD), which if it had been approved, would have been the first new treatment for the disorder in more than 20 years. Patients would have received the drug during three eight-hour therapy sessions, three to five weeks apart, in addition to 12 drug-free therapy sessions.

Lykos executives didn’t specify in the release the reason behind Emerson’s departure, which also comes weeks after the company laid off 75% of its roughly 100-person staff and the company’s founder, Rick Doblin, left the board.

Emerson, who has led the company since its founding in 2014, will serve in a senior advisor role through the end of 2024 and as an observer on the company’s board, the news release stated.

“We founded Lykos with a deep belief in the need for innovation in mental health, and I am deeply grateful for the privilege of leading our efforts,” Emerson said in a statement. “While we are not at the finish line, the past decade of progress has been monumental.”

Michael Mullette, a pharma industry veteran who previously worked at both Sanofi and Moderna and who has been Lykos’s COO since early 2022, will serve as interim CEO.

Lykos also named David Hough, a psychiatrist and Johnson & Johnson veteran, as chief medical officer. He was previously appointed to oversee clinical development and FDA engagement and guide the company through the resubmission process. At Johnson & Johnson, Hough helped oversee Phase 3 development and approval of Spravato, the drugmaker’s ketamine-based depression treatment.

“Charting a path toward FDA approval will require seasoned leadership and expertise,” Suprotik Basu, Lykos board director and a managing partner at Helena, Lykos’s lead investor, said in the release. “I’ve gotten to know both Mike and Dave over the past year, and I have deep conviction in their ability and commitment to bringing this treatment, if approved, to the millions who are waiting with great hope.”

Looking back: After the FDA rejected Lykos’s MDMA application in August, the agency requested the company run another Phase 3 trial to “study the safety and efficacy of midomafetamine [MDMA],” according to a release from the drug company.

The agency’s decision to reject the treatment came despite two bipartisan letters from 80 members of Congress urging President Joe Biden, FDA Commissioner Robert Califf, and other top government officials to approve the therapy.

The lawmakers claimed that existing PTSD treatments (e.g., selective serotonin reuptake inhibitors, or SSRIs, like Paxil and Zoloft) haven’t effectively decreased the number of annual veteran suicides, and stressed the importance of finding new therapeutic options.

Lykos’s MDMA therapy is “one of the most promising and available options” to treat PTSD, the Senate letter read.

Lykos declined Healthcare Brew’s request for additional comment on the matter.

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