(Bloomberg) — Lykos Therapeutics Inc. said it was restructuring operations and cutting most of its staff less than a week after US regulators rejected its psychedelic drug MDMA for post-traumatic stress disorder.
The company said it plans to reduce its workforce by 75%, leaving only a small team focused on reversing the Food and Drug Administration’s decision. The privately held company appointed former Johnson & Johnson executive David Hough to oversee those efforts, including a clinical development program and engagement with the agency.
Hough, now a senior medical adviser at Lykos, was at J&J for more than 17 years, Lykos said in a statement. While there, he helped develop Spravato, the company’s nasal version of ketamine, used for treatment-resistant depression, it said.
Lykos said it aims to resubmit its MDMA for approval, though it didn’t offer an estimate for how long it would take. The company previously said the FDA asked it to conduct another phase 3 study, which typically takes several years to complete.
“As we prepare to address the FDA decision, we need to focus on delivering the FDA the robust clinical data necessary to support the approval of this potential new treatment,” Lykos Chief Executive Officer Amy Emerson said in the statement.
The FDA’s Aug. 9 rejection wasn’t a surprise. In June, a group of advisers voted against using MDMA to treat PTSD and said Lykos hadn’t proved the drug was effective. Panel members worried that patients could tell if they were getting MDMA instead of a placebo, and may have fared better as a result. They also cited limited information regarding adverse events and potential clinical trial misconduct.
Details of the rejection letter aren’t public. In an emailed statement following the decision, the agency said significant limitations in Lykos’ application prevented it from concluding that the drug was safe and effective.
Roughly 13 million Americans had PTSD in 2020, according to the Department of Veterans Affairs. There are few treatment options available, and those that are include two approved drugs that aren’t effective for many patients.
–With assistance from Bill Haubert.
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