By Christy Santhosh
(Reuters) -Lykos Therapeutics will lay off 75% of its workforce, or about 100 employees, and founder Rick Doblin will leave the board, the company said on Thursday, days after the U.S. FDA declined approval for its MDMA-based PTSD treatment.
Lykos, formerly known as MAPS Public Benefit Corp, said it was bringing in David Hough, former vice president for research and development at Johnson & Johnson (NYSE:), to lead and oversee clinical development of the MDMA capsules.
Hough spearheaded the development of J&J’s nasal spray, Spravato, used to treat depression in combination with an oral drug.
He joins Lykos days after the U.S. Food and Drug Administration declined to approve its midomafetamine-, or MDMA-based treatment for post-traumatic stress disorder, citing limited data.
Commonly known as ecstasy or molly, MDMA has long been seen by advocates as a potential treatment for mental health disorders.
The regulator’s decision was in line with the recommendations of its advisers, who flagged problems with the trial design and a lack of documentation around whether participants had abused the experimental drug.
The company said it planned to ask the FDA to reconsider its decision and would attempt a resubmission to seek approval for the MDMA capsules.
Jeff George, chairman of the Lykos board, said Hough was “the right person” to lead the crucial work of engaging with the FDA for the resubmission.
Doblin said he would continue to advocate for global access to MDMA, adding that resigning from the company’s board allowed him to speak freely.
“This change allows Rick Doblin to focus on the broader work of MAPS and Lykos to keep a narrow focus on doing the clinical and regulatory work,” Lykos told Reuters.
The company said the remaining 25% of its workforce would focus on developing the MDMA-based capsules and engaging with the FDA about next steps in the resubmission process.
