The affiliate of the Multidisciplinary Association for Psychedelic Studies launched the fundraising effort to support its New Drug Application for an investigational, MDMA-assisted therapy for post-traumatic stress disorder.
Pictured: An illustration showing yellow dollar signs spiraling outward on a green background/iStock, Vectordivider
The MAPS Public Benefit Corporation announced on Friday that it has rebranded to Lykos Therapeutics after wrapping up a $100 million Series A funding round.
MAPS PBC was founded in 2014 as the pharmaceutical arm of the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS). At the time, it was a separate but wholly owned subsidiary, with its goal to eventually bring MDMA-assisted therapy for post-traumatic stress disorder (PTSD) through FDA approval and into commercialization.
The rebranding of the company to Lykos reflects the company’s “new stage of focus—the integration of the potential first psychedelic-assisted therapy into the healthcare system if approved by FDA,” the company said in a release. The company submitted an NDA to the FDA for its MDMA-assisted PTSD therapy last month.
The $100 million in contributions from its fundraisers and undisclosed sum of convertible notes, led by Helena, “comes at this critical time as we are transitioning from a development-stage company to one focused on commercialization of the potential first psychedelic-assisted therapy,” Lykos CEO Amy Emerson said in the company’s announcement. Protik Basu, managing partner at Helena, added that the “strong funding round, combined with the Phase III results and recent new drug application submission to the FDA, position Lykos to continue its journey to help transform mental health,” pending approval of its NDA.
That NDA has been a work in progress for some time. The company’s proposed MDMA-assisted therapy is an investigational modality combining the drug itself, commonly known as ecstasy, with “psychological intervention and other supportive services to treat PTSD.” Lykos has already completed two Phase III trials evaluating the safety and efficacy of its treatment against placebo. Both trials met their primary and secondary endpoints, and this round of funding will “help enable Lykos to finish regulatory and pre-launch activities,” the company said in the release.
Lead investigator Jennifer Mitchell previously told BioSpace that it has long been clear to her that psychedelics hold therapeutic potential, despite long-standing opposition from regulatory agencies. She approached the FDA in the 1990s to suggest giving psilocybin, the active ingredient in magic mushrooms, to men suffering from depression after the AIDS crisis, and was “laughed out of the building,” she said. Nevertheless, the movement toward FDA approval of the MDMA-assisted treatment “feels great,” she added.
Those efforts got a shot in the arm in 2017, when the FDA granted MDMA a Breakthrough Therapy designation. On that basis, Lykos has requested Priority Review of its therapy from the FDA. The FDA has 60 days from January 5 to determine whether the NDA will be accepted for review, and whether that review will be expedited.
If approved, the therapy would be the first MDMA-assisted therapy given the green light in the United States, and would require the Drug Enforcement Agency (DEA) to reschedule MDMA to make it legal for prescription use. It would not, however, be the first country to approve prescription use of MDMA: that would be Australia, which did so in July 2023.
Mordor Intelligence, an industry analysis company, said psychedelic investment increased nearly 10-fold from 2019 to 2020, going as high as $615 million. In 2021, investment surpassed that high-water mark within three months.
Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at lynchjourno@gmail.com.
Correction (Jan. 10): This story has been updated to correctly state that while MAPS is nonprofit, MAPS PBC is for profit. BioSpace regrets the error.
