Earlier this month, the FDA took Lykos Therapeutics from flying high to a bad trip.
On August 9, the FDA declined to approve Lykos’s MDMA therapy, and the drug company stated in a release the same day that the agency requested it conduct another Phase 3 trial to “study the safety and efficacy of midomafetamine [MDMA].” Lykos’s MDMA treatment was designed to help patients with post-traumatic stress disorder (PTSD) and other mental health conditions.
The decision, which came despite support from Congress, disappointed not just Lykos, formerly known as MAPS Public Benefit Corporation, but also advocates who were hoping for psychedelics to be approved.
“I was really disappointed, especially for the many PTSD sufferers who hoped the Lykos treatment would soon be available to them, but the decision wasn’t a total surprise,” Bob Jesse, who is an advisor for the UC Berkeley Center for the Science of Psychedelics, told Healthcare Brew in an email. “The FDA had tons of input to interpret, and depending on how they weighed various parts of it, they could probably have justified [any] approval, delay, or rejection.”
The FDA’s exact reasons have not been made public, but Lykos said in its release that it received the complete response letter (CRL) from the agency. The company declined to comment on the matter, though some experts say that the future of psychedelics remains strong.
Test subject. Seeing Lykos as the “first mover” in MDMA treatments, Ingmar Gorman, CEO and co-founder of psychedelic education company Fluence, told Healthcare Brew that the company will face the most “questions and challenges” on the road to approval, as MDMA treatments are new to the FDA approval process.
“I’m hopeful that Lykos will be able to overcome those challenges, and it’s also an opportunity for other companies in the space to be able to learn,” Gorman said.
Lykos said in a press release about the rejection that “the issues expressed in the CRL echo those raised during the FDA advisory committee meeting on June 4.”
The issues included concerns about testing patients with prior MDMA use because they may have had “expectancy bias” and therefore know if they were given the treatment versus a placebo. Additionally, Lykos said the FDA wants more information about the extent that psychotherapy benefits the MDMA treatment and whether it’s necessary.
In the release, Lykos announced that it plans to request a meeting with the FDA in order to ask the administration to reconsider its decision.
“While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the advisory committee meeting can be addressed with existing data, post-approval requirements, or through reference to the scientific literature,” Amy Emerson, CEO of Lykos, said in the release.
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A Phase 3 study, per the FDA’s website, is done to show whether a treatment benefits the population it intends to help. These are usually larger studies conducted over a longer period of time to also assess the safety of a product.
Bump in the road. After the FDA’s rejection, Lykos announced on August 15 it would lay off 75% of its staff, and that MAPS founder, Rick Doblin, would leave the board. Lykos appointed David Hough, who previously served as VP of research and development at J&J Innovative Medicine, to oversee clinical development and FDA engagement as the company resubmits its MDMA treatment.
Still, Gorman said that the company is just experiencing a “bump in the road.”
“It’s important to decrease one’s burn to be able to pivot and adapt to the circumstances,” Gorman said, adding that he expects Lykos will take the “most efficient steps” to get back to the FDA as soon as possible after the proposed meeting.
Trip ahead. Still, both Jesse and Gorman said that they remain hopeful about the future of psychedelics, despite the challenges Lykos has faced this month.
“There’s really no doubt that judicious, safeguarded use of psychedelics can bring a host of benefits, both medical and nonmedical. For sure, the substances are not risk-free, and they can lead to serious harms, yet on balance, I and many see them as amazing gifts,” Jesse said.
On the horizon, Gorman said that psilocybin, also known as psychedelic mushrooms, may also be getting closer to FDA approvals. He said that while it’s not clear which company will bring it forward, Compass Pathways, Usona, and Cybin are all contenders. Each has reported Phase 2 studies to treat mental health conditions. (Usona also started a Phase 3 trial last week.)
Over the last 50 years, Gorman said, researchers have had to overcome limitations around funding to study the clinical potential of psychedelics as well as stigma in academic and professional spheres. Ultimately, he sees this recent setback as par for the course.
“It’s not entirely surprising that there’s still a lack of knowledge about what this clinical trial was about,” he said. “I would say that this isn’t a reason for panic. It’s just part of the process.”