As interest in psychedelic therapies ramp up, Lykos Therapeutics will go in front of the FDA’s Psychopharmacologic Drugs Advisory Committee on June 4 to present its investigational treatment for post-traumatic stress disorder.
Lykos Therapeutics’ investigational midomafetamine capsules, which the biotech is proposing as a treatment for post-traumatic stress disorder, is slated to come under the scrutiny of the FDA’s Psychopharmacologic Drugs Advisory Committee.
The meeting of external experts, which is scheduled for June 4, 2024, will be the first advisory committee session convened for a potential new post-traumatic stress disorder (PTSD) therapy in 25 years, according to the biotech’s press release.
Lykos’ drug application will also be the “first MDMA-assisted therapy and psychedelic-assisted therapy to be reviewed by the Psychopharmacologic Drugs Advisory Committee,” CEO Amy Emerson said in a statement, calling the meeting and the investigational therapy a “significant milestone in the field of psychedelic medicine.”
MDMA, scientifically known as 3,4-methylenedioxymethamphetamine but colloquially called ecstasy—belongs to a class of psychoactive compounds called entactogens, which have the effect of increasing their users’ self-awareness and introspection. MDMA is a Schedule I drug, limiting its recreational and medical use.
Lykos is proposing to use MDMA tablets, in conjunction with psychotherapy and other supportive mental health services, as a treatment for adults with PTSD. Its New Drug Application, which the FDA accepted in February 2024, is backed by data from several studies including the Phase III MAPP1 and MAPP2 trials.
Both late-stage trials evaluated the Lykos’ MDMA-assisted therapy using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), the gold standard in PTSD symptom assessment. Key secondary endpoints for both trials also included functional improvement.
Results from MAPP1, which focused on patients with severe PTSD, showed a “significant and robust attenuation” in CAPS-5 scores versus placebo, according to a 2021 publication in Nature Medicine. The MDMA-assisted regimen also led to a significant improvement on the Sheehan Disability Scale, which quantifies functional ability.
MAPP2, which enrolled patients with moderate-to-severe disease, showed similar outcomes. CAPS-5 scores improved significantly compared to placebo, as did patients’ functional performance.
Both studies also revealed an overall favorable tolerability profile for the MDMA-assisted therapy, with no deaths and serious adverse events associated with the investigational treatment.
The FDA’s verdict is due on August 11, 2024.
Lykos’ adcomm meeting comes as psychedelics are poised to break into the biopharma industry’s mainstream. Last week, Novo-backed Reunion Neuroscience raised $103 million in a Series A financing round to advance its psilocybin-derivate therapy RE104 for postpartum depression.
In March 2024, MindMed’s LSD-based treatment MM120 (lysergide d-tartrate) won the FDA’s breakthrough designation on the back of positive Phase IIb data. A few weeks earlier, Incannex also reported strong Phase II data for its investigational psychedelic psilocybin drug candidate in generalized anxiety disorder.
In January 2024, the MAPS Public Benefit Corporation rebranded as Lykos Therapeutics after raising $100 million in a Series A.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
