Lykos Therapeutics (Formerly MAPS PBC) Announces Publication Examining the Effects of MDMA-Assisted Therapy on Emotional Coping Skills and Self-Experience in PTSD

• Participants with severe PTSD who received MDMA-assisted therapy demonstrated significant improvements in self-experience
• Improvements in self-compassion associated with MDMA-assisted therapy were independent of PTSD symptom improvement

SAN JOSE, Calif., Jan. 10, 2024 /PRNewswire/ -- Lykos Therapeutics (formerly MAPS Public Benefit Corporation) (“Lykos”), a company dedicated to transforming mental healthcare, announced that PLOS ONE has published the first comparison of the effects of investigational MDMA-assisted therapy and therapy with placebo on emotional coping skills and self-experience in adults with severe post-traumatic stress disorder (“PTSD”). The study explored how changes in self-experience impacted PTSD scores in the Company’s Phase 3, randomized, double-blind, placebo-controlled study (MAPP1), previously published in Nature Medicine. Results showed that compared to therapy with placebo, MDMA-assisted therapy participants had a statistically significant greater improvement in all self-experience measures.

“People who have histories of having been traumatized as children within their caregiving systems are particularly prone to developing major deficits in emotion regulation and often develop a self-identity of being worthless and defective,” said Bessel van der Kolk, M.D., Phase 3 investigator, president of the Trauma Research Foundation and author of The Body Keeps the Score.¹ “When these people are being treated for their PTSD, their lack of a sense of safety and difficulties with trust can be major obstacles to successful completion of treatment; these deficits often prevent treatment from being successful. In this study, we observed that MDMA-assisted therapy was more effective than psychotherapy alone in improving a range of problems with self-experience that are associated with treatment failure.”

Trauma-focused talk therapy is considered a first-line treatment for PTSD, however the success rates with treatment have been limited by several factors.^2,3 At least a quarter of patients drop out of treatment, up to one-half are left with lingering symptoms,^4,5,6 and even those who respond to treatment often experience lingering challenges with emotional regulation, impulse control and interpersonal functioning.^7,8,9 As multiple studies have shown that reduced self-capacities interfere with successful completion of talk therapy for PTSD, the goal of this analysis was to assess if MDMA-assisted therapy or therapy with placebo had a significant impact on validated measures of self-experience.

Study Design
This publication reports results from three transdiagnostic outcome measures from the Company’s MAPP1 Phase 3 study, a randomized, double-blind, placebo-controlled trial comparing the safety and efficacy of investigational MDMA-assisted therapy to therapy with placebo in participants with severe PTSD. Full eligibility criteria are described in the study protocol. The analysis included 82 of 90 participants with data on self-experience measures who were randomized and completed at least one investigational treatment session (MDMA-assisted therapy = 42, therapy with placebo = 40). The majority of participants were women (53 of 82; 64.6%), White (65 of 81; 80.3%), non-Hispanic or Latino (76 of 82; 92.7%), college graduates (57 of 82; 69.5%) and, among 82 participants, the mean age was 41.42 years. Sixty-nine of 82 (84.2%) participants had histories of developmental trauma (e.g., childhood physical/sexual abuse) and 74 of 82 participants (90.2%) had suffered multiple traumas.

Each investigational treatment cycle consisted of one medication session and three integration sessions. During the medication sessions, a patient self-administered MDMA or placebo under the supervision of at least one qualified healthcare provider who provided therapy and other supportive services. This was followed by three integration therapy sessions to process what was uncovered. Prior to the 12 weeks, there were three preparation sessions. Therapy was conducted in accordance with the MDMA-assisted therapy treatment manual.

Study Results

Three validated, self-reported measures were used for this study:

• The Inventory of Altered Self Capacities (“IASC”) measures an individual’s psychological functioning and has been frequently used in treatment outcome studies of PTSD to measure difficulties with relationships, identity and emotional regulation.
• The Toronto Alexithymia Scale (“TAS-20") measures difficulties with recognizing and verbalizing emotions including difficulty describing feelings, difficulty identifying feelings and externally oriented thinking.
• The Self-Compassion Scale (“SCS”) assesses how respondents perceive their own failings, suffering or inadequacies with kindness and compassion.

MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.

Results suggest that investigational MDMA-assisted therapy had a stronger effect on measures of emotional regulation and self-experience and statistically significant greater improvements for almost all self-experience measures compared to the therapy with placebo group. Participants in the MDMA-assisted therapy group also had greater improvements on alexithymia (being in touch with oneself), self-compassion, and most other factors of self-experience than participants in the placebo group.

“In studies of healthy volunteers, MDMA has been associated with feelings of emotional communion, oneness and relatedness, but it is important to assess if those results translate to patients with PTSD,” said Amy Emerson, chief executive officer of Lykos Therapeutics. “This is the first analysis to show that the effects of MDMA on self-experience and compassion are seen in patients with PTSD when administered in conjunction with therapy.”

About MDMA-Assisted Therapy
MDMA-assisted therapy is an investigational modality being studied using a combination of MDMA (midomafetamine capsules), psychological intervention (talk therapy) and other supportive services to treat PTSD. MDMA (3,4-methylenedioxy-methamphetamine) is an entactogen— a class of psychoactive compounds that are differentiated from classic psychedelics and are defined based on their mechanism and known effects of increasing self-awareness leading to introspection and personal reflection.^10,11 Lykos has completed two Phase 3 trials for PTSD and submitted a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for MDMA used in combination with psychological intervention, which includes talk therapy, and other supportive services provided by a qualified healthcare provider. If approved by the FDA, investigational MDMA-assisted therapy would be the first psychedelic-assisted therapy approved for PTSD.

With Breakthrough Therapy designation given to MDMA in 2017, Lykos has requested the FDA grant Priority Review of the NDA. The FDA has 60 days to determine whether the NDA will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively). If approved by the FDA, the U.S. Drug Enforcement Administration (“DEA”) would be required to reschedule MDMA making it available for prescription medical use.

Lykos Therapeutics (Formerly MAPS PBC)
At Lykos, formerly MAPS PBC, our mission is to transform mental healthcare. We aspire to challenge the status quo through the development of novel therapies and therapeutic approaches to treat mental health conditions. With 30+ years of experience researching psychedelic-assisted therapies, we remain committed to the rigorous pursuit of evidence-based development of novel approaches. Founded in 2014 by the non-profit MAPS, Lykos Therapeutics is a for-profit public benefit corporation (“PBC”) established to further the development of investigational psychedelic-assisted therapies. As a PBC, we consider the impact of our decisions on society just as we think about financial implications. Everything we do is viewed through a public benefit lens. To learn more visit us at www.lykospbc.com and on LinkedIn, X, Instagram and Facebook.

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¹⁰ Nichols, David E.Entactogens: How the Name for a Novel Class of Psychoactive Agents Originated. Frontiers in Psychiatry. Vol 13, 2022. DOI= 10.3389/fpsyt.2022.863088.
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