Lykos Therapeutics Announces New Initiatives and Measures for Additional Oversight for Midomafetamine-Assisted Therapy, if FDA Approved

• Company launching independent advisory board to inform key elements of a potential commercial launch, including therapy training, ethics and healthcare integration
• Company plans to work with select top-tier behavioral health centers that can meet FDA-proposed patient monitoring requirements and provide integrated quality care
• Company will collaborate with other institutions around therapy training

SAN JOSE, Calif., Aug. 1, 2024 /PRNewswire/ -- Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced new initiatives and measures for additional oversight for midomafetamine capsules in combination with psychological intervention ("midomafetamine-assisted therapy") for the treatment of post-traumatic stress disorder ("PTSD") in adults, if approved by the U.S. Food and Drug Administration ("FDA"). The new drug application ("NDA") included results from numerous studies, including two randomized, double-blind, placebo-controlled Phase 3 studies (MAPP1 and MAPP2) evaluating the efficacy and safety of midomafetamine-assisted therapy versus placebo with therapy in participants diagnosed with moderate or moderate and severe PTSD, respectively. Both MAPP1 and MAPP2 studies met their primary and secondary endpoints and were published in Nature Medicine.^1,2

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Lykos' NDA is the first to combine a drug and psychological intervention. While not regulated by the FDA, the practice of psychotherapy is already a regulated field with mandatory reporting requirements and oversight provided by licensing boards and professional societies. The healthcare professionals providing psychological intervention with midomafetamine, if approved, will utilize their clinical judgment to effectively deliver treatment, with appropriate oversight from these governing bodies. This will be in addition to controls and requirements set forth in the product labeling and the Risk Evaluation and Mitigation Strategy ("REMS") program.

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"Given the novelty of this approach, we are taking steps to help ensure additional oversight for this drug plus therapy modality, if FDA approved, and to help integrate into the real-world healthcare setting," said Amy Emerson, Chief Executive Officer at Lykos Therapeutics. "It is critical for the millions of people suffering with PTSD, including veterans and survivors of physical and sexual assault, to have access to a potential new treatment option. To this end, we will work with external experts on an independent advisory board, focus our initial commercial rollout on centers of care where there are multiple layers of oversight and collaborate with others around therapy training. This process will establish a strong foundation to ultimately reach more patients in need of access to new treatment options."

The new initiatives and measures of additional oversight include:

• Establishing an independent advisory board comprised of external experts in corporate and medical ethics, innovation, psychiatry, and military and veteran health to inform the Company's plans for the potential commercial launch of midomafetamine, if approved by the FDA. Advisory Board Members will include Barbara O. Rothbaum, Ph.D., Professor of Psychiatry, Emory University School of Medicine, Brigadier General (Ret) Loree Sutton, M.D., the highest-ranking psychiatrist to serve in the U.S. Army for twenty years who was awarded the Bronze Star, Robert Chesnut, former Assistant U.S. Attorney and author of the book "Intentional Integrity: How Smart Companies Can Lead an Ethical Revolution," and others.
• Working with top behavioral health facilities to help ensure these sites are prepared to implement the measures utilized in Lykos' clinical trials. Midomafetamine, if approved, would only be commercially available at centers of care that meet all the FDA and Drug Enforcement Administration ("DEA") requirements, such as nationally accredited centers, veteran healthcare facilities and academic medical centers that have coordinated medical and behavioral health care and layers of oversight. The REMS program will ensure the drug is administered only in certified healthcare facilities that meet the FDA's proposed requirements. Emory University, Sheppard Pratt, Hackensack Meridian Health, Pacific Neuroscience Institute and Sunstone Therapies are some of the centers that plan to be among the first to deliver midomafetamine-assisted therapy, if approved by the FDA.
• Collaborating on training to leverage Lykos' clinical trial experience developing MDMA-assisted therapy combined with the external perspective of institutions and health systems, if approved. Lykos is in dialogue with others on how to begin transitioning training to appropriately support the needs of institutions planning to deliver this new investigational treatment. The independent Advisory Board that we are establishing will advise on the approach to therapist training and how it can be delivered, including opportunities to transfer to others.

"PTSD patients deserve the most effective treatments we can offer, and we want to make sure that we are well positioned to meet their needs," said Dr. Rothbaum. "Given the promise of midomafetamine-assisted therapy, we have been preparing our center to be an early leader in this potential science-driven combination treatment."

Midomafetamine capsules have not been approved by any regulatory agency. The safety and efficacy of midomafetamine have not been established for the treatment of PTSD. Investigational midomafetamine is also being studied in other indications. If approved, the FDA will require a REMS program, which is generally designed to prevent, monitor and/or manage a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event.

About PTSD Prevalence and symptomsPTSD is a serious mental health condition that can develop when a person experiences or witnesses a traumatic event.⁴ PTSD affects approximately 13 million Americans each year with women and disadvantaged or marginalized groups more likely to be affected.^1,2 Military personnel also have a greater prevalence of PTSD than the general population.³ However, it may not be as widely known that the largest cause of PTSD is non-combat-related trauma (e.g., sexual violence, unexpected death of a loved one, life-threatening traumatic event or interpersonal violence).⁴ PTSD results in debilitating symptoms, including nightmares and intrusive thoughts related to the trauma, mental and/or physical distress in response to trauma-related stimuli, avoidant behaviors, negative thoughts and feelings, and hyperarousal.⁵ These symptoms can impact nearly all aspects of a person's life, including their interpersonal relationships.⁴ PTSD can also be a chronic condition, with a World Health Organization study showing that after ten years post-trauma, nearly a quarter of people had not recovered.⁶

Co-morbidities and economic impactPeople with PTSD frequently experience anxiety, depression, substance use disorder and suicidal ideation.^7,8 They may also have a greater incidence of medical conditions that impact their physical health, including heart disease, metabolic syndrome and asthma.^9,10,11,12 U.S. Army Veterans who developed PTSD after military service have been shown to have an approximately two times greater risk of mortality than U.S. Army Veterans who did not develop PTSD after military service.¹⁵ In addition to the significant personal impact, PTSD has an enormous economic impact, resulting in an estimated annual cost of over $232 billion in the United States.¹³

PTSD treatmentTrauma-focused talk therapy, which concentrates on memories of the traumatic event or thoughts and feelings associated with the traumatic event, is first-line treatment for PTSD, which can be used alone or in combination with medication. ¹⁴ There are two SSRIs approved for the treatment of PTSD—sertraline and paroxetine.¹⁵ Studies have shown that talk therapy lessens the severity of PTSD symptoms, however, improvements in functioning and quality of life have been modest.^16,17 Trauma-focused talk therapy is associated with a high risk of dropout and lingering symptoms, which occur in as many as two-thirds of people who complete treatment.^18,19 Current treatments for PTSD are "reasonably efficacious"⁵, however, many people don't respond to treatment or stop treatment early, underscoring the urgent need for new evidence-based therapies and approaches to address this important public health issue.² While there have been advancements in the management of PTSD, there have been no new drug treatments for PTSD approved by the FDA in over 20 years.²⁰

About Midomafetamine-Assisted Therapy Midomafetamine (MDMA) is commonly known to mental health professionals. In the 1970s and early 1980s MDMA was used in conjunction with talk therapy by mental health providers to help enhance patients' access, processing and communication of difficult emotions and experiences.²¹ MDMA is an entactogen— a class of psychoactive compounds that are differentiated from classic psychedelics (i.e., psilocybin, mescaline and LSD) and are defined based on their mechanism and demonstrated effects of increasing self-awareness, leading to introspection and personal reflection.^22,23

In 1985, the DEA made MDMA a Schedule I drug under the Controlled Substances Act, preventing it from being used for recreational or medical use.²⁴ Since then, research has suggested that MDMA may have potential as a catalyst to support psychotherapy by helping diminish the brain's fear response, allowing people to access and process painful memories without being overwhelmed.²⁵

Lykos, with longstanding roots in advocacy for psychedelic medicine, was the first company to pioneer randomized, double-blind, placebo-controlled clinical trials evaluating the efficacy and safety of midomafetamine-assisted therapy as an investigational modality using midomafetamine in combination with psychological intervention. Lykos submitted an NDA to the FDA seeking approval of midomafetamine for the treatment of PTSD in adults. If approved by the FDA, the DEA would be required to reschedule midomafetamine to make it available for prescription medical use.

Lykos Therapeutics At Lykos, a public benefit corporation (PBC) founded by the Multidisciplinary Association for Psychedelic Studies ("MAPS"), our mission is to transform mental healthcare. We're applying decades of evidence-based research to develop investigational psychedelics to catalyze therapeutic approaches for mental health conditions. We are relentlessly exploring and reimagining novel approaches to address unmet needs in the mental healthcare space, with an initial focus on PTSD. As a PBC, we are focused on making a positive impact on our people, communities and society. To learn more, visit us at www.lykospbc.com and on LinkedIn, X, Instagram and Facebook.

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¹ VA National Center for PTSD. US Department of Veterans Affairs. https://www.ptsd.va.gov/understand/common/common_adults.asp Accessed May 13, 2024.² Goldstein RB et al. The epidemiology of DSM-5 posttraumatic stress disorder in the United States: results from the National Epidemiologic Survey on Alcohol and Related Conditions-III. Soc Psychiatry Psychiatr Epidemiol. 2016; 51(8):1137–1148.³ Lehavot K et al. Post-traumatic stress disorder by gender and veteran status. Am J Prev Med. 2018 Jan;54(1):e1-e9. doi: 10.1016/j.amepre.2017.09.008⁴ American Psychiatric Association. (2022). Diagnostic and statistical manual of mental disorders (5th ed., text rev.). https://doi.org/10.1176/appi.books.9780890425787⁵ Bryant RA. Post-traumatic stress disorder: a state-of-the-art review of evidence and challenges. World Psychiatry. 2019;18(3):259–269.⁶ Rosellini AJ et al. Recovery from DSM-IV post-traumatic stress disorder in the WHO World Mental Health surveys. Psychol Med. 2018 Feb;48(3):437-450. doi: 10.1017/S0033291717001817⁷ Grinage B.D. Diagnosis and management of post-traumatic stress disorder. Am Fam Physician. (2003);68(12):2401-2409. PMID: 14705759.⁸ Rojas SM et al. Understanding PTSD comorbidity and suicidal behavior: associations among histories of alcohol dependence, major depressive disorder, and suicidal ideation and attempts. J Anxiety Disord. 2014 Apr;28(3):318-25. doi: 10.1016/j.janxdis.2014.02.004⁹ Edmondson D, von Känel R. Post-traumatic stress disorder and cardiovascular disease. Lancet Psychiatry. 2017 Apr;4(4):320-329. doi: 10.1016/S2215-0366(16)30377-7¹⁰ Krantz DS, Shank LM, Goodie JL. Post-traumatic stress disorder (PTSD) as a systemic disorder: Pathways to cardiovascular disease. Health Psychol. 2022 Oct;41(10):651-662. doi: 10.1037/hea0001127¹¹ Boscarino JA. Posttraumatic stress disorder and mortality among U.S. Army veterans 30 years after military service. Ann Epidemiol. 2006 Apr;16(4):248-56. doi: 10.1016/j.annepidem.2005.03.009¹² Nichter B, Norman S, Haller M, Pietrzak RH. Physical health burden of PTSD, depression, and their comorbidity in the U.S. veteran population: Morbidity, functioning, and disability. J Psychosom Res. 2019 Sep;124:109744. doi: 10.1016/j.jpsychores.2019.109744¹³ Davis LL. The economic burden of posttraumatic stress disorder in the United States from a societal perspective. J Clin Psychiatry. (2022) Apr 25;83(3):21m14116. doi: 10.4088/JCP.21m14116¹⁴ Watkins LE, Sprang KR, Rothbaum BO. Treating PTSD: A Review of Evidence-Based Psychotherapy Interventions. Front Behav Neurosci. 2018 Nov 2;12:258. doi: 10.3389/fnbeh.2018.00258. PMID: 30450043; PMCID: PMC6224348.¹⁵ Schlenger WE, Corry NH, Williams CS, et al. A prospective study of mortality and trauma-related risk factors among a nationally representative sample of Vietnam Veterans. Am J Epidemiol. 2015;182 (12):980–990. https://doi.org/10.1093/aje/kwv217¹⁶ Cusack K, et al. Psychological treatments for adults with posttraumatic stress disorder: A systematic review and meta-analysis. Clin Psychol Rev. 2016;43:128-141.¹⁷ Bonfils, KA et al, Functional outcomes from psychotherapy for people with posttraumatic stress disorder: A meta-analysis. J Anxiety Disorders. 2022;89:102576.¹⁸ Lewis, C., Roberts, N. P., Gibson, S., & Bisson, J. I. (2020). Dropout from psychological therapies for post-traumatic stress disorder (PTSD) in adults: systematic review and meta-analysis. European Journal of Psychotraumatology, 11(1). https://doi.org/10.1080/20008198.2019.1709709¹⁹ Steenkamp, M. M., Litz, B. T., Hoge, C. W., & Marmar, C. R. (2015). Psychotherapy for Military-Related PTSD. JAMA, 314(5), 489. https://doi.org/10.1001/jama.2015.8370²⁰ Stein MB, Rothbaum BO. 175 Years of Progress in PTSD Therapeutics: Learning From the Past. Am J Psychiatry. 2018 Jun 1;175(6):508-516. doi: 10.1176/appi.ajp.2017.17080955²¹ Wagner MT, Mithoefer MC, Mithoefer AT, MacAulay RK, Jerome L, Yazar-Klosinski B, Doblin R. Therapeutic effect of increased openness: Investigating mechanism of action in MDMA-assisted psychotherapy. J Psychopharmacol. 2017 Aug;31(8):967-974. doi: 10.1177/0269881117711712²² Nichols, David E. Entactogens: How the name for a novel class of psychoactive agents originated. Frontiers in Psychiatry. 2022 Mar 25;13:863088. doi:10.3389/fpsyt.2022.863088²³ Vollenweider, Franz X.,Dialogues Clin Neurosci. 2001 Dec; 3(4): 265–279.doi: 10.31887/DCNS.2001.3.4/fxvollenweider²⁴ National Institute on Drug Abuse (NIDA) (nih.gov) What is the history of MDMA? . Accessed, January 17, 2024. What is the history of MDMA? | National Institute on Drug Abuse (NIDA) (nih.gov)²⁵ Yazar-Klosinski B, Mithoefer MC. Potential psychiatric uses for MDMA. Clinical Pharmacology & Therapeutics. 2017 Feb;101(2):194-196. doi: 10.1002/cpt.565

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