– Pharmaceutical industry veteran and former Janssen executive Dr. David Hough appointed senior medical advisor to oversee clinical and regulatory
– Lykos to significantly reduce workforce, streamlining organization around clinical development and regulatory engagement
– MAPS founder Dr. Rick Doblin to exit from Lykos Board
SAN JOSE, Calif., Aug. 15, 2024 /PRNewswire/ — Lykos Therapeutics (“Lykos”), a company dedicated to transforming mental healthcare, today announced a reorganization to best support the company as it works to address the resubmission of its new drug application (“NDA”) for midomafetamine capsules for the treatment of post-traumatic stress disorder (“PTSD”) in adults.
“Lykos is deeply dedicated to bringing midomafetamine to those suffering from PTSD and remains highly committed to this goal,” said Jeff George, Chairman of the Lykos Board. “At the same time, we take to heart the FDA’s decision and the additional work we will need to do to bring this pioneering therapy to market.”
As part of the changes, Dr. David Hough will lead and oversee the clinical development program and FDA engagement regarding the resubmission of midomafetamine. Dr. Hough previously was Vice President of Research and Development at J&J Innovative Medicine (a Johnson & Johnson company). He served in various leadership roles over 17 years, including as the compound development team leader for INVEGA (paliperidone), INVEGA SUSTENNA, INVEGA TRINZA, as well as the compound development team leader for SPRAVATO® (esketamine nasal spray), a position in which he was responsible for all medical, scientific, manufacturing, quality, preclinical, and commercial aspects of the program.
“My hope is to build on the strong foundation Lykos has created and leverage my experience in the industry to ensure a productive ongoing dialogue with the FDA and oversee the clinical work that needs to be done to address the Agency’s questions which will allow us to serve patients safely and effectively,” said Dr. Hough.
“Dr. Hough is a consummate industry professional and exactly the right person to lead the crucial work of engaging with the FDA for our resubmission,” added Mr. George. “His experience in recent approvals, including SPRAVATO®, is greatly relevant to our organization’s mission. We are grateful that he will join our team and we look forward to engaging the FDA in the coming months to work to bring this therapy to the millions of those suffering from post-traumatic stress disorder (PTSD).”
In addition, the company will be reducing its workforce by approximately 75%, with the remaining team focused on its ongoing clinical development, medical affairs, and engagement with the FDA.
“The team at Lykos has been part of a pioneering effort to bring forward the first clinical trials for midomafetamine and we are sincerely grateful for their efforts,” said Amy Emerson, Chief Executive Officer of Lykos. “As we prepare to address the FDA decision, we need to focus on delivering the FDA the robust clinical data necessary to support the approval of this potential new treatment.”
Lykos’ newly formed Independent Advisory Board will also provide overall support and guidance to the management team throughout the resubmission process and ensure continued engagement with top-tier behavioral health facilities, the mental health community, and key patient stakeholder groups such as veterans and survivors of sexual violence.
In addition, Dr. Rick Doblin, the Founder and President of MAPS, has left his position on the Lykos board.
“After 38 plus years of work, I’m profoundly saddened by the FDA decision around this critically needed therapy, but am heartened that Lykos will still move forward continuing clinical research that addresses the FDA’s questions,” said Dr. Doblin. “I can speak more freely as a public advocate by resigning from the Lykos Board. The FDA delays make it more important than ever that I work at MAPS toward developing global legal access to MDMA and other psychedelics for public benefit through MAPS’ multidisciplinary research, education, and drug policy reform.”
“Rick Doblin has been a trailblazing pioneer in this field,” said Mr. George. “His many decades of leadership, unparalleled dedication, and deep contributions have shaped and guided the revival of psychedelic research and development, spurring transformative innovation in mental health. His legacy will continue through the work of both Lykos and its peers as we all work towards providing new and better treatment options for millions of patients in need.”
Dr. Hough is a graduate of West Point and served for several years as an Army officer before attending medical school at the Uniformed Services University of the Health Sciences (USUHS) in Bethesda, Maryland. After completing residency training in Psychiatry at Walter Reed Medical Center in Washington DC, he served for 10 years as an Army psychiatrist at two separate community hospitals and on faculty at a psychiatry residency program in Honolulu, Hawaii. He supervised numerous psychiatry residents and allied mental health professionals serving as head of outpatient clinics and behavioral health departments in different military hospitals. He completed a two-year research fellowship in Clinical Pharmacology jointly sponsored by USUHS and Walter Reed Army Institute of Research. He is board certified in both Adult and Geriatric Psychiatry and held an Adjunct Assistant Professor of Psychiatry position at USUHS for several years. He has authored numerous publications in peer reviewed journals, is a reviewer for several journals, and was an examiner for the American Board of Psychiatry and Neurology. He served in various leadership roles over 17 years at J&J Innovative Medicine including as the compound development team leader for INVEGA (paliperidone), INVEGA SUSTENNA, INVEGA TRINZA, as well as the compound development team leader for SPRAVATO® (esketamine nasal spray), a position in which he was responsible for all medical, scientific, manufacturing, quality, preclinical, and commercial aspects of the program.
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.
About PTSD
Prevalence and symptoms
PTSD is a serious mental health condition that can develop when a person experiences or witnesses a traumatic event.1 PTSD affects approximately 13 million Americans each year with women and disadvantaged or marginalized groups more likely to be affected.2,3 Military personnel also have a greater prevalence of PTSD than the general population.4 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).5 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.6 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.7
Co-morbidities and economic impact
People with PTSD frequently experience anxiety, depression, substance use disorder and suicidal ideation.8,9 They also may have a greater incidence of medical conditions that impact their physical health, including heart disease, metabolic syndrome and asthma.10,11,12,13 U.S. Army veterans who developed PTSD after military service have been shown to have 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 treatment
Trauma-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 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” (Bryant, 2019, p.265), 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 approved by the FDA in over twenty 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 U.S. Drug Enforcement Administration (“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 MDMA-assisted therapy as an investigational modality using midomafetamine (MDMA) in combination with psychological intervention and submit an NDA to the FDA seeking approval for the treatment of PTSD in adults.
Lykos Therapeutics
At Lykos Therapeutics, 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 delivering positive impact on our people, communities and society. To learn more visit us at lykos pbc and on LinkedIn, X, Instagram and Facebook.
1 The Mayo Clinic, PTSD, symptoms and causes. Accessed February 14, 2024. www.mayoclinic.org/diseases-conditions/post-traumatic-stress-disorder/symptoms-causes/syc-20355967c
2 VA National Center for PTSD. US Department of Veterans Affairs. https://www.ptsd.va.gov/understand/common/common_adults.asp Accessed May 13, 2024.
3 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.
4 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.2017.09.008
5 Kessler RC, Rose S, Koenen KC, et al. How well can post-traumatic stress disorder be predicted from pre-trauma risk factors? An exploratory study in the WHO World Mental Health Surveys. World Psychiatry. 2014 Oct;13(3):265-74. doi: 10.1002/wps.20150
6 Bryant RA. Post-traumatic stress disorder: a state-of-the-art review of evidence and challenges. World Psychiatry. 2019;18(3):259–269.
7 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/S0033291717001817
8 Grinage B.D. Diagnosis and management of post-traumatic stress disorder. Am Fam Physician. (2003);68(12):2401-2409. PMID: 14705759.
9 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.2014.02.004
10 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)30377-7
11 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/hea0001127
12 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.2005.03.009
13 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.2019.109744
14 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 American Psychological Association. Clinical Practice Guidelines for the Treatment of PTSD. Medications (apa.org) Accessed May 17, 2024.
16 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/10.1080/20008198.2019.1709709
19 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.2015.8370
20 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.2017.17080955
21 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: 10.1177/0269881117711712
22 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.2022.863088
23 Vollenweider, Franz X.,Dialogues Clin Neurosci. 2001 Dec; 3(4): 265–279.doi: 10.31887/DCNS.2001.3.4/fxvollenweider
24 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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