Paliperidone Palmitate

Amy Emerson, Lykos' founding leader, stepping down as CEO Pharma veteran and Lykos Chief Operating Officer Michael Mullette appointed as interim CEO Dr. David Hough named Chief Medical Officer SAN JOSE, Calif., Sept. 5, 2024 /PRNewswire/ -- Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, today announced key changes to the company's senior management. Amy Emerson, who has led Lykos for the past decade since its founding in 2014, will step down as Chief Executive Officer ("CEO"). She will transition into a senior advisor role through the end of the year and will serve as an Observer on the Lykos Board. Michael Mullette, who has served as Chief Operating Officer ("COO") since early 2022 following over two decades with Sanofi and Moderna, will become the company's interim CEO. "Mike is a highly experienced leader with the right background and skills to steer Lykos as we engage with the FDA and work to bring this pioneering treatment to patients in need," said Jeff George, Chairman of the Lykos Board of Directors. "Mike has been highly impactful in his role as COO and has a deep understanding of the path ahead. He brings a wealth of knowledge and an impressive track record from over two decades in pharmaceuticals and is well-equipped to lead Lykos as we look to the future." Mr. Mullette joined Lykos after more than two decades in the pharmaceutical industry, most recently heading North America for Moderna, where he oversaw commercialization of the company's COVID-19 vaccine during the height of the pandemic. Prior to this, he spent nearly 20 years with Sanofi, where he held management and leadership roles across the U.S., France, Japan, Australia, and Canada, including as GM and Country Chair of Sanofi Canada and as GM of Sanofi Pasteur in Japan. Amy Emerson departs her role at Lykos after nearly 10 years. She began work on the midomafetamine program in 2003 and was appointed to lead Lykos (then MAPS PBC) upon its formation in 2014. "We founded Lykos with a deep belief in the need for innovation in mental health, and I am deeply grateful for the privilege of leading our efforts," said Ms. Emerson. "While we are not at the finish line, the past decade of progress has been monumental. Mike has been an outstanding partner and is well prepared to step in and lead our next steps. I know he will continue to pursue Lykos' mission of helping patients with unwavering dedication and resolve." "Amy's contributions to Lykos, and to innovation in the field of mental healthcare more broadly, cannot be overstated," Mr. George added. "She has helped pioneer the pathway for this FDA-designated breakthrough therapy program since its infancy. We are deeply grateful for her leadership and service." In addition to Mr. Mullette's appointment, Dr. David Hough, who was recently announced as Lykos' senior medical advisor, formally joins the company as Chief Medical Officer. In his expanded role, Dr. Hough will continue to oversee Lykos' clinical development program and its regulatory engagement with FDA regarding the resubmission of midomafetamine. Dr. Hough previously spent 17 years with Johnson & Johnson, where he oversaw the Spravato® (esketamine) Phase 3 development and approval in two indications across multiple markets. "Charting a path toward FDA approval will require seasoned leadership and expertise," said Suprotik (Protik) Basu, Lykos board director and managing partner at Helena, Lykos's lead investor. "I've gotten to know both Mike and Dave over the past year, and I have deep conviction in their ability and commitment to bringing this treatment, if approved, to the millions who are waiting with great hope." Michael Mullette is an experienced pharmaceutical industry leader who joined Lykos as Chief Operating Officer in March 2022 following over two decades with Sanofi and Moderna. He most recently served as Vice President of North America commercial operations for Moderna, where he oversaw commercialization of the company's COVID-19 vaccine during the pandemic. Before joining Moderna, he spent nearly 20 years with Sanofi working in commercial, business development, operations, strategy, planning, marketing, and sales roles of increasing responsibility including leadership roles across the U.S., France, Japan, Australia, and Canada. Mike earned his Bachelor of Business Administration from Villanova University and M.B.A. from Lehigh University. David Hough, M.D., is a board-certified psychiatrist and pharmaceutical executive with deep expertise in central nervous system (CNS) drug development. He previously served as Vice President of Research and Development at J&J Innovative Medicine (a Johnson & Johnson company) and other leadership roles over the course of 17 years. He was the compound development team leader for INVEGA (paliperidone), INVEGA SUSTENNA, and INVEGA TRINZA as well as for SPRAVATO® (esketamine nasal spray), where he was responsible for all medical, scientific, manufacturing, quality, preclinical, and commercial aspects of the program. Prior to his work at J&J, Dr. Hough graduated from West Point and served as an Army officer before attending medical school at the Uniformed Services University of the Health Sciences (USUHS). He completed his residency training in Psychiatry at Walter Reed Medical Center and subsequently served for 10 years as an Army psychiatrist, where he treated soldiers, retirees, and family members with a variety of behavioral health issues, including many with trauma and PTSD. He is board certified in both Adult and Geriatric Psychiatry, and he previously held an Adjunct Assistant Professor of Psychiatry position at USUHS. 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. 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 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.1 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.2,3 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.4 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.5 Lykos 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 and on LinkedIn, X, Instagram and Facebook. 1 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 2 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 3 Vollenweider, Franz X.,Dialogues Clin Neurosci. 2001 Dec; 3(4): 265–279.doi: 10.31887/DCNS.2001.3.4/fxvollenweider 4 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) 5 Yazar-Klosinski B, Mithoefer MC. Potential psychiatric uses for MDMA. Clinical Pharmacology & Therapeutics. 2017 Feb;101(2):194-196. doi: 10.1002/cpt.565 SOURCE Lykos Therapeutics