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NEW YORK--( BUSINESS WIRE )--The 34th Barometer from Sermo , an online physician and provider community and leader in healthcare insights, surveyed 430+ mental healthcare providers around the world, including psychiatrists, general practice physicians, and advanced practice providers, on their sentiments about psychedelic and dissociative drug treatments, finding that 94% would be open to integrating these treatments into their practices if legalized in their countries. Worldwide, there has been growing interest from industry, government, media, and patients in psychedelics for the treatment of mental health conditions. 89% of HCPs surveyed believe that psychedelic medicines have unique therapeutic potential compared to traditional medications in treating patients with significant mental health conditions, such as treatment-resistant depression, post-traumatic stress disorder, and anorexia nervosa. Existing Familiarity with Psychedelics: HCPs are keeping up with developing research about psychedelics for the treatment of mental health conditions. The majority of surveyed healthcare professionals (67%) were either moderately or extensively familiar with the current clinical research on psychedelic and dissociative drugs. Surveyed psychiatrists had more familiarity (71%) with clinical research than other specialties. Ketamine is the most well-known psychedelic and dissociative drug among surveyed HCPs, with 45% indicating they are extremely or very familiar with its use in treating mental health disorders. This is followed by MDMA at 29%, LSD at 26%, and psilocybin at 25%. According to one anonymous Sermo U.S. psychiatrist and survey respondent, “ Psychedelics may have potential significant benefits but they also carry significant risks. If we are to introduce them as psychiatric treatments there needs to be research on their safety and efficacy. They need to be regulated and safety measures need to be put into place. It's important that the right patients obtain benefit and that people do not abuse them. It's important that they be medically supervised to prevent just anyone from using them. Once enough research has been done, I see them integrating into psychiatric care like esketamine, with strict measures in place.” Potential Barriers & Practice Integration: If legalized, HCPs feel there are many barriers to integrating psychedelic and dissociative drug treatments into their practices. Healthcare professionals report needing clinical guidelines (80%), comprehensive training programs (78%), and guidance to legal considerations (60%). HCPs do not view psychedelic and dissociative drugs as a first-line treatment, with nearly half (45%) of surveyed HCPs citing lack of response to traditional treatments as key criteria to prescribe psychedelic and dissociative drugs to a patient. Patients are also open to the idea of psychedelic and dissociative drug treatments. 79% of those surveyed report that they noticed increasing patient interest in psychedelics as a treatment option. When asked why they felt patients are more open, the most common answer was a growing acceptance of alternative mental health treatments (64%) and increased media coverage of psychedelics (60%). Agreement with FDA Decisions Varies by Treatment: U.S. healthcare professionals aren’t always in agreement with the FDA's decisions. Despite the recent decision not to grant MDMA approval for the treatment of PTSD, 52% of HCPs believe an exception should be made for veterans, who have spent years lobbying for the drug, to receive the treatment. However, 73% agreed with the FDA’s decision to grant LSD-based medications breakthrough status for the treatment of generalized anxiety. Two U.S. states have already decriminalized psilocybin (magic mushrooms) creating easy access for residents to purchase, possess, and grow them. While many healthcare professionals are open to the future of psychedelics to treat mental health conditions, the majority (61%) do not feel patients should be able to readily access psilocybin without medical intervention for the purposes of treating depression, addiction, and PTSD. Eye on Ketamine: 52% of surveyed HCPs believe that ketamine is being prescribed “off-label” too often. Two-thirds (67%) of surveyed HCPs believe compounding pharmacies should not be allowed to distribute Ketamine. This survey was fielded August 28th- September 4th as the 34th edition of Sermo’s ongoing Barometer study. The survey included 431 psychiatrists, general practice physicians, and advanced practice providers who have treated a patient for a mental health condition in the last year from the U.S., Canada, Australia, Germany, Italy, Spain, France, and the UK. To explore more findings, visit: https://app.sermo.com/barometer About Sermo: Sermo is a fast, frictionless physician-first platform providing the healthcare industry with real-time business insights and authentic physician engagements through our global community of 1.5M healthcare professionals and state-of-the-art technology. For over 20 years, Sermo has been turning physician experience, expertise, and observations into actionable insights that benefit pharmaceutical companies, healthcare partners, and the medical community at large. To learn more, visit www.sermo.com .

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