Freedom Biosciences, Inc.

Lykos Therapeutics is not giving up the pursuit of FDA approval for its psychedelic therapy, and, as a result, has decided to lay off 75% of its workforce to focus on getting its MDMA treatment across the regulatory finish line. Lykos Therapeutics is capping off an awful week with a massive reorganization, laying off about 75% of staff in the aftermath of an FDA rejection and the retraction of three research papers on the biotech’s MDMA treatment due to protocol violations at a clinical trial site.Rick Doblin, Ph.D., the founder and president of the Multidisciplinary Association for Psychedelic Studies (MAPS), the parent company of Lykos, is also leaving 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," Doblin said in an Aug. 15 release. Lykos’ downslide started just six days ago when the FDA rejected the company’s MDMA-assisted therapy treatment for post-traumatic stress disorder. The move was not unexpected, as an advisory panel assembled by the agency had previously voted against approval. The regulator asked Lykos to run another phase 3 trial to gather more data on the treatment’s safety and efficacy.Just two days later, the journal Psychopharmacology retracted three research papers on results from Lykos’ phase 2 trials assessing MDMA. The studies included in the retracted articles were not the same studies underpinning the request for FDA approval. Authors of the studies included Lykos CEO Amy Emerson and researchers associated with MAPS. Lykos is not giving up the pursuit of FDA approval, and, as a result, has decided to lay off 75% of its workforce—about 75 people—to focus on getting MDMA across the regulatory finish line. The remaining employees will focus on ongoing clinical development, medical affairs and engagement with the FDA, according to the release.The embattled biotech is also bringing industry veteran David Hough, M.D., on board as senior medical adviser to lead the effort to resubmit Lykos’ MDMA treatment to the FDA. A psychiatrist, Hough served in various leadership roles over 17 years at J&J Innovative Medicine and was most recently the chief medical officer at Freedom Biosciences.

SAN FRANCISCO--( BUSINESS WIRE )--Biotech fund LongeVC has invested in psychedelics startup Freedom Biosciences . Founded by Yale University professor Dr. John Krystal and PsyMed Ventures co-founder Dina Burkitbayeva, Freedom Biosciences is developing next-generation therapeutics to treat mental health conditions. The company is supported by other psychedelics, biotech and longevity-focused funds and investors, including Marat Kichikov. While many psychedelics are associated with recreational use, a growing body of research supports their powerful healing effects. One of these is ketamine. Dr. Krystal discovered its anti-depressant effects, and his clinical work and research at Yale were instrumental in developing Janssen’s Spravato Esketamine spray, which received FDA approval for patients with treatment-resistant depression in 2019. “Clinical research has already shown how powerful psychedelics can be in managing difficult-to-treat mental health conditions,” Freedom Biosciences co-founder and CEO Dina Burkitbayeva said. “We are harnessing their power to offer new, more effective medicines to patients in need.” “Better mental health is essential for healthy longevity and should be treated as an integral part of the life extension agenda," LongeVC co-founder and managing partner Garri Zmudze said. “By tackling pressing psychological conditions, we strive to support lives that are mentally and physically healthier.” About LongeVC LongeVC is an international venture capital firm investing in visionary biotech companies and founders. Focusing on seed and early-stage investment, LongeVC’s mission is to bring to market breakthrough biotech that will change lives and transform the nature of our health. Its portfolio companies are deploying AI to find new treatments for chronic illnesses, developing SaaS tools to accelerate life-changing medical research and more. Learn more about LongeVC portfolio companies and join the fund as an investor at www.longevc.com About Freedom Biosciences Freedom Biosciences is a clinical-stage biotechnology platform developing next-generation viable and efficacious ketamine and psychedelic therapeutics. The company was co-founded by Dr. John Krystal, Chair of the Department of Psychiatry at Yale University, and Dina Burkitbayeva, founder of PsyMed Ventures, alongside Hunter Bouchard and Morgan Springer. Freedom Biosciences launched from stealth in 2022 and is backed by MBX Capital, Village Global and PsyMed Ventures, among others. To learn more, visit: www.freedombio.co

SAN FRANCISCO--(BUSINESS WIRE)-- Freedom Biosciences, a clinical-stage biotechnology platform developing next-generation viable and efficacious ketamine and psychedelics-based therapeutics, today announced the appointment of David Hough, MD, as Chief Medical Officer. In this role, Dr. Hough will oversee Freedom Biosciences’ clinical development programs as the company advances its pipeline of novel therapeutics for patients with mental health and addiction disorders. Dr. Hough spent nearly 17 years at Janssen Research and Development, LLC (a Johnson & Johnson company), where he held a variety of leadership positions including as the leader of the SPRAVATO® (Esketamine) compound development team. In this role, Dr. Hough oversaw the program through the development of novel indications for two severe mood disorders, and he was responsible for all the medical, scientific, manufacturing, quality, preclinical, and commercial aspects of the program. “We’re entering an important phase as we work to advance Freedom Biosciences’ current lead ketamine-based program, FREE001,” says Dina Burkitbayeva, co-founder and CEO of Freedom Biosciences. “Dr. Hough’s proven experience leading clinical development for revolutionary drugs like SPRAVATO®, INVEGA SUSTENNA® and INVEGA TRINZA® that address challenging psychiatric indications, and in successfully bringing novel therapeutics to market, will be invaluable. He is also an ideal complement to our co-founder and Chief Scientific Advisor, Dr. John Krystal, and Head of Scientific Advisory Board and Senior Medical Advisor, Dr. Robert Berman. Dr. Hough is a key addition to our world-class team.” 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 D.C., he served for 10 years as an Army psychiatrist at two separate community hospitals, and on the faculty of a psychiatry residency program in Honolulu, Hawaii. 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. “Freedom Biosciences is identifying the most efficacious combinations of chemicals and translating those discoveries into promising programs to treat a range of mental health indications,” said Dr. David Hough. “I look forward to contributing my expertise and working alongside the team.” For more information, visit: About Freedom Biosciences Freedom Biosciences is a clinical-stage biotechnology platform developing next-generation viable and efficacious ketamine and psychedelic therapeutics. The company was co-founded by Dr. John Krystal, Chair of the Department of Psychiatry at Yale University, and Dina Burkitbayeva, founder of PsyMed Ventures, alongside Hunter Bouchard and Morgan Springer. Freedom Biosciences launched from stealth in 2022 and is backed by MBX Capital, Village Global and PsyMed Ventures, among others. To learn more, visit: