AC-101

SUZHOU, China, May 24, 2023 /PRNewswire/ -- Accropeutics Bioscience announced that its oral small molecule TYK2/JAK1 inhibitor AC-201 has been approved by the Australian Human Research Ethics Committee (HREC) to launch a clinical phase I trial in Australia. The trial will be a randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and food effects of AC-201 in healthy adults. AC-201 is a novel small molecule inhibitor of TYK2/JAK1 with high activity, selectivity, and safety window. The preclinical studies have shown that AC-201 effectively binds to the pseudo kinase domain (JH2) of TYK2/JAK1, stabilizing the self-inhibitory conformation of the pseudo kinase domain on the kinase domain, thereby inhibiting the function of TYK2/JAK1 kinase. It demonstrated significant efficacy in multiple animal models of diseases, including psoriasis, and is intended for the treatment of psoriasis and other inflammatory and autoimmune diseases. As an oral drug candidate, AC-201 may provide convenience and efficacy with good safety for psoriasis patients. Dr. Xiaohu Zhang, Co-founder and CEO of Accropeutics Bioscience, said: "AC-201 is the third oral small molecule drug candidate developed by Accropeutics Bioscience to enter the clinical stage. Our company has obtained three clinical approvals this year and five since December 2021. We are committed to advancing these programs and aspire to bring relief to patients globally through these drug candidates ." About Accropeutics Bioscience Accropeutics Bioscience is a clinical-stage biotech company with a core focus on molecular mechanisms of regulated cell death and related pathogenesis in human diseases. The company has developed a robust portfolio of innovative compounds in various stages of development, spanning from lead optimization to clinical trials. RIPK1 inhibitor AC-003 was approved for clinical testing by FDA and NMPA in December 2021 and August 2022, respectively. The phase I trial of AC-003 is wrapping up and a phase Ib-II trial is planned for aGVHD. In the Phase I study, AC-003 was rapidly absorbed in the gastrointestinal tract after oral administration, with a peak time of 1-2 hours. The peak concentration and exposure increased linearly for the 10-480 mg dose groups, and there was no drug accumulation after multiple dose administration. Pharmacokinetic parameters supported a once-daily dosing regimen. AC-003 was well tolerated with only grade 1 adverse events reported in the Chinese (Chinese, ethnic) and US (Caucasian, African-American, Asian) participants. RIPK2 inhibitor AC-101 was approved by HREC in March 2023 and is currently in Phase I in Australia. AC-201, a selective TYK2/JAK1 inhibitor with huge potential for treating inflammatory and autoimmune diseases, was approved by HREC in May 2023 and is scheduled to launch clinical trial in Australia in the near future. The company has multiple compounds in PCC and preclinical stages. Accropeutics Bioscience owns global rights of all its assets with more than 10 patents issued in China, Japan, Korea, US and EU. Media Contact: Jie Xu, [email protected] SOURCE Accro Bioscience (Suzhou) Limited

TORONTO, ON / ACCESSWIRE / September 26, 2022 / DAMONA Pharmaceuticals today announced the closing of a seed stage financing round to support the development of its lead therapeutic for the treatment of cognitive symptoms associated with depression and diseases of aging. The syndicated investment was co-led by the Angelini Lumira Biosciences Fund and Noetic Fund and included participation from Toronto Innovation Acceleration Partners (TIAP), and several family offices. In addition to the equity financing, the company has received significant financial support from the Centre for Addiction and Mental Health (CAMH), the Ontario Brain Institute and additional early stage development programs. Proceeds from these financings will support the development of the company, its lead AC-101 which was licensed from CAMH, UWM Research Foundation Inc., University of Tours and University of Belgrade-Faculty of Pharmacy, and additional early stage development programs. DAMONA's mission is the discovery and development of first-in-class modulators of GABA neurotransmitters that target and restore impaired brain functions in patients suffering from cognitive symptoms. Promising data generated from testing in preclinical models has demonstrated the ability of AC-101 to specifically target and activate impaired brain receptors and to rapidly improve cognitive symptoms while renewing and repairing underlying brain dysfunctions, thereby offering the potential of reversing the impairment and in doing so resolve previously unresolvable symptoms. "The Lumira team was first drawn to the DAMONA opportunity by the quality and depth of the science being generated by company founder Dr. Etienne Sibille, a world-leading scientist in the areas of neuroscience and neuropharmacology. Over the past several years, we built a strong working relationship with Dr. Sibille which enabled us to see the terrific progress culminating in the selection of its lead, AC-101, which the company now plans to take into IND enabling studies." said Jacki Jenuth, Partner and COO of Lumira Ventures. "Currently, there are no medications available to treat cognitive symptoms such as memory loss and inability to focus that occur in association with depression, aging, and other mental illnesses. DAMONA's lead program and pre-clinical pipeline offer real hope for patients suffering from these devastating disorders," said Sri Teja Mullapudi, Principal of Noetic Funds. "We are grateful for the support from all of our investors and supporters who have brought us to where we are today," said Dr. Etienne Sibille, Interim CEO and Chief Scientific Officer of DAMONA Pharmaceuticals. "We look forward to working with our new partners and utilizing the capital from this financing to complete our pre-clinical studies and take our program to the clinic." "As a world leader in mental health and brain sciences research, we are proud to work with Angelini, Lumira, Noetic, TIAP, OBI and others to move this critical work to its next stage," added Dr. Aristotle Voineskos, Vice President of Research and Director of the Campbell Family Mental Health Research Institute at CAMH. "This investment brings us one step closer to helping the millions of people affected by cognitive symptoms associated with depression and diseases of aging." About DAMONA Pharmaceuticals DAMONA is a privately held pre-clinical pharmaceutical company founded by Dr. Etienne Sibille and the Centre for Addiction and Mental Health (CAMH) on a mission to develop small molecule therapeutics that transform the treatment of cognitive symptoms and restore normal life functions for underserved and understudied mental health and aging populations. About Angelini Lumira Biosciences Fund Angelini Lumira Biosciences Fund is a venture capital fund established by Angelini Pharma in partnership with Lumira Ventures. The Fund focuses on early stage investments in North American based companies developing products targeted at rare and central nervous system diseases. Angelini is an international pharmaceutical company, part of the Italian privately-owned Angelini Group. Angelini Pharma is committed to helping patients in the therapeutics areas of central nervous system and mental health, rare diseases, and consumer healthcare. Angelini Pharma operates directly in 25 countries employing almost 3,000 people and commercializes its products in more than 70 countries through strategic alliances with leading international pharmaceutical groups. Lumira Ventures is a North American healthcare venture capital firm with two-decades of experience of investing in and helping to build transformative life science based companies. Lumira Ventures manages its activities from offices in Toronto, Montréal, Vancouver and Boston. For more information, please visit About Noetic Noetic was founded in early 2020 with a vision to disrupt how mental health indications are treated and managed. Through its venture capital funds, Noetic invests globally to build emerging technologies in molecular therapeutics/biotech, digital health, medical devices, and wellness with a focus on mental health, pain, and other complications resulting from the central nervous system. About CAMH The Centre for Addiction and Mental Health (CAMH) is Canada's largest mental health and addiction teaching hospital and a world leading research centre in this field. CAMH combines clinical care, research, education, policy development and health promotion to help transform the lives of people affected by mental illness and addiction. CAMH is fully affiliated with the University of Toronto, and is a Pan American Health Organization/World Health Organization Collaborating Centre. For more information, please visit camh.ca or follow @CAMHnews on Twitter. For more information DAMONA pharmaceuticals Etienne Sibille Etienne.sibille@damonapharma.com SOURCE: DAMONA Pharmaceuticals View source version on accesswire.com: