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MIAMI, Nov. 27, 2023 (GLOBE NEWSWIRE) -- ADvantage Therapeutics, Inc. (œADvantage or œthe Company), a pioneer in developing therapies for neurodegenerative conditions by addressing the biology of...
ADvantage Therapeutics appoints Dr. Carmela Abraham as Chief Science Officer
BOSTON, Oct. 02, 2023 (GLOBE NEWSWIRE) -- Klogenix LLC (œKlogenix or œthe Company) is pleased to announce that its intellectual property portfolio has been acquired by ADvantage Therapeutics, Inc....
MIAMI, June 20, 2023 (GLOBE NEWSWIRE) -- ADvantage Therapeutics, Inc. (œADvantage or œthe Company), a pioneer in developing therapies for neurodegenerative conditions with a focus on Alzheimer™s...
MIAMI, April 05, 2023 (GLOBE NEWSWIRE) -- ADvantage Therapeutics, Inc. (“ADvantage” or “the Company”), which is developing therapies to treat neurodegenerative conditions with a central focus on Alzheimer’s Disease (AD), today announced that the Medicines and Healthcare products Regulatory Agency (MHRA), the United Kingdom National Competent Authority, has granted the Company’s lead compound AD04™ an Innovation Passport for the treatment of AD under the Innovative Licensing and Access Pathway (ILAP). nnILAP was established in 2021 to reduce the time to market for innovative medicines in the United Kingdom. According to the Agency, the ILAP combines the MHRA’s globally recognized strengths of independence and high standards of quality, safety, and efficacy, with improved efficiency and flexibility, readying the MHRA for a new era in medicines approvals in the UK. The designation allows for significant input and collaboration with the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and NHS England and NHS Improvement (NHSE&I). In addition, patients are also considered key partners and the patient voice is integrated at every development stage. The MHRA indicates that ILAP incorporates broad and inclusive concepts of innovation and patient need. nn“We are delighted that MHRA has recognized the potential of AD04™ at same time we are launching our confirmatory trial,” said Jeffrey Madden, chief executive officer of ADvantage. “AD04™ may completely change the approach to the treatment of Alzheimer’s Disease. The ILAP designation creates an accelerated pathway to approval, commercialization, and patient access, by providing a more open dialogue with all the U.K. agencies, including NICE, which oversees access and integration of novel therapies into the National Health Service (NHS) and NHS Wales. We believe our novel immunotherapy for Alzheimer’s has a low manufacturing cost, simple storage, subcutaneous administration, and believe that forthcoming clinical studies will confirm safety, efficacy and tolerability. If proven and approved, the rapid introduction of AD04™ into the U.K. health system may support accelerated clinical adoption in other worldwide healthcare systems.” nnThe Phase 2b trial for AD04™ in the ILAP application will be a randomized, placebo-controlled, double-blind study to confirm proof of concept and establish the safety and efficacy of AD04™ in mild AD patients. The 12-month study will measure hippocampal volume as an objective/biomarker endpoint. Other measured outcomes include the Alzheimer’s Disease Assessment scale – cognition 13-item scale (ADAScog13), the Alzheimer’s Disease Cooperative Study – Activities of Daily Living Standards (ADCS-ADL), the Clinical Dementia Rating – sum of boxes (CDR-sb), the patient Quality of Life-Alzheimer’s Disease and the Neuropsychiatric Inventory (NPI). nnA 2mg dose of AD04™ served as a control in a prior study of another compound, where it demonstrated a statistically significantly slower decline in outcomes (cognition, function and quality of life) than other arms of that trial. In addition, the AD04™ control group showed slower decline in MRI-measured hippocampal volume as a biomarker of AD progression. To date, preclinical studies have shown that AD04™ decreased the number of inflammatory microglial cells in the hippocampus of mouse models. Inflammation and hyperproliferation of microglial cells are pathological immunological events in the brain of Alzheimer’s patients. nnDr. Rudolph Tanzi, who serves as Chair of the Scientific Advisory Board at ADvantage Therapeutics, Inc. stated, “The democratization of Alzheimer’s disease treatments that are safe, effective, and affordable for all are of utmost importance. We hope this AD04 trial with ILAP designation will bring us one step closer,” he concluded.
Renowned Public Health Advisor Jim O’Neill Joins Board of Directors of ADvantage Therapeutics