PaxMedica (NASDAQ: PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, has completed the execution of three pivotal registration/validation batches of PAX-101, which is an IV formulation of suramin. According to the announcement, this is an important milestone achievement as the company works toward enabling a New Drug Application (“NDA”) submission to the U.S. Food and Drug Administration (“FDA”). Currently, the company anticipates submitting the NDA in Q4 2024; this will mark another key milestone as the company works toward the potential commercial availability in the United States of the first and only form of suramin for the treatment of Stage 1 Human African Trypanosomiasis (“HAT”). “This is a very significant milestone for PaxMedica as it endeavors to move PAX-101 towards an NDA submission,” said PaxMedica chair and CEO Howard Weisman in the press release. “The long-term vision for PaxMedica is to further clinical investigation of PAX-101 as a treatment for individuals who struggle with autism spectrum disorder. With this important manufacturing milestone completed, we have removed a major impediment to testing PAX-101 as a treatment for the core symptoms of autism spectrum disorder. This also progresses us towards our goal of being able to be a consistent and reliable global source of this lifesaving drug for the treatment of HAT currently listed as one of the World’s Essential Medicines. It is our goal to ultimately conduct clinical trials for the use of PAX-101 in the treatment of the core symptoms of Autism Spectrum Disorder. There are currently no approved medications for the core symptoms Autism Spectrum Disorder.”
To view the full press release, visit https://ibn.fm/IgGLA
About PaxMedica Inc.
PaxMedica is a forward-looking, clinical-stage biopharmaceutical firm specializing in cutting-edge, anti-purinergic drug therapies (“APT”) aimed at addressing a range of challenging neurologic disorders. The company’s comprehensive portfolio encompasses a spectrum of conditions, including neurodevelopmental disorders such as autism spectrum disorder (“ASD”) as well as other critical areas within the neurology field. Additionally, the company intends to provide the rest of the world with an additional, reliable source of suramin, the accepted standard of care for Stage 1, Trypanosoma Brucei Rhodesiense. PaxMedica is dedicated to the continuous development and evaluation of its pioneering program, PAX-101, an intravenous suramin formulation that lies at the heart of the company’s efforts, particularly focused on innovative ASD treatment solutions. The company’s ongoing research initiatives not only prioritize the needs of ASD patients but also extend to exploring potential therapeutic applications for related conditions. For more information about the company, visit www.PaxMedica.com.
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