PaxMedica Holds Important FDA Type-B Meeting to Review PAX-101 Pivotal Trial Data
• Key Guidance Regarding NDA Filing Obtained
TARRYTOWN, NY, Oct 26, 2023 (GLOBE NEWSWIRE) -- PaxMedica, Inc. (Nasdaq: PXMD), a clinical-stage biopharmaceutical company, announced the completion of a type-B meeting with the FDA. During the live meeting, the company discussed the positive results of the recent data from its PAX-HAT-301 study of suramin in Stage One Human African Sleeping Sickness caused by Trypanosoma brucei rhodesiense, a rare and fatal parasitic disease if left untreated.
PaxMedica has received constructive feedback which will aid in the completion of the remaining work necessary to file a New Drug Application (NDA) expected in the second half of 2024. Most of the work to achieve this important milestone will focus on completing the production of commercial lots of PAX-101 under CMC regulatory guidelines, underway now and scheduled to conclude in the first half of 2024.
"This is an important turning point for our young company, and we are very pleased with the guidance that the FDA has provided us in this meeting. We look forward to urgently completing the necessary steps in the coming months to clear the path to submit our first NDA for PAX-101," said Howard Weisman, CEO, and Chairman of PaxMedica.
For further updates and information, please visit PaxMedica's official website at www.paxmedica.com.
PaxMedica, Inc. is a forward-looking clinical-stage biopharmaceutical firm specializing in cutting-edge anti-purinergic drug therapies (APT) designed to address challenging neurologic disorders. Our scope encompasses a spectrum of conditions, from neurodevelopmental disorders, including Autism Spectrum Disorder (ASD), to the debilitating Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), marked by both physical and cognitive burdens. At PaxMedica, we prioritize the advancement and evaluation of our flagship program, PAX-101—an intravenous suramin formulation—primarily focused on ASD treatment, while also broadening our clinical insights into its potential applications for conditions such as ME/CFS. For more information, visit www.paxmedica.com.
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This press release contains “forward-looking statements.” Forward-looking statements reflect our current view about future events. Investors can identify these forward-looking statements by words or phrases such as “may,” “will,” “could,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “propose,” “potential,” “continue” or similar expressions. These forward-looking statements include our anticipated clinical program, the timing and success of our anticipated data announcements, pre-clinical and clinical trials and regulatory filings, statements about the strength of our balance sheet. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations and projections about future events that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Such risks and uncertainties include, but are not limited to, risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of the Company’s product development and clinical trials, risk of insufficient capital resources, cash funding and cash burn and risks associated with intellectual property and infringement claims. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results described in the Company’s “Risk Factors” section and other sections in its most recent Annual Report on Form 10-K, and subsequent quarterly and other filings with the U.S. Securities and Exchange Commission.