PaxMedica Submits Clinical Trial Request in Autism Spectrum Disorder

• ASD-101 protocol submitted to SAHPRA, South Africa’s regulatory agency
• PAX-101 internally developed supply chain entering final stages

TARRYTOWN, NY, June 14, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (APT) for the treatment of Autism Spectrum Disorder (ASD) and other serious conditions with intractable neurologic symptoms, today announced that it has submitted a request to the South African Health Products Regulatory Authority (SAHPRA), seeking approval to conduct a double-blind, placebo-controlled study, PAX-ASD-101.  This trial will seek to enroll a total of 30 subjects with confirmed ASD, ages 4 to 18, at multiple sites in South Africa.  This is the first new clinical trial on the safety, tolerability, and efficacy of suramin since the Company announced the results of its prior Phase II trial in 2021. Enrollment is expected to begin in Q4 2023, following SAHPRA’s potential approval later this summer.

PaxMedica is also preparing additional submissions for planned PAX-101 trials with other regulatory authorities outside of South Africa in 2023.

“In 2021, PaxMedica reported that it had completed a Phase II clinical trial on the use of suramin in boys with ASD.  That trial achieved marked and sustained improvement in several efficacy assessment measures and demonstrated tolerability and safety across two different doses of PAX-101,” said Howard Weisman, CEO of PaxMedica. “The results of this new proposed trial will inform the submission of an IND for multicenter trials in the US with PAX-101.”

PaxMedica is in the final stages of scaled manufacturing of the PAX-101 API and drug product to ensure the availability of the drug for clinical trials, registration and validation for both HAT and ASD programs.

About PaxMedica

PaxMedica is a clinical stage biopharmaceutical company focusing on the development of anti-purinergic drug therapies (“APT”) for the treatment of disorders with intractable neurologic symptoms, ranging from neurodevelopmental disorders, including Autism Spectrum Disorder (“ASD”), to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”), a debilitating physical and cognitive disorder believed to be viral in origin and now with rising incidence globally due to the long term effects of SARS-CoV-2 (“COVID-19”). One of PaxMedica’s primary points of focus is the development and testing of its lead program, PAX-101, an intravenous formulation of suramin, in the treatment of ASD and the advancement of the clinical understanding of using that agent against other disorders such as ME/CFS and Long COVID-19 Syndrome, a clinical diagnosis in individuals who have been previously infected with COVID-19.

For more information, visit www.paxmedica.com.

Forward-Looking Statements

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 Annual Report on Form 10-K, most recent quarterly filings and other filings with the U.S. Securities and Exchange Commission.

Contacts:

Stephanie Prince
PCG Advisory
sprince@pcgadvisory.com
(646) 863-6341