Company provides update on regulatory progress towards US NDA submission

TARRYTOWN, NY / ACCESSWIRE / August 27, 2024 / PaxMedica, Inc. (OTC PINK:PXMD), a clinical-stage biopharmaceutical company dedicated to advancing treatments for neurological disorders, is pleased to announce a significant milestone in its global health efforts. The Malawi Ministry of Health has informed the company that a patient suffering from the potentially fatal parasitic infection known as Human Africa Trypanosomiasis Brucei Rhodesiense, (HAT), commonly referred to as African Sleeping Sickness, has recently received treatment with PAX-101, an intravenous form of Suramin, and is recovering at home. The Rhodesiense strain of Human African Trypanosomiasis is nearly 100% fatal if not treated promptly, and Suramin is considered the standard of care in Malawi, and many East African countries, in preventing death due to this parasite, when used in the early or first stage of the infection.

In April, the company announced that the Ministry of Health of Malawi made an emergency request for PaxMedica to provide immediate access to the recently completed validation and registration batches of PAX-101 (IV Suramin). This urgent request set in motion several important steps to rapidly respond to a critical global shortage of Suramin which is used routinely to combat HAT in Malawi. PaxMedica informed the U.S. FDA Office of Global Policy and Strategy that the company had provided a limited quantity of its formulation of IV Suramin, PAX-101, to Malawi's Ministry of Health, for immediate use.

Howard Weisman, CEO of PaxMedica, commented, "This first use of PAX-101 to treat a critically ill patient with Stage 1 HAT infection is an important milestone for the company following years of investment in the formulation and commercial scale-up of Suramin, the active pharmaceutical ingredient of PAX-101, with the company's supply chain partners. We were contacted by the government of Malawi after sustained shortages of IV Suramin in the region in the past year, and we could not ignore their pleas for help. Responding to this extraordinary request demonstrates our commitment to provide this essential medicine to some of the world's most vulnerable people."

Marshal Lemerani, Director of Neglected Tropical Diseases at the Ministry of Health in Malawi, expressed the nation's gratitude, stating, "We know that access to IV Suramin is necessary for us to save lives in our fight against HAT and, through the generosity of PaxMedica, we are now able to respond to the desperate need for this treatment. The results we've seen so far are very promising, and having a company committed to produce this vital drug offers renewed hope for our patients, and strengthens our ability to combat this devastating disease."

PaxMedica has also received feedback from U.S. Food and Drug Administration (FDA) on proposed plans to work with the Malawi Neglected Tropical Disease Program to establish a patient registry in Malawi for documenting treatment outcomes with PAX-101. This registry will be used to support the upcoming New Drug Application (NDA) for the use of PAX-101 in the treatment of Stage 1 HAT with data from the landmark PAX-HAT-301 Real World Evidence Phase 3 African Sleeping Sickness Study as previously reported by the company as a historical control. The company expects to submit an NDA for PAX-101 as a treatment for HAT in the near future.

About PaxMedica

PaxMedica, Inc. 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. Our 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, we intend 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.

We are dedicated to the continuous development and evaluation of our pioneering program, PAX-101, an intravenous suramin formulation that lies at the heart of our efforts, particularly focused on innovative ASD treatment solutions. Our ongoing research initiatives not only prioritize the needs of ASD patients, but also extend to exploring potential therapeutic applications for related conditions. To learn more about our transformative work, please visit www.paxmedica.com.

Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for Email Alerts at https://www.paxmedica.com/email-alerts and by following PaxMedica on Twitter and LinkedIn.

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, and distribution and demand for our product candidates. 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, regulatory approvals 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.

Contacts

PaxMedica, Inc.
303 S Broadway,
Suite 125.
Tarrytown, NY 10591
www.paxmedica.com

Media Contact
media@paxmedica.com

Investor Contact
Scott McGowan
InvestorBrandNetwork (IBN)
Phone: 310.299.1717
ir@paxmedica.com
www.paxmedica.com/investors

SOURCE: PaxMedica, Inc.