PaxMedica Inc. (NASDAQ: PXMD) Announces PAX-101 Batch Completion for NDA Application to FDA

  • PaxMedica has completed its three registration/validation batches of PAX-101, an IV formulation of suramin
  • The completed batches are a significant step toward submitting a New Drug Application to the U.S. Food and Drug Administration in the fourth quarter of 2024
  • PaxMedica aims to establish a sustainable global supply chain for PAX-101 and to advance research and clinical trials targeting Autism Spectrum Disorder (“ASD”), demonstrating a steadfast commitment to addressing complex neurological conditions
  • The ASD treatment market size was valued at $6.94 billion in 2022 and is projected to grow to $13.14 billion by 2030

PaxMedica (NASDAQ: PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, recently announced that it has completed its three registration/validation batches of PAX-101, an IV formulation of suramin. This accomplishment marks a significant step toward submitting a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in the fourth quarter of 2024 (https://ibn.fm/52o4M).

This step paves the way for potential commercial availability in the U.S. of Suramin, the sole form for treating Stage 1 Human African Trypanosomiasis (“HAT”) caused by Trypanosoma brucei rhodesiense. This disease, fatal and neglected, represents a critical healthcare challenge. Pending FDA approval, this milestone is crucial for PaxMedica as it seeks FDA approval for PAX-101, pending a thorough review process., which is recognized as the standard treatment for HAT outside the United States, according to the CDC.

A favorable review and NDA approval may also position the company to receive a Tropical Disease Priority Review Voucher (“PRV”). PaxMedica aims to establish a sustainable global supply chain for PAX-101, primarily as a step financially enabling the company to advance research and clinical trials targeting Autism Spectrum Disorder (“ASD”).

ASD comes with different challenges, and PaxMedica’s robust pipeline of products may help reduce, or modulate some of the more troublesome aspects of ASD. This advancement would allow people with autism to integrate their behavior with others more successfully and improve their lives.

According to Fortune Business Insights, the ASD treatment market size was valued at $6.94 billion in 2022 and is projected to grow to $13.14 billion by 2030, expanding at a CAGR of 8.5% during the forecast period. The growing prevalence of ASD and increasing access to treatment options are encouraging more ASD patients and their families to seek treatment regimens (https://ibn.fm/aavzi).

Howard Weisman, chairperson and CEO of PaxMedica, commented on the recent developments, stating, “This completion of our registration/validation batches is a crucial step as we prepare for an NDA submission for PAX-101. It marks a significant milestone in our ongoing efforts.” He further elaborated, “Our long-term vision includes extending our clinical investigations of PAX-101 as a potential treatment for individuals with Autism Spectrum Disorder. This manufacturing achievement has significantly aided in overcoming one of the major barriers to initiating further tests on PAX-101 for addressing the core symptoms of ASD, which remain under investigation.”

“The progress we’ve made brings us closer to our objective of becoming a reliable global supplier of suramin, particularly for treating Stage 1 Human African Trypanosomiasis (‘HAT’), a condition for which suramin is recognized as one of the World’s Essential Medicines,” Weisman added. “It is our aim to eventually undertake clinical trials to explore the use of PAX-101 for the core symptoms of ASD. It is important to note that there are currently no approved medications that address these symptoms directly, making our research both challenging and essential.”

PaxMedica is on a promising path to change the future of ASD, bringing hope to millions. The company hopes to add this important new treatment option to improve the prospect of independence. It has the potential to help adolescents and young adults lead brighter, more independent lives.

For more information, visit the company’s website at www.PaxMedica.com.

NOTE TO INVESTORS: The latest news and updates relating to PXMD are available in the company’s newsroom at https://ibn.fm/PXMD

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