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PaxMedica Inc. (NASDAQ: PXMD) Completes Key Type-B FDA Meeting, Discussing Positive Results from PAX-HAT-301 Study

  • During the live type-B meeting, PaxMedica discussed the positive results of the recent data from its PAX-HAT-301 study of suramin in Stage One HAT, also called African Sleeping Sickness
  • The FDA is allowing PaxMedica to use previous data from early tests of suramin to begin developing the drug for use in current cases of HAT
  • PaxMedica received constructive feedback, which will aid in completing the remaining work necessary to file a New Drug Application (“NDA”), expected in the second half of 2024
  • The global ASD therapeutics market was valued at $1.93 billion in 2022 and is expected to reach $3.42 billion by 2030, growing at a CAGR of 7.9%

PaxMedica (NASDAQ: PXMD), a clinical-stage biopharmaceutical company focused on the development of novel anti-purinergic therapies (“APTs”) for the treatment of Autism Spectrum Disorder (“ASD”) and other serious conditions with intractable neurologic symptoms, recently announced the completion of a type-B meeting with the Food and Drug Administration. 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 (https://ibn.fm/m7n6V).

Suramin sodium was created as a treatment for people who contracted a deadly form of Human African Trypanosomiasis (“HAT”), a form of sleeping sickness. The FDA is allowing PaxMedica to use previous data from early tests of suramin to begin developing the drug for use in current cases of HAT.

The intention for PaxMedica is to sell the drug’s approval PRV (Priority Review Voucher) for suramin for HAT to big pharma companies and raise the necessary funding needed to explore suramin for use in ASD treatments. The first step in approving suramin for HAT was the type-B meeting with the FDA. The company anticipates the next steps will drive the future of their important research and development efforts.

PaxMedica received constructive feedback, which will aid in completing 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, which are 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 the FDA provided us in this meeting,” said Howard Weisman, CEO and Chairman of PaxMedica. “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.”

According to Fortune Business Insights, the global ASD therapeutics market was valued at $1.93 billion in 2022. This market is projected to grow at a CAGR of 7.9%, resulting in a value of $3.42 billion by 2030. According to a 2020 CDC report, it is estimated that 1 out of 54 children have been diagnosed with ASD in the United States – the growing prevalence of the disease coupled awareness about the condition and available treatments are key factors expected to with the rising drive the ASD therapeutics market growth (https://ibn.fm/1Ylzn).

The company’s lead programs are focused on ASD (Autism Spectrum Disorder). Currently there is no approved pharmacologic treatment that effectively targets ASD’s cause as well as symptoms. The only treatments available on the market are designed to address symptoms of the condition rather than targeting the pathophysiology itself. PaxMedica is on a promising path to address these critical unmet medical needs and bring hope to millions.

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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