- PaxMedica is preparing to submit a New Drug Application to the U.S. Food and Drug Administration for suramin to treat Human African Trypanosomiasis
- On June 27th, PaxMedica will have a Type C meeting with the FDA, pivotal for the progress of PAX-101, their leading drug candidate for autism treatment, within the regulatory framework
- The outcomes of this FDA meeting are crucial, representing a key moment for PaxMedica to demonstrate the therapeutic potential and public health benefits of PAX-101
- The global ASD therapeutics market is projected to grow from $2.01 billion in 2023 to $3.42 billion by 2030, driven by increasing prevalence, rising awareness, and investment in R&D
PaxMedica (NASDAQ: PXMD), a biopharmaceutical company specializing in neurological disorder treatments, is preparing to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for suramin to treat Human African Trypanosomiasis, a century-old treatment in East Africa. In April 2024, PaxMedica underscored its commitment to global health by responding to an urgent request from Malawi for an emergency release of suramin, demonstrating its dedication to advancing healthcare solutions.
On June 27th, PaxMedica will have a crucial Type C meeting with the FDA, pivotal for the progress of PAX-101, their leading drug candidate for autism treatment, within the regulatory framework. Type C meetings with the FDA address specific drug development issues like clinical trial design and data requirements, not covered by Type A or Type B meetings. This meeting will be a strategic opportunity for PaxMedica to discuss PAX-101’s development steps and ensure compliance with regulatory standards.
This upcoming meeting is a significant event for PaxMedica, as it aims to align with the FDA on PAX-101, an intravenous formulation of suramin that could potentially treat conditions like Human African Trypanosomiasis and Autism Spectrum Disorder (“ASD”). By engaging with the FDA, PaxMedica seeks to clarify regulatory pathways and address potential clinical trial hurdles, moving PAX-101 closer to market approval.
The outcomes of this FDA meeting are crucial, representing a key moment for PaxMedica to demonstrate the therapeutic potential and public health benefits of PAX-101. Successfully navigating this meeting could advance clinical trials and the approval process, crucial for addressing HAT, a neglected tropical disease, and ASD, affecting millions worldwide. PaxMedica’s recent efforts, like providing suramin for HAT treatment in Malawi, highlight the company’s commitment to global health and the potential positive impact of PAX-101 on healthcare.
PaxMedica’s primary mission is to address the unmet medical needs in ASD. The company is developing PAX-101 for ASD, with a completed Phase 2B study showing promising results. Additionally, PAX-102, an intranasal formulation of suramin, is under evaluation for ASD and other neurodevelopmental conditions. The company’s commitment extends to exploring selective APTs that target specific purinergic receptors, potentially offering enhanced therapeutic benefits.
The global ASD therapeutics market is projected to grow from $2.01 billion in 2023 to $3.42 billion by 2030, driven by increasing prevalence, rising awareness, and investment in R&D. PaxMedica believes that the addressable market for PAX-101, if approved, could significantly exceed these forecasts, given the current lack of treatments targeting the core symptoms of autism (https://nnw.fm/OnrET).
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://nnw.fm/PXMD
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