PaxMedica Initiates Clinical Program to Advance PAX-101 Towards FDA Submission
November 08 2022 - 8:00AM
via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage
biopharmaceutical company focusing on the development of
anti-purinergic drug therapies for the treatment of disorders with
intractable neurologic symptoms, today announced that it has
initiated a Phase 3 trial, HAT-301, as part of its strategic plan
to obtain US market approval of PAX-101 (intravenous
suramin).
The Phase 3 HAT-301 trial is a pivotal, retrospective,
controlled analysis of suramin for the treatment of the rare and
fatal tropical disease, Stage 1 Trypanosoma Brucei Rhodesiense
Human African Trypanosomiasis (Stage 1 TBR HAT). The study is
underway at multiple primary HAT treatment sites in Uganda and
Malawi. The Phase 3 trial is using exclusively licensed,
retrospective clinical data that will be reviewed and compared with
a natural history controlled dataset comprised of exclusively
licensed source data.
The primary objective of the study is to demonstrate that the
standard of care treatment using suramin, as currently practiced in
Uganda and Malawi, leads to better clinical outcomes in patients
with Stage 1 TBR HAT than observed in an untreated natural history
cohort, that had documented illness prior to availability of
suramin. The World Health Organization lists suramin, discovered in
1916, and found to be effective against Stage 1 HAT since at least
1920, as a standard of care for Trypanosoma b. Rhodesiense.
Howard Weisman, Chief Executive Officer of PaxMedica, commented,
“We’re excited to have launched this critical study that, if
successful, is an important milestone for the submission of a New
Drug Application (NDA) for PAX-101 to treat the rare tropical
disease, HAT. This is an important part of PaxMedica’s strategy
that we believe is the fastest route to funding widespread clinical
testing of suramin in autism spectrum disorder and other
neurological conditions that lack effective treatments. We look
forward to reviewing the final results of the study, which are
expected in the first half of 2023.”
PaxMedica has formally met with the FDA three times to review
the Phase 3 clinical trial plan. The study has the potential to
serve as the pivotal efficacy component of an NDA. If an NDA
for PAX-101 in HAT is approved, PaxMedica may be eligible to
receive a priority review voucher from the FDA, which can be
redeemed by the Company for priority review in a subsequent
marketing application or potentially monetized by transferring the
voucher to a third party.
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 compound, 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, please visit:
www.paxmedica.com.
Forward-Looking Statements
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Forward-looking statements reflect our current view about future
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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 in the Company's most recent quarterly report on
Form 10-Q and other filings with the SEC.
Stephanie PrincePCG Advisorysprince@pcgadvisory.com(646)
863-6341
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