via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage
biopharmaceutical company focusing on the development of novel
anti-purinergic drug therapies (“APT”) for the treatment of
disorders with intractable neurologic symptoms, today provided a
business update and reported financial results for the second
quarter 2023, ended June 30, 2023.
Recent Highlights
- Announced positive
top line results from the PAX-101 (intravenous suramin) Phase 3
African Sleeping Sickness Study, PAX-HAT-301, paving the way for an
expected NDA filing in 2024
- Granted Exclusive
Pharmacy Distribution Rights for PAX-101 to Vox Nova, LLC, the
first purpose-built limited distribution specialty pharmacy benefit
manager for people with autism spectrum disorder (“ASD”) and their
families
- Submitted PAX-101
Clinical Trial Request to the South African Health Products
Regulatory Authority (SAHPRA), requesting approval to conduct a
double-blind, placebo-controlled study in ASD
- Entered into
Research Collaboration Agreement with PoloMar Health and The BRAIN
Foundation for Phase II Study in ASD
- Phase II
proof-of-concept trial using a proprietary, highly bioavailable
form of emodin in patients with ASD is expected to begin in 2H
2023
Howard Weisman, Chief Executive Officer of PaxMedica, commented,
“During the second quarter of 2023 we achieved several important
milestones on our path for a 2024 US FDA filing of an NDA for the
treatment of Stage 1 TBR HAT with PAX-101 (IV suramin).
Importantly, this positive topline data from our retrospective
HAT-301 study, demonstrated both statistically significant and
clinically meaningful results. This important, real-world evidence
study, from over 100 years of clinical experience ranging from
before the availability of suramin to the present day, demonstrated
the benefits of suramin in treating this potentially fatal
infection. With the final study results in hand, PaxMedica is now
firmly on the path towards initiating future studies of PAX-101 in
treating other conditions, including the core symptoms of ASD.”
As of June 30, 2023, PaxMedica had $3.1 million in cash and
remaining access to $15.2 million from the Company’s committed
equity investment agreement for up to $20 million with Lincoln Park
Capital. Common shares issued and outstanding at June 30, 2023
totaled 15,369,477. Subsequent to quarter end, the Company received
proceeds of approximately $0.8 million from the issuance of
approximately 1.0 million shares of the Company’s common stock.
For PaxMedica’s complete financial results for the three-month
period ended June 30, 2023, see the Company’s Quarterly Form 10-Q
that will be filed with the Securities and Exchange Commission on
August 9, 2023.
About the Phase 3 HAT-301 Trial and Results
Launched in November 2022, the Phase 3 HAT-301 trial is a
pivotal, retrospective, non-randomized, externally controlled,
interventional efficacy and safety 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 has been underway at multiple primary HAT
treatment sites in Uganda and Malawi using exclusively licensed,
retrospective clinical data that is being reviewed and compared
with a natural history controlled dataset comprised of exclusively
licensed source data. The study, if successful, is expected to lead
to the submission of a New Drug Application (NDA) for PAX-101 to
treat the rare tropical disease, Stage 1 TBR HAT, an important
milestone that we expect to trigger a Priority Review Voucher (PRV)
application, which, if granted, we expect to monetize to advance
our work.
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 TBR HAT since at
least 1920, as a standard of care for Trypanosoma b.
Rhodesiense.
In July 2023, PaxMedica announced positive top line data for
both efficacy and safety from the study. In the suramin-treated
cohort of 121 individuals, 114 (94%) survived and completed the
treatment regimen. Within the natural history cohort of 42
individuals, 6 (14%) recorded as cured, improved, or discharged, 3
(7%) died, 10 (24%) experienced clinical worsening, and 17 (40%)
achieved moribund status (near death or in terminal decline).
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 program, 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, visit www.paxmedica.com .
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, statements about the strength of our
balance sheet. 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 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 Annual Report on Form 10-K, most recent
quarterly filings and other filings with the U.S. Securities and
Exchange Commission.
Contactsir@paxmedica.comStephanie PrincePCG
Advisorysprince@pcgadvisory.com(646) 863-6341
PaxMedica (NASDAQ:PXMD)
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