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January 26, 2021
Veralox Therapeutics Announces FDA Orphan Drug Designation for VLX-1005
FREDERICK, Md – January
26, 2021 – Veralox Therapeutics, a biotechnology company developing
first-in-class small molecule therapeutics that treat the underlying pathologies
of diseases with significant unmet medical needs, today announced that the U.S.
Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for
VLX-1005 for the treatment of heparin induced thrombocytopenia (HIT).
“We are pleased the FDA has granted Orphan Drug Designation
for VLX-1005 for prophylaxis of thrombosis in patients with heparin-induced
thrombocytopenia,” said Jeffrey W. Strovel, PhD., Chief Executive Officer of Veralox
Therapeutics. “This is a significant regulatory
milestone for our company, and in the development of this investigational new
drug product and recognition of the clear unmet medical need for patients who
suffer from this devastating disease.”
“We believe VLX-1005, with its
novel mechanism of action, has great potential to be the first disease
modifying therapy for HIT in over 20 years,” said Matthew B. Boxer, PhD., Chief
Operating Officer of Veralox Therapeutics.
The FDA, through
its Office of Orphan Products Development (OOPD), grants orphan
status to drugs and biologic products that are intended for the safe and
effective treatment, diagnosis, or prevention of rare diseases or conditions
that affect fewer than 200,000 people in the United States, or that affect
more than 200,000 people but are not expected to recover the costs of drug
development and marketing. Orphan drug designation provides eligibility for
certain development incentives, including tax credits for qualified clinical
testing, prescription drug user fee exemptions and seven-year marketing
exclusivity upon FDA approval.
About VLX-1005
VLX-1005 is a first-in-class and
selective small molecule inhibitor 12-Lipoxygenase, a key target within the
arachidonic acid pathway. Preclinical data has demonstrated that VLX-1005 halts
immune driven platelet activation and thrombosis thus offering the potential of
a lifesaving treatment for patients with HIT.
About Veralox Therapeutics
VERALOX Therapeutics Inc.
(https://veralox.com/)
is developing first-in-class therapeutics that target the underlying
pathologies of diseases with unmet medical needs. The company’s lead candidate,
VLX-1005, will be developed initially to treat patients with heparin-induced
thrombocytopenia (HIT). Second generation therapeutic products are under
development for T1D and other immune-mediated and inflammatory diseases.
