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Veralox Therapeutics Announces FDA Orphan Drug Designation for VLX-1005
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.
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.
Jeffrey Strovel, CEO