FDA grants fast track designation to VLX-1005 for heparin-induced thrombocytopenia
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The FDA granted fast track designation to VLX-1005 for treatment of heparin-induced thrombocytopenia.
VLX-1005 (Veralox Therapeutics) is a novel 12-LOX inhibitor.
A phase 1A study consisted of a single ascending dose portion and a multiple ascending dose portion designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of VLX-1005.
Results showed VLX-1005 to be well-tolerated, with no reports of serious adverse events, dose-limiting toxicities or discontinuations, according to a Veralox Therapeutics-issued press release. Adverse events were mild and infrequent, according to the release.
Researchers reported dose-linear increases in key pharmacokinetic metrics, with no upper limits on tolerability to the maximum dose tested.
A phase 1B drug-drug interaction study assessed VLX-1005 in conjunction with argatroban, an anticoagulant approved in the United States for treatment of heparin-induced thrombocytopenia.
Results showed the combination appeared well-tolerated, with no serious adverse events. Once again, adverse events appeared mild and infrequent, and preliminary analysis of pharmacokinetics and pharmacodynamics showed no evidence of drug-drug interactions.
"Completion of our phase 1 study for VLX-1005 together with announcement of fast track designation for this program represent important milestones that reflect the new levels of momentum we are achieving with our clinical strategy," Michael Hanna, MD, FACC, chief medical officer at Veralox, said in the release. “We look forward to continuing our development of VLX-1005 to address the underlying pathology of [heparin-induced thrombocytopenia], a disease that has not seen innovation in available therapies in over 20 years.”
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