The Food and Drug Administration (FDA) has granted Fast Track designation to VLX-1005 for the treatment and prevention of heparin-induced thrombocytopenia and thrombosis.

VLX-1005 is a first-in-class, selective small molecule inhibitor of 12-lipoxygenase, a key target within the arachidonic acid pathway. In preclinical studies, VLX-1005 has been shown to halt immune driven platelet activation and thrombosis.

In a recently completed phase 1a study (ClinicalTrials.gov Identifier: NCT04783545) VLX-1005 was found to be well tolerated in healthy participants; no serious adverse events, dose-limiting toxicities, or discontinuations were reported.

Findings from a phase 1b drug-drug interaction study (ClinicalTrials.gov Identifier: NCT05325346) also showed that the concomitant use of VLX-1005 with argatroban was well tolerated with no serious adverse events or evidence of drug-drug interaction, based on a preliminary analysis of pharmacokinetics and pharmacodynamics data.

“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 at Veralox,” said Michael Hanna, Chief Medical Officer at Veralox.  “We look forward to continuing our development of VLX-1005 to address the underlying pathology of HIT, a disease that has not seen innovation in available therapies in over 20 years.”

The FDA previously granted Orphan Drug designation to VLX-1005 for this indication.

Reference

Veralox Therapeutics announces favorable results of phase 1 studies of VLX-1005 in development for treatment of heparin-induced thrombocytopenia. News release. Veralox Therapeutics. Accessed June 13, 2022. https://www.prnewswire.com/news-releases/veralox-therapeutics-announces-favorable-results-of-phase-1-studies-of-vlx-1005-in-development-for-treatment-of-heparin-induced-thrombocytopenia-301566142.html