Baudax Bio Inc.’s lead clinical candidate, TI-168, has been awarded U.S. orphan drug designation by the FDA for the treatment of hemophilia A with inhibitors. TI-168 is a next-generation, factor VIII (FVIII)-specific regulatory T-cell (Treg) therapy designed to address hemophilia A in patients with FVIII inhibitors.
Krystal Biotech Inc. has received IND clearance from the FDA for KB-408 for the treatment of α1-antitrypsin deficiency (AATD). KB-408 is a modified, replication-defective, nonintegrating HSV-1-derived vector carrying two full-length copies of the serpin family A member 1 gene (SERPINA1) to enable expression of α1-antitrypsin (AAT).
Via Nova Therapeutics Inc. has received clearance of its IND application from the FDA for its influenza A nucleoprotein inhibitor, VNT-101. The novel investigational small molecule is directed against a novel target, the influenza A nucleoprotein, and is being developed for treatment of seasonal influenza A infection.
Hepagene Therapeutics Inc. has received FDA clearance of its IND application for HPG-7233 for the treatment of patients with nonalcoholic steatohepatitis (NASH) and dyslipidemia.
Lantern Pharma Inc. has received FDA clearance of its IND application for LP-284, being developed for the treatment of relapsed or refractory non-Hodgkin lymphoma (NHL), including mantle cell lymphoma, double hit lymphoma and other high-grade B-cell lymphomas. Enrollment in a first-in-human phase I trial is expected to begin during the fourth quarter of this year.
Lapix Therapeutics Inc. has received IND clearance from the FDA to initiate a phase I trial of its first-in-class, immune tolerance restoration small molecule, LPX-TI641, for the treatment of multiple sclerosis (MS).
Contrafect Corp. has submitted an IND application to the FDA for its intravenous antibacterial agent, CF-370, for treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
The FDA has cleared an IND application for ADEL-Y01, being jointly developed by Oscotec Inc. and Adel Inc., for the treatment of Alzheimer’s disease. A phase Ia/b study will include healthy volunteers, and participants with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease.
Eikon Therapeutics Inc. has received IND clearance from the FDA to initiate phase I studies with IMP-1734, a highly selective poly(ADP-ribose) polymerase 1 (PARP-1) inhibitor developed in partnership with Impact Therapeutics Inc.
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