Aclaris Therapeutics Secures FDA Clearance for ATI-052 Clinical Trial

Aclaris Therapeutics Secures FDA Clearance for ATI-052 Clinical Trial

WAYNE, PA — Aclaris Therapeutics, Inc. (NASDAQ: ACRS) has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for ATI-052, a bispecific monoclonal antibody targeting immuno-inflammatory diseases. The FDA clearance allows the company to proceed with a Phase 1a/1b clinical trial, anticipated to begin in the second quarter of 2025. ATI-052 is designed to inhibit key proinflammatory …

Ensem Therapeutics' application for ETX-636 secures FDA clearance

This allosteric pan-mutant-selective phosphatidylinositol 3-kinase alpha (PI3Kα) inhibitor and degrader is poised to enter first-in-human trials in the second quarter of this year. According to the company, mutant The post Ensem Therapeutics’ application for ETX-636 secures FDA clearance appeared first on Pharmaceutical Business review.

Aclaris Therapeutics receives FDA approval for Phase Ia/Ib trial of ATI-052

The US FDA has cleared the IND application of Aclaris to commence the placebo-controlled Phase Ia/Ib study of the ATI-052 antibody.The post Aclaris Therapeutics receives FDA approval for Phase Ia/Ib trial of ATI-052 appeared first on Clinical Trials Arena.

FDA clears Aclaris’ IND application for ATI-052 trial - BioTuesdays

Aclaris Therapeutics (NASDAQ:ACRS) announced that the FDA has cleared its Investigational New Drug (IND) application for a Phase 1a/1b trial of ATI-052—expected to launch in Q2 of this year. According to Aclaris, the trial will evaluate single and multiple doses of ATI-052, a potential best-in-class bispecific anti-TSLP/IL-4R monoclonal antibody. A proof-of-concept portion in an undisclosed indication will follow the trial. In a statement, Dr. H…