Aclaris Therapeutics, Inc. (ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, today announced that it has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for ATI-450, an oral MK2 inhibitor, for the treatment of rheumatoid arthritis (RA). If the IND is allowed by the FDA, Aclaris plans to initiate a Phase 1 clinical trial of ATI-450 in the second half of 2019.
We are very pleased to have this IND under review by the FDA, said Dr. Neal Walker, President & Chief Executive Officer of Aclaris. We look forward to beginning the development of ATI-450 as a potential treatment for rheumatoid arthritis and other potential indications driven by TNF, IL-1, IL-6, or IL-8. We believe there is an important need to provide additional treatment options for rheumatoid arthritis to improve overall patient care.
ATI-450, an investigational medicine formerly known as CDD-450, would be the first novel compound created by Confluence Discovery Technologies, Inc., our indirect wholly owned subsidiary, to enter the clinical phase of development. Aclaris plans to initiate a Phase 1 single ascending dose study of safety, tolerance, and pharmacokinetics followed by several cohorts of multiple ascending doses. Aclaris is actively considering additional indications for clinical testing in the future.
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