Business
Aclaris Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides R&D and Business Highlights
Positive Preliminary Results from Phase 1 Single and Multiple Ascending Dose Trial of ATI-450, an Investigational Oral MK2 InhibitorProjected Cash Runway into
About this update from Aclaris Therapeutics, Inc.
[{"type":"text","content":"Positive Preliminary Results from Phase 1 Single and Multiple Ascending Dose Trial of ATI-450, an Investigational Oral MK2 InhibitorProjected Cash Runway into the Third Quarter of 2021Management to Host Conference Call at 5:00 PM ET today WAYNE, Pa., Feb. 25, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced its financial results for the fourth quarter and full year 2019 and provided research and development (R&D) and business highlights.\n “In 2019, we repositioned the company to focus on our core competency in developing small molecule kinase inhibitors. Thus far, we are very pleased with the progression of our immuno-inflammatory pipeline, as well as with the positive results from our Phase 1 clinical trial of ATI-450, an oral small molecule MK2 inhibitor,” said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. “We look forward to initiating a Phase 2a trial of ATI-450 in subjects with rheumatoid arthritis in the first half of this year and executing on our new business plan.” R&D Highlights: ATI-450: ATI-450 is an investigational oral small molecule MK2 inhibitor.ATI-450-PKPD-101: A Phase 1 single and multiple ascending dose (SAD/MAD) trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered ATI-450 in 77 healthy subjects. Preliminary data from this trial demonstrated that ATI-450: resulted in marked inhibition of TNFα, IL1β, IL8, and IL6;was generally well-tolerated at all doses tested in the trial. The most common adverse events (reported by 2 or more subjects who received ATI-450) observed during the trial were dizziness, headache, upper respiratory tract infection, constipation, abdominal pain, and nausea;had dose-proportional pharmacokinetics (PK) with a terminal half-life of 9-12 hours in the MAD cohort; andhad no meaningful food effect or drug-drug interaction with methotrexate. ATI-450-RA-201: Aclaris intends to initiate a Phase 2a clinical trial for ATI-450 in subjects with rheumatoid arthritis in the first half of 2020.Aclaris is also planning to initiate a Phase 2a clinical trial of ATI-450 for an additional immuno-inflammatory indication. ATI-1777: ATI-1777 is an investigational topical soft-Janus Kinase (JAK) inhibitor compound that ...