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Shares of Aclaris Therapeutics Inc. exploded 220% after the biopharma company released “positive” data from the Phase 2a trial of its investigational therapy for the treatment of moderate to severe rheumatoid arthritis (RA).
Aclaris (ACRS) reported that the Phase 2a, randomized, placebo-controlled clinical trial of ATI-450, its investigational oral MK2 inhibitor, met the primary endpoint of safety and tolerability, according to preliminary topline data. The 12-week study enrolled 19 patients, who received either ATI-450 at 50 mg twice daily or placebo, in combination with methotrexate. Aclaris is a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases. ATI-450 is an investigational oral mitogen-activated protein kinase-activated protein kinase 2 (MK2) inhibitor, which Aclaris is developing as a potential treatment for rheumatoid arthritis and other immuno-inflammatory illnesses.
“We’re very pleased with these data which demonstrate that ATI-450 was generally well tolerated and showed durable clinical activity in RA over 12 weeks,” said Aclaris Chief Medical Officer David Gordon. “We believe these data support our hypothesis that MK2 inhibition is an important novel target for the treatment of immuno-inflammatory diseases, such as rheumatoid arthritis, and we look forward to progressing ATI-450 to Phase 2b.”
Going forward, Aclaris will submit a full analysis of the Phase 2a data for publication in a peer-reviewed scientific journal. The full analysis will include data from other secondary and exploratory endpoints evaluated in the trial, including the four-week safety follow-up data and a full analysis of MRI, pharmacodynamic and pharmacokinetic data, the company said.
In a separate statement, Aclaris announced that it plans to offer a share sale to the public. As part of the offering, the company intends to grant the underwriters a 30-day option to buy up to an additional 15% of the shares of its common stock on the same terms and conditions. (See ACRS stock analysis on TipRanks)
Commenting on the preliminary data, William Blair analyst Tim Lugo believes that the "strong and consistent results across all efficacy measures are compelling" and pave the ground for a "promising efficacy profile."
Lugo reiterated a Buy rating on the stock as he argues that the results could be "transformational for Aclaris."
The analyst views ATI-450 as "a compelling pipeline-in-a-product candidate," which has the potential to be used in a "range of potentially blockbuster indications."
Aclaris scores a 9 out of 10 on Tipranks’ Smart Score rating, indicating that the stock has strong potential to outperform market expectations.
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