Aclaris Therapeutics Inc. (ACRS:NASDAQ) today announced "positive preliminary topline results from a 12-week, Phase 2a, multicenter, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled clinical trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450, an investigational oral MK2 inhibitor, in subjects with moderate to severe rheumatoid arthritis (RA) (ATI-450-RA-201)." The company pointed out that it had created ATI-450 using its proprietary KINect™ drug discovery platform.
Aclaris Therapeutics advised that the Phase 2a study included 19 subjects who were randomized over a period of 12 weeks to receive either a dose of 50 mg twice daily ATI-450 or a placebo, in combination with methotrexate. The company stated that the Phase 2a proof of concept trial's primary endpoint was to determine the safety and tolerability of ATI-450, but noted that the study was not structured in a manner to provide statistically significant outcomes regarding efficacy endpoints. The firm noted that in addition, "key secondary and exploratory endpoints included the disease activity scores, DAS28-CRP and ACR20/50/70 and the change from baseline in high sensitivity C-reactive protein (hsCRP) and relevant endogenous cytokine levels."
The firm indicated that 17 of the 19 patient subjects enrolled in the trial completed 12 weeks of treatment and reported that "the mean DAS28-CRP score at baseline was 5.71 for the 16 subjects in the treatment arm and 5.77 for the three subjects in the placebo arm." The company stated that these results show that "ATI-450 demonstrated durable clinical activity in the trial, as defined by a marked and sustained reduction in DAS28-CRP and evaluation of ACR20/50/70 responses over 12 weeks."
The company reported that ATI-450 was generally well tolerated in the trial and that no serious adverse events were reported. The firm added that ATI-450 was previously evaluated at higher doses in a separate Phase 1 clinical trial in healthy subjects (ATI-450-PKPD-102). The company noted that the Phase 1 trial patients received a higher twice daily dose of either 80mg or 120 mg of ATI-450 over 6.5 days, which was shown to have increased cytokine inhibition, and commented that no dose-limiting toxicity was observed in the study. The company stated that a final analysis of the results from this Phase 1 study data is currently underway.
Aclaris Therapeutics' Chief Medical Officer Dr. David Gordon commented, "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. 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. We want to thank everyone who participated in these informative trials."
Stanley Cohen, M.D., clinical professor in the Department of Internal Medicine and a clinical faculty member in the Division of Rheumatology at UT Southwestern Medical School and a co-director of the Division of Rheumatology at Presbyterian Hospital in Dallas, remarked, "Despite recent advances, rheumatoid arthritis continues to be a significant burden for large numbers of patients...These results are very encouraging and support further development of ATI-450 to treat rheumatoid arthritis with a new mechanism of action."
Aclaris Therapeutics is a clinical-stage biopharmaceutical company based in Wayne, Penn., that is engaged in creating a pipeline of new medicines address the unmet needs of patients with immuno-inflammatory diseases. The firm has built a multi-stage portfolio of drug candidates utilizing its proprietary KINect™ technology platform and drug discovery expertise to apply kinase inhibition to develop novel, small molecule therapies for treatment of immuno-inflammatory conditions. The company states on its website that "the ability to systemically and efficiently attach human kinases with adenosine triphosphate site cysteines (the human cysteinome) differentiates Aclaris from competitors." The firm's wholly owned subsidiary Confluence Discovery Technologies Inc. operates as an independent full-service drug discovery and early development contract research organization that provides research services to pharmaceutical and biotech companies in the areas of therapeutics and genomics.
Aclaris Therapeutics started off the day with a market capitalization of around $252.4 million with approximately 42.92 million shares outstanding and a short interest of about 1.6%. ACRS shares opened nearly 140% higher today at $14.05 (+$8.17, +138.95%) over Friday's $5.88 closing price and reached a new 52-week high this morning of $19.80. The stock has traded today between $13.29 to $19.80 per share and is currently trading at $17.43 (+$11.55, +196.43%).
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