Aclaris Therapeutics, Inc. ( ACRS Quick Quote ACRS - Free Report) announced positive preliminary top-line data from a 12-week phase IIa study, which is evaluating its investigational oral MK2 inhibitor ATI-450 for treating moderate-to-severe rheumatoid arthritis (“RA”), an immuno-inflammatory disease. The multicenter, randomized, placebo-controlled study is investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 for the given indication.
Per the company, subjects were randomized in a 3:1 ratio in the above study and received either ATI-450 (50 mg twice daily) or placebo in combination with methotrexate for a period of 12 weeks. The primary endpoint of the study was to check the safety and tolerability, while secondary and exploratory endpoints included the disease activity scores and the change from baseline in high sensitivity C-reactive protein and relevant endogenous cytokine levels.
Notably, the above study was designed to generate proof of concept and was not powered to observe statistically significant outcomes on efficacy endpoints.
Data from the study showed that treatment with ATI-450 led to durable clinical activity over 12 weeks, which supports new oral approach for the potential treatment of RA and also supports progression to a phase IIb study on the same. The candidate was generally well tolerated with no serious adverse side effects being reported.
Shares of Aclaris soared 220.2% on Tuesday following the announcement of the news. In fact, the stock has skyrocketed 988.5% in the past year against the
industry’s decrease of 2.4%. We note that, apart from RA, Aclarisis is developing ATI-450 as a potential treatment for other immuno-inflammatory diseases.
An ongoing phase IIa study is evaluating the safety, tolerability, efficacy and pharmacodynamics of ATI-450 for the maintenance of remission in subjects with cryopyrin-associated periodic syndrome previously managed with anti-IL1 therapy.
Meanwhile, in June 2020, the FDA
allowed an investigational new drug application to evaluate ATI-450 in hospitalized patients with COVID-19.
A placebo-controlled phase IIa study is investigating the safety and efficacy of ATI-450, when used in addition to standard of care therapy, as a potential treatment for cytokine release syndrome in hospitalized patients with COVID-19. The primary endpoint of the study is to see the proportion of subjects who are free from respiratory failure by day 14.
A positive development of the candidate for any of the given indications will boost Aclaris’ growth prospects in the days ahead.
Zacks Rank & Stocks to Consider
Aclaris currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include
Infinity Pharmaceuticals, Inc. ( INFI Quick Quote INFI - Free Report) , United Therapeutics Corporation ( UTHR Quick Quote UTHR - Free Report) and BioLineRx Ltd. ( BLRX Quick Quote BLRX - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Infinity Pharmaceuticals’ loss per share estimates have narrowed 8.7% for 2021 over the past 60 days. The stock has skyrocketed 140% in the past year.
United Therapeutics’ earnings estimates have been revised 0.9% upward for 2021 over the past 60 days. The stock has rallied 86.8% in the past year.
BioLineRx’s loss per share estimates have narrowed 38.2% for 2021 over the past 60 days. The stock has increased 27.3% in the past year.
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