On Wednesday, Aclaris Therapeutics (NASDAQ:ACRS) commenced a Phase 2a clinical trial for ATI-2138, an oral covalent inhibitor aimed at treating moderate-to-severe atopic dermatitis (AD). The study is designed to enroll approximately 15 patients within the United States, who will undergo treatment with ATI-2138 over a 12-week period.
BTIG has reiterated its Neutral rating on Aclaris Therapeutics, indicating a wait-and-see approach as the company progresses through the clinical trial phases.
The decision to proceed to a Phase 2a trial follows the completion of a Phase 1 multiple ascending dose (MAD) study conducted late last year. During this initial phase, significant inhibition of ITK and JAK3 enzymes was observed with a twice-daily 5mg dose of ATI-2138. A higher 15mg dose resulted in near-complete pathway inhibition, suggesting potential for efficacy at the Phase 2a trial dose of 10mg administered twice daily.
ATI-2138's dual mechanism of action, targeting both the ITK and JAK3 pathways, is anticipated to enhance its efficacy. This is due to the expected inhibition of the differentiation and activation of Th2 and Th17 cells, which are implicated in the pathophysiology of atopic dermatitis. The broader activity of ATI-2138 could potentially offer advantages over other treatments that have less pleiotropic mechanisms of action, such as dupilumab.
BTIG is closely monitoring the trial's developments, with topline data expected to be released in the first half of 2025. This data will be crucial in determining the future potential of ATI-2138 as a treatment option for AD.
In other recent news, Aclaris Therapeutics has sold a portion of its future royalty earnings from the sale of OLUMIANT, a treatment for alopecia areata, to OMERS, a Canadian pension plan. The deal includes an upfront payment of $26.5 million to Aclaris, with the potential for an additional $5.0 million, contingent on specific sales milestones in 2024. OMERS now holds a share of the royalties from Eli Lilly and Company (NYSE:LLY)'s worldwide net sales of OLUMIANT beginning April 2024.
In parallel, Aclaris is conducting a strategic review of its business to identify additional investment opportunities that complement its drug development pipeline. Cantor Fitzgerald & Co. and DLA Piper LLP (US) advised Aclaris on this transaction, while Davies Ward Phillips & Vineberg LLP advised OMERS.
In other developments, Aclaris has advanced ATI-2138, an oral small molecule inhibitor, into a Phase 2 proof-of-concept study following positive results in a Phase 1 study. Financially, the company reported a robust cash position of $161 million and is focusing on cost containment and non-dilutive funding strategies. These are recent developments, with further updates expected.
InvestingPro Insights
As Aclaris Therapeutics (NASDAQ:ACRS) moves forward with its Phase 2a trial for ATI-2138, it's important to consider the company's financial health and market performance. According to InvestingPro data, Aclaris Therapeutics holds a market capitalization of approximately $83.83 million. Despite this relatively modest size, the company has shown a significant quarterly revenue growth of 47.99% in the last twelve months as of Q2 2024. This is a positive sign, indicating the potential for growth and expansion, particularly if ATI-2138 proves successful in clinical trials.
InvestingPro Tips reveal that analysts have revised their earnings upwards for the upcoming period, suggesting that the market is optimistic about the company's future performance. Additionally, Aclaris holds more cash than debt on its balance sheet, which is an encouraging sign of financial stability. This liquidity may provide the company with the flexibility to navigate the costly process of drug development and clinical trials.
On the other side, it is noted that Aclaris is quickly burning through cash, which could be a concern as it invests heavily in research and development for its pipeline, including ATI-2138. Analysts also anticipate a sales decline in the current year and do not expect the company to be profitable this year. These factors underscore the importance of the successful development of ATI-2138 and other pipeline drugs for the company's future.
For those interested in a deeper dive into Aclaris Therapeutics' financials and market performance, InvestingPro offers additional tips and insights. There are 10 more InvestingPro Tips available at https://www.investing.com/pro/ACRS, which could provide investors with a more comprehensive understanding of the company's prospects and potential investment opportunities.
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