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Aclaris' MK2 Inhibitor Shows Encouraging Data in Phase I

Aclaris Therapeutics, Inc. ACRS announced positive data from the phase I ATI-450-PKPD-101 study on it investigational MK2 inhibitor, ATI-450, currently being developed for addressing immuno-inflammatory diseases.

The single ascending dose and multiple ascending dose (SAD/MAD) clinical study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered ATI-450 in healthy patients.

Preliminary data from the study showed that treatment with ATI-450 led to marked inhibition of key inflammatory cytokines, such as TNFα, IL1β, IL8, and IL6 and was generally well-tolerated across all-dose level tested. No serious side effects were reported from the same.

Importantly, preliminary data from the study supports progression to a phase IIa proof-of-concept studies for immuno-inflammatory diseases. Aclaris plans to initiate a phase II study for treating rheumatoid arthritis in the first half of this year.

Shares of Aclaris rallied 17.2% following this announcement. However, the stock has plunged 68.2% in the past year against the industry’s rise of 0.8%.

 

We remind investors that in October 2019, Aclaris sold the worldwide rights to its rosacea drug Rhofade Cream and certain licenses to its related intellectual property assets to privately-held, specialty pharmaceutical company EPI Health for $55 million. The divestiture is part of Aclaris’ ongoing restructuring program to focus on its immuno-inflammatory pipeline.

Notably, Aclaris acquired the rights to Rhofade from Allergan AGN in 2018.

The company is currently developing its pipeline candidate, A-101 45% topical solution for the treatment of common warts in two late-stage studies. The candidate met the primary and all secondary efficacy endpoints, achieving clinically and statistically significant clearance of common warts in both phase III studies of THWART-1 and THWART-2.

This apart, Aclaris has two JAK inhibitors, namely ATI-501 and ATI-502 in mid-stage development for the treating alopecia. The company had in-licensed these two candidates from Rigel Pharmaceuticals, Inc, RIGL in 2015. It has several other pre-clinical candidates in its portfolio.

Zacks Rank & Key Pick

Aclaris currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Karyopharm Therapeutics Inc. KPTI, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Karyopharm’s loss per share estimates have narrowed 0.5% for 2020 over the past 60 days. The stock has surged 89.6% in the past year.

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