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First Subject Dosed in Phase 2a Trial of ATI-450, an Investigational Oral MK2 Inhibitor, as a Potential Treatment for Moderate to Severe Rheumatoid Arthritis
First Subject Dosed in Phase 2a Trial of ATI-450 for Cytokine Release Syndrome in Hospitalized Patients with COVID-19
Clinical Trial of ATI-1777, an Investigational Soft Topical JAK 1/3 Inhibitor, to Proceed in Patients with Moderate to Severe Atopic Dermatitis
Aclaris Therapeutics Reports Second Quarter 2020 Financial Results and Provides R&D and Business Highlights
Aclaris Therapeutics, Inc. GlobeNewswireAugust 7, 2020
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R&D Highlights:
The global outbreak of COVID-19 continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its regulatory and research and development activities listed below.
- ATI-450, an investigational oral small molecule MK2 inhibitor compound:
- ATI-450-RA-201: An ongoing Phase 2a trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in subjects with moderate to severe rheumatoid arthritis.
- This trial was initiated in March 2020. Due to the COVID-19 pandemic, Aclaris temporarily paused enrollment. Aclaris resumed enrolling subjects, and the first subject was dosed, in May 2020. At this time, Aclaris is actively recruiting for this trial. Given the continuing evolution of the COVID-19 pandemic, Aclaris now anticipates reporting data from this trial in the first half of 2021.
- ATI-450-CAPS-201: Aclaris expects to initiate a Phase 2a clinical trial of ATI-450 in cryopyrin-associated periodic syndrome (CAPS), an IL1β-driven disease, in the second half of 2020.
- IIT-2020-ATI-450-COVID-19: An ongoing investigator-initiated Phase 2a, randomized, double-blind, placebo-controlled clinical trial to investigate 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 36 hospitalized patients with COVID-19. Aclaris is providing funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial. The primary endpoint in this trial is the proportion of subjects who are free from respiratory failure by day 14.
- The first subject was dosed in August 2020.
- ATI-1777, an investigational topical soft Janus Kinase (JAK) 1/3 inhibitor compound:
- Aclaris submitted an Investigational New Drug (IND) Application for ATI-1777 for the treatment of moderate to severe atopic dermatitis (AD) in June 2020 and now plans to progress to the first-in-human trial of ATI-1777 in subjects with moderate to severe AD.
- ATI-1777-AD-201: Aclaris expects to initiate a Phase 1/2a multicenter, randomized, double-blind, vehicle-controlled trial to investigate the safety, tolerability, pharmacokinetics and efficacy of topically applied ATI-1777 in subjects with moderate to severe AD in the second half of 2020. The primary endpoint will assess efficacy at four weeks.
- ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
- Aclaris is developing ATI-2138 as a potential treatment for psoriasis and/or inflammatory bowel disease and expects to submit an IND for ATI-2138 in 2021.
Business Development Highlights:
- Aclaris continues to pursue strategic alternatives, including seeking partners for:
- A-101 45% Topical Solution: to obtain regulatory approval and commercialize A-101 45% Topical Solution, an investigational compound, as a potential treatment for common warts (verruca vulgaris);
- ATI-501 & ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 (oral) and ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as potential treatments for alopecia; and
- ESKATA: to commercialize ESKATA® (hydrogen peroxide) topical solution, 40% (w/w).
https://finance.yahoo.com/news/aclaris-therapeutics-reports-second-quarter-110000807.html?guce_referrer=aHR0cHM6Ly9maW5hbmNlLnlhaG9vLmNvbS9xdW90ZS9BQ1JTP3A9QUNSUyZndWNlX3JlZmVycmVyPWFIUjBjSE02THk5bWFXNWhibU5sTG5saGFHOXZMbU52YlM5eGRXOTBaUzlCUTFKVFAzQTlRVU5TVXcmZ3VjZV9yZWZlcnJlcl9zaWc9QVFBQUFJaGJkWldWel9DYnItOXpSNzlRVF9UdEdOQUo1blVxaHFCVFFOYVRTcWJwSW5XbTNqclRySDlkNWtVRUUwZHotamN6ancwQzZwTVpfM1BZR3dUemk2ckM0TW5hZjVKNWRYMTJSTEcza0N4ak9YRHdqQnotVXJ6SW9hSnYzX3VOMHMzNVFlYUlNTktpbzA5MHNILTA4eDljMnA2bTZub2tyems3WlMzZmF0UlUmX2d1Y19jb25zZW50X3NraXA9MTU5NzA2NzE5Ng&guce_referrer_sig=AQAAALheF0dImmwxQJqLNmUbnFSb88NiCQdOU9UmSq4gGnHtjfuWJpX5Wuf51vt7QMJXDg7KJYZ5tkHOiVy4Zam0KZMSasjsJM-eKsxlFxKp02-Gatfj74LTnZhoyUqFf4tg_dBicbFiwdHpqc-ZFohWshWfuNL2jprjNGK7luqBMNhp&_guc_consent_skip=1597068326
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