"Aclaris anticipates that its cash, cash equivalents and marketable securities as of December 31, 2019, will be sufficient to fund its operations into the third quarter of 2021, without giving effect to any potential business development transactions or financing activities."
Aclaris Says FDA Clears IND To Evaluate ATI-450 MK2 Inhibitor - Quick Facts
Jun. 17, 2020, 01:35 PM
(RTTNews) - Clinical-stage biopharmaceutical company Aclaris Therapeutics, Inc. (ACRS) announced Wednesday that the U.S. Food and Drug Administration (FDA) has allowed an investigational new drug (IND) application to evaluate ATI-450, its oral investigational MK2 inhibitor compound, in hospitalized patients with COVID-19.
Aclaris is supporting an investigator-initiated trial of ATI-450 for cytokine release syndrome (CRS) in 36 hospitalized patients with COVID-19, and will provide funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial.
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Aclaris Therapeutics Submits Investigational New Drug Application for ATI-1777, a Topical “Soft” JAK1/3 Inhibitor, for the Treatment of Moderate to Severe Atopic Dermatitis
WAYNE, Pa., July 07, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (ACRS), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates for immuno-inflammatory diseases, today announced that it has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for ATI-1777, an investigational topical “soft” Janus kinase (JAK) 1/3 inhibitor, for the treatment of moderate to severe atopic dermatitis (AD). ATI-1777 is another compound generated from the Aclaris KINect™ drug discovery platform, and was specifically developed as a topical “soft” drug.
Aclaris is supporting an investigator-initiated trial of ATI-450 in 36 hospitalized patients with COVID-19, and will provide funding and the clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial located in Kansas City, Kansas.
The clinical trial is underway to treat patients with the novel coronavirus because COVID-19 can cause acute respiratory distress syndrome, ARDS.
“Literature that’s come out over the last four or five months suggests one of the causes of ARDS is a hyperactive immune response, so the immune system is triggered when you get the viral infection, but for some reason the immune system goes a little haywire and this results in an inflammatory state,” explained Monahan. “The data suggests that this inflammatory state, this hyperinflammation, is associated with an upregulation of certain proteins that come from both diseased tissue and immune cells, called cytokines. And these cytokines could be the culprit in driving this ARDS and the inflammation seen in the lung in COVID-19 patients.”
Monahan explained the reason it’s believed ATI-450 will work as a rheumatoid arthritis treatment is because the drug downregulates cytokines, inhibiting their production.
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
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.
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).