Aclaris Says FDA Clears IND To Evaluate ATI-450 MK2 Inhibitor - Quick Facts

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.

The trial is a Phase 2a, randomized, double-blind, placebo-controlled trial to investigate the safety and efficacy of ATI-450, when used in addition to standard of care therapy. The primary endpoint is the proportion of subjects who are free from respiratory failure by day 14.

ATI-450 is an investigational oral mitogen-activated protein kinase-activated protein kinase 2 (MK2) inhibitor in Phase 2 clinical development.

ATI-450 has been observed to regulate pro-inflammatory cytokines associated with CRS. Pharmacodynamic analysis from the first-in-human study using an ex vivo lipopolysaccharide (LPS) stimulation model demonstrated dose-dependent reduction of TNFa, IL1ß, IL6 and IL8.

Further analysis using this LPS model showed marked inhibition of additional cytokines linked to CRS, including GM-CSF, IL2, IFN? and MIP1a. The anti-inflammatory activity for ATI-450 was also observed in a rat model of airway neutrophilia induced by inhaled LPS. In addition, anti-viral and anti-fibrotic activity has been observed following blockade of the MK2 pathway in preclinical studies.

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