Benzinga | Oct 4, 2021 08:11AM EDT

Inhibikase Therapeutics Announces Interim Three-month Results From Chronic Toxicology Studies Of Oral c-Abl Kinase Inhibitor, IkT-148009, In Development For Treatment Of Parkinson's Disease

Inhibikase Therapeutics, Inc. (NASDAQ:IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced interim three-month results from its ongoing chronic toxicology studies of oral IkT-148009 administered in rats and non-human primates (NHPs).

The Company's ongoing toxicology studies of IkT-148009 are designed to meet the regulatory requirements for chronic dosing in humans, which include daily oral administration in rats for six months and in NHPs for nine months. In addition to these requirements, Inhibikase has added three-month dosing cohorts in rats and NHPs to support evaluation in Parkinson's patients for up to three months in its planned Phase 2a study. Today's update includes interim results at three months from both animal species, across which the toxicology profile for IkT-148009 improved the longer the drug was dosed.

"As a highly selective kinase inhibitor, IkT-148009 has demonstrated it is distinct in its ability to discriminate against the target enzyme, c-Abl, without engaging other targets in the Abelson enzyme family, including c-KIT and PDGFRa-b. We believe this property may enable IkT-148009 to offer best-in-class safety, avoiding the most harmful side-effects commonly associated with c-Abl inhibitors the longer they are dosed in patients," stated Milton H. Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics. "We are pleased to share interim data from ongoing chronic toxicology studies that support this hypothesis, indicating a more favorable profile in rats and non-human primates given extended treatment with IkT-148009. These learnings, coupled with the absence of clinically significant adverse events in our Phase 1 study, add to our growing confidence in the safety and tolerability of IkT-148009. Taken together with efficacy signals observed preclinically, we look forward to evaluating IkT-148009 in a planned Phase 2a study, subject to FDA agreements, to see how this profile translates into patients with Parkinson's disease."

Inhibikase previously submitted 14-day toxicology data in rats and NHPs to the U.S. Food and Drug Administration (FDA) prior to initiating the Company's Phase 1 trial of IkT-148009 in older healthy subjects. In the 14-day study, the No Adverse Event Level (NOAEL), a measure of drug safety in animals, was determined to be 31.2 mg in NHPs, but could not be determined in rats. Following three months of dosing, NOAEL measurements in rats and NHPs were 50 mg and 75 mg, respectively, representing a 2.4-fold increase in NHPs and establishing a standard for rats.

Following FDA review of these three-month toxicology results, and subject to agreement with the Agency, the Company plans to initiate a Phase 2a study in 2022 to evaluate daily oral administration of IkT-148009 in up to 120 Parkinson's patients out to three months.