IKT Stock: Why It Increased Today

By Amit Chowdhry ● Oct 4, 2021
  • The stock price of Inhibikase Therapeutics, Inc. (Nasdaq: IKT) increased over 5% pre-market today. This is why it happened.

The stock price of Inhibikase Therapeutics, Inc. (Nasdaq: IKT) – a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders – increased over 5% pre-market today. Investors are responding positively to the company announcing 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 9 months. In addition to these requirements, And Inhibikase has added 3-month dosing cohorts in rats and NHPs to support evaluation in Parkinson’s patients for up to 3 months in its planned Phase 2a study. This update includes interim results at 3 months from both animal species, across which the toxicology profile for IkT-148009 improved the longer the drug was dosed.

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. And 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 3 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 3-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 3 months.

KEY QUOTE:

“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. 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.”

— Milton H. Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics

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