WILMINGTON, DE — Inhibikase Therapeutics Inc. (Nasdaq: IKT) has enrolled the first patient in its Phase 3 clinical trial evaluating IKT-001 for pulmonary arterial hypertension, advancing development of the drug candidate for a progressive cardiovascular condition.
The study, known as IMPROVE-PAH, is a global Phase 3 trial designed to assess the drug’s impact on pulmonary vascular resistance and other clinical outcomes.
IKT-001 is an oral prodrug of imatinib mesylate intended to reduce gastrointestinal side effects associated with the underlying compound.
Chief Executive Officer Mark Iwicki said the trial design is intended to support a single pivotal study and accelerate potential regulatory submission.
“Enrollment of the first patient in our IMPROVE-PAH trial is a major milestone,” Iwicki said.
The trial will be conducted in two parts, beginning with a double-blind, placebo-controlled study of approximately 140 patients, measuring changes in pulmonary vascular resistance at 24 weeks.
A second phase will enroll about 346 patients and evaluate changes in six-minute walk distance, a common measure of functional capacity in patients with pulmonary arterial hypertension.
The study includes a 12-week dose-titration period and allows for adjustments to sample size based on early results.
Investigators said the trial is designed to evaluate both hemodynamic measures and functional outcomes, including disease progression.
“The Phase 3 IMPROVE-PAH study will help evaluate both hemodynamic and functional improvements,” said Dr. Harrison Farber of Tufts Medical Center.
Dr. J. Wesley McConnell of Norton Pulmonary Specialists said the trial is structured to measure outcomes relevant to patients and clinicians.
“The IMPROVE-PAH trial represents a meaningful step forward,” McConnell said.
Pulmonary arterial hypertension affects approximately 50,000 people in the United States and is characterized by increased pressure in the pulmonary arteries and progressive vascular damage.
The trial is expected to enroll patients at up to 180 sites worldwide.
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