WILMINGTON, DE — Inhibikase Therapeutics, Inc. (Nasdaq: IKT) reported that it has secured regulatory clearance in 16 countries for its Phase 3 pulmonary arterial hypertension study, marking a key step in the company’s effort to advance its lead drug candidate toward potential registration.
The company recently announced that the European Medicines Agency authorized initiation of the IMPROVE-PAH trial across 12 European Union countries, adding to approvals already obtained in the United States, Canada, New Zealand, and Argentina.
The approvals come as Inhibikase begins enrolling patients in the global study evaluating IKT-001, an investigational treatment for pulmonary arterial hypertension, or PAH, a rare and progressive cardiovascular disease.
Chief Executive Officer Mark Iwicki said that the company recently enrolled the first patient in the study and has started activating clinical sites globally following the latest approvals.
“With the recent approvals obtained in the first 16 countries worldwide, Inhibikase is well-positioned to initiate clinical site activations and seek to advance enrollment of IMPROVE-PAH,” Iwicki stated.
The Phase 3 IMPROVE-PAH program uses a two-part adaptive trial design intended to evaluate both pulmonary vascular resistance and six-minute walk distance, a standard measurement of exercise capacity in PAH patients.
Part A of the study will enroll about 140 patients in a placebo-controlled trial measuring changes in pulmonary vascular resistance after 24 weeks. Part B is expected to enroll approximately 346 patients and will evaluate changes in six-minute walk distance over the same period.
The company said the trial structure allows uninterrupted enrollment between the two stages and includes the ability to reassess sample size requirements based on early findings.
Inhibikase also disclosed that it submitted an Orphan Drug Designation application to the U.S. Food and Drug Administration for IKT-001 in April. The designation is intended for treatments targeting rare diseases affecting relatively small patient populations.
The company declared cash, cash equivalents, and marketable securities totaling $170.4 million as of March 31.
Quarterly net loss widened to $16.4 million, or $0.10 per share, from $13.7 million, or $0.15 per share, during the same period a year earlier.
Research and development expenses totaled $10.8 million for the quarter, while selling, general, and administrative expenses rose to $7.4 million from $5.2 million a year earlier.
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