BOSTON and ATLANTA - Inhibikase Therapeutics, Inc. (NASDAQ:IKT), a clinical-stage pharmaceutical firm, has reported progress in discussions with the U.S. Food and Drug Administration (FDA) regarding the approval path for its drug IkT-001Pro, intended for blood cancer treatment. The company's President and CEO, Dr. Milton Werner, expressed satisfaction with the FDA's guidance on manufacturing requirements for their New Drug Application (NDA).
During a meeting on January 19, 2024, the FDA indicated that the 505(b)(2) approval pathway seems fitting for IkT-001Pro, a prodrug of imatinib mesylate. The preliminary outcomes suggest that IkT-001Pro's 600 mg and 800 mg dosages provide similar exposure to 400 mg and 600 mg of imatinib mesylate. These findings are awaiting formal review within the NDA package.
Inhibikase aims to seek approval for all 11 indications for which imatinib mesylate has been approved, including pediatric use. The company is also initiating pre-clinical tests to evaluate IkT-001Pro's absorption in the gut and ensure its equivalence to imatinib mesylate. Additionally, efforts are being made to prevent confusion between IkT-001Pro and imatinib mesylate at pharmacies and among patients by differentiating the drugs in appearance, pill size, and dosage.
The company is also making strides in its 201 Trial, evaluating risvodetinib for untreated Parkinson's disease. As of today, 32 sites are actively recruiting participants, with 51 enrolled, 19 in medical screening, and 46 being evaluated for screening eligibility. Out of those who have completed the 12-week dosing period, there have been reports of nine mild and one moderate treatment-related adverse events.
IkT-001Pro, designed to enhance the safety of imatinib, has shown promise in preclinical studies, potentially offering a safer alternative for patients and improving treatment responses in Stable-Phase Chronic Myelogenous Leukemia.
This report is based on a press release statement from Inhibikase Therapeutics, Inc.
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