Inhibikase Therapeutics announces outcomes of pre-NDA meeting with FDA

Inhibikase Therapeutics,announced preliminary outcomes of the company’s discussion with the FDA on the path to approval of IkT-001Pro in blood and stomach cancers, the Company’s prodrug of the anticancer agent imatinib mesylate. On February 12, the FDA Review Team from the Division of Hematologic Malignancies issued final meeting minutes from the pre-NDA video conference that took place January 19. In the minutes, the FDA noted that it may not be necessary to conduct a formal use-related risk analysis of medication errors due to the company proposing dosage forms that would not overlap with those of imatinib mesylate. In the NDA package, the Company will have to justify why its alternate dosage forms could overcome the risk of dosing errors by physicians and patients. Following the discussion with the Review Team about possible differences in the way IkT-001Pro and imatinib mesylate are absorbed in the gut, the FDA agreed with the Company’s assertion that a pre-clinical analysis of gut absorption should be performed to determine whether a food effect clinical study is warranted, since the Company’s clinical measures were all performed using an FDA-approved meal prior to taking IkT-001Pro or imatinib mesylate. While the Company will have to supply data and/or rationale for use of IkT-001Pro in any indication for which imatinib mesylate is approved, use in children will need to be accompanied by a statutory planning document related to dose adjustments and use in children of different ages and/or weights. This planning document is required for any product in which use in children is proposed. All other elements of the pre-NDA meeting remain unchanged from those reported on February 7. The company continues to explore additional indications for which imatinib delivered by IkT-001Pro could be useful and has an upcoming meeting with the FDA to discuss cardiopulmonary applications of IkT-001Pro in April.