The FDA Reviews Inhibikase Therapeutics Inc’s (NASDAQ: IKT) Investigative New Drug Application For IkT-001Pro in CML Treatment

Inhibikase Therapeutics Inc (NASDAQ: IKT) has announced a review of its Investigative New Drug application by the FDA for IkT-001Pro for Chronic Myelogenous Leukemia (CML) treatment. Also, the regulatory agency has granted the company a Study May Proceed letter.

IkT-001Pro was developed to increase imatinib’s safety. 

IkT-001Pro, a drug carrier version of imatinib mesylate, was created to increase the efficacy of imatinib (commercially known as Gleevec), the first Abelson (Abl) kinase blocker to receive FDA approval. Imatinib is frequently used to treat gastrointestinal and hematological malignancies that develop as a result of c-Kit, PDGFRa/b, or Abl kinase alterations discovered in bone marrow, in addition to gastrointestinal malignancies that develop as a result of changes in the gut’s c-Kit and/or PDGFRa/b proteins. IkT-001Pro could be a more secure treatment option for patients and increase the proportion of those with stable-phase CML who achieve and maintain substantial and/or full cytogenetic reactions.

IkT-001Pro has been demonstrated in preclinical trials to be up to 3.4 times better than imatinib in animal studies, minimizing onerous gastrointestinal adverse effects which precede oral delivery. Imatinib administered as IkT-001Pro received Orphan Drug Designation in September 2018 for stable-phase Chronic Myelogenous Leukemia.

IkT-001Pro, the first program from Inhibikase’s prodrug platform 

CEO Milton Werner said, “We are excited to have received the SMP letter from the FDA for IkT-001Pro for CML. This represents the first program to emerge from our novel prodrug platform, which aims to improve the safety and tolerability of approved and novel therapeutics.”

According to preclinical research, the company thinks IkT-001Pro could considerably enhance oral imatinib’s safety profile, improving patient compliance and life quality and possibly resulting in higher overall cytogenetic response rates. The company expects to commence its bioequivalence study in  2H 2022.

The company plans to evaluate IkT-001Pro in the single ascending dosage bioequivalence study that will enroll subjects aged between 25 and 55. Each subject shall receive IkT-001Pro at 1 of 4 doses. The objective of the study will be to assess IkT-001Pro’s safety profile and find a dosage with a comparable pharmacokinetic profile.