Inhibikase Therapeutics (IKT) Received FDA Clearance to Begin Phase 1b Trial of IkT-148009 in Parkinson's Patients

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced that, after a review of safety, tolerability and pharmacokinetic data from the Company's Phase 1 clinical trial of IkT-148009 in healthy volunteers, the United States Food and Drug Administration (FDA) has given the Company clearance to begin a Phase 1b extension study to evaluate its lead drug candidate IkT-148009 in Parkinson's patients.

The randomized Phase 1 study investigated the safety, tolerability and pharmacokinetics (PK) of IkT-148009 in healthy volunteers aged 45 to 70 years old, with the objective of evaluating the safety, tolerability and the PK profile of IkT-148009 in single and multiple ascending dose settings. Forty-two patients were dosed with IkT-148009 between 12.5 and 100 mg with no clinically significant adverse events reported. High drug exposures were achieved in this dose range and were consistent with exposures observed in animal efficacy studies of inherited and sporadic progressive Parkinson's disease. Following the review, the Agency met with the Company on July 22, 2021, and granted the company permission to begin evaluation of IkT-148009 in Parkinson's patients.

"The extension of our Phase 1 study of IkT-148009 for the treatment of Parkinson's disease into patients is an important milestone for Inhibikase. IkT-148009 is a highly selective, potent inhibitor of the Abelson Tyrosine Kinase, or c-Abl, which plays a critical role in driving neurodegeneration and neuroinflammation in Parkinson's disease," stated Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics. "In validated preclinical animal models, IkT-148009 was able to drive functional recovery in the brain and gastrointestinal tract, clear pathologic alpha-synuclein aggregates, and block neurodegeneration and neuroinflammation. With the initiation of our Phase 1b extension study in Parkinson's patients, we are excited that we may be closer to finally impacting this devastating disease that affects millions of people worldwide."

You May Also Be Interested In

• Alvotech (ALVO) receives FDA approval for Selarsdi for moderate to severe plaque psoriasis
• Amplitech Group Inc. (AMPG) Files F-3 Shelf To Replace Expired Shelf
• Zevra Therapeutics (ZVRA) Presents New Data on the Long-Term Safety and Efficacy of Arimoclomol as a Treatment for Niemann-Pick Disease Type C