FYI - Inhibikase Therapeutics (IKT) is taking a stab at PD.
finance.yahoo.com/news/inhi...
Vandana Singh
February 17, 2021
Inhibikase Therapeutics Inc (NASDAQ: IKT) has dosed the first patients in its Phase 1 trial of IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, for the treatment of Parkinson's disease.
This randomized Phase 1 study in healthy volunteers will assess the safety, tolerability, and pharmacokinetics (PK) of IkT-148009 to identify the maximum tolerated dose in single and multiple ascending dose settings.
In preclinical animal models, the drug candidate demonstrated that once a day, oral therapy with IkT-148009 can halt and reverse the functional loss in the brain and gastrointestinal tract.
Activation of c-Abl, drives biochemical pathways and processes that lead to degradation of the neurons affected in Parkinson's disease. Inhibition of c-Abl may restore functional loss for neurons that have not fully degraded in the brain and remodel neurons in the gastrointestinal tract, two major organ systems affected by the disease.
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Update from May17, 2021
finance.yahoo.com/news/inhi...
Accelerated timelines for Phase 1 Study of IkT-148009 for the treatment of PD and associated GI Disorders: In February, 2021 Inhibikase commenced patient dosing in its Phase 1 study evaluating the safety, tolerability and pharmacokinetics of IkT-148009, the Company's novel brain penetrant Abelson tyrosine kinase (c-Abl) inhibitor with the potential to modify Parkinson's disease and its gastrointestinal complications. In April, 2021, the Company announced that it had accelerated the timeline for completion of the study based on early data that provided the opportunity to seek regulatory approval to commence dosing of PD patients in the third quarter of 2021, much earlier than previously anticipated.
Advancing chronic toxicology studies of IkT-148009 to permit long-term dosing in patients: In January, 2021 Inhibikase initiated 3- and 6-month long-term toxicology studies of IkT-148009 in mice and 3- and 9-month long-term toxicology studies of IkT-148009 in primates as required to obtain regulatory approval for chronic administration of IkT-148009 in patients. The Company has completed 3-month toxicology studies and is presently completing its histopathology analysis in preparation for submission of the data for regulatory review early in the third quarter of 2021. The Company expects to complete 6- and 9-month toxicology studies in the fourth quarter of 2021.
Initiated clinical batch manufacturing and pill formulation of IkT-001Pro. In February, 2021, Inhibikase initiated clinical batch manufacturing and final product formulation of IkT-001Pro, the Company's prodrug formulation of Imatinib, designed as a potentially safer, better tolerated treatment for Imatinib-sensitive cancers such as stable-phase Chronic Myeloid Leukemia (CML). Inhibikase expects to file an Investigational New Drug (IND) application in the third quarter of 2021, with initiation of clinical development as soon as practicable after the filing, subject to FDA acceptance of the IND.
"We are proud of the milestones we have achieved in the first quarter of 2021. The acceleration of our Phase 1 study for our lead candidate, IkT-148009 should allow us to move into evaluation of the safety, tolerability and pharmacokinetics in Parkinson's patients early in the third quarter of 2021. Concurrently, we are advancing two long term toxicology studies in animals, which will allow for chronic administration of IKT-148009 in patients following FDA review and acceptance," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "In the third quarter of 2021, we plan to file our IND application for IKT-001Pro, which holds the potential to be a safer and better tolerated treatment for cancers such as CML, and expect to initiate clinical development as soon as practicable following the submission of the IND application. We look forward to making 2021 a success as we work to advance our early stage programs forward."
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