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From time to time, we may use our website and our LinkedIn account at https://www.linkedin.com/company/inhibikase-therapeutics/ to distribute material information about us and for complying with our disclosure obligations under Regulation FD.
Company Overview We are a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases, namely, Pulmonary Arterial Hypertension ( PAH ), in which aberrant signaling through type III receptor tyrosine kinases, including platelet derived growth factor receptors and a stem cell factor receptor, known as c-Kit , has been implicated.
Our lead product candidate is IKT-001, a prodrug of imatinib mesylate ( imatinib ), for PAH which is an orphan indication.
Imatinib was first approved in the United States in 2001 for various cancers and blood disorders and, following more than 20 years of clinical use, has a well-characterized safety profile with the first reported use of imatinib in PAH occurring in 2005.
PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans.
We have completed a non-human primate safety study and a bioequivalence clinical study in healthy volunteers to determine the doses of IKT-001 that are equivalent to imatinib.
Our Phase 3 clinical study, named IMPROVE-PAH ( I KT-001 for M easuring P ulmonary Vascular R esistance and O utcome V ariables in a Phase 3 E valuation of PAH ), has been initiated with the activation of a small number of sites and the recent commencement of patient pre-screening activities at those sites.
IKT-001 IKT-001 emerged from our medicinal chemistry program that targeted improving drugs that inhibit Abelson Tyrosine Kinase and type III receptor tyrosine kinases.
IKT-001, a novel oral prodrug of imatinib, was designed to improve areas of the molecule that might play a role in the gastrointestinal ( GI ) side effects commonly observed with imatinib.
More specifically, when compared directly with imatinib in vitro , IKT-001 has significantly less inhibitory activity at target tyrosine kinases including c-Kit which has been implicated in the GI side effects of imatinib.
REMOVED
From time to time, we may use our website, our X (formerly known as Twitter) account at https://twitter.com/inhibikase and our LinkedIn account at https://www.linkedin.com/company/inhibikase-therapeutics/ to distribute material information about us and for complying with our disclosure obligations under Regulation FD.
Company Overview We are a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary and other diseases including those that arise from aberrant signaling through the Abelson Tyrosine Kinase, and type III receptor tyrosine kinases including platelet derived growth factor receptors and proto-oncogene c-KIT ("c-KIT").
The Company s multi-therapeutic pipeline includes IKT-001, a prodrug of imatinib mesylate, for Pulmonary Arterial Hypertension (PAH).
IKT-001 was designed to improve the oral absorption, reduce GI side effects and enhance the safety of active pharmaceutical ingredients.
IKT-001 is a prodrug of imatinib, an FDA approved treatment for certain blood and stomach cancers.
We plan to seek approval from the FDA for IKT-001 in PAH as an orphan indication.
We have completed non-human primate safety studies and a bioequivalence clinical trial in healthy volunteers to determine the doses of IKT-001 that are equivalent to imatinib mesylate and the results are being utilized to set the doses in a Phase 2b trial to determine if IKT-001 could be a disease-modifying treatment for PAH.
We have also developed risvodetinib (also known as IkT-148009), a selective inhibitor of the non-receptor Abelson Tyrosine Kinases that targets the treatment of Parkinson s disease inside and outside the brain.
In 2023, we initiated the Phase 2 201 trial ( 201 Trial ) for risvodetinib (IkT-148009) as a treatment for Parkinson s disease and completed that trial on October 6, 2024.
In January 2025, we reported results from the 201 Trial and decided to pause further development of risvodetinib as we focus our resources on advancing lead program IKT-001 in PAH.