Inhibikase Therapeutics is eying pulmonary arterial hypertension (PAH) as a potential indication for its imatinib alternative IkT-001Pro.

In an 18 April letter to shareholders, the pharma company’s CEO Milton Werner said, “We believe that there is an opportunity worth exploring” for the disease that is characterised by high blood pressure in the lungs.  

IkT-001Pro is a prodrug formulation of imatinib mesylate. Inhibikase is developing its candidate as an improvement over Novartis’ Gleevec. Gleevec, a kinase inhibitor, is indicated to treat certain leukaemia’s, myelodysplastic syndromes, and other cancers, according to its US Food and Drug Administration (FDA) drug label. The drug was first approved in 2001.

Werner points to positive disease-modifying evidence for Gleevec in PAH patients from more than a decade ago, adding that only an unfavourable safety and tolerability profile meant it was not approved.

Inhibikase believes the better tolerability profile of 001Pro over Gleevec coupled with changes in standard-of-care and anti-coagulant use exclusion means PAH could represent a future clinical avenue for its asset. In February this year, Inhibikase had a pre-new drug application (NDA) meeting with the FDA for IkT-001Pro, which  Werner said “constructive”. The company is pursuing eleven indications that have all been previously approved for Gleevec.

MSD’s Winrevair (sotatercept) became the first disease-modifying treatment for PAH approved in the US last month. The annual cost of the drug will be $238,000.

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The PAH market is expected to reach $7.5bn across the seven major markets by 2029, according to analysis conducted by GlobalData in 2022.

GlobalData is the parent company of Clinical Trials Arena.

Pipeline update

In the letter to shareholders, Inhibikase also provided updates on clinical trial milestones. The pharma company has reached 75% enrollment in its Phase II trial (NCT05424276) investigating risvodetinib (IkT-148009) in the treatment of Parkinson’s disease. Enrollment is expected to be completed by mid-June.

Inhibikase is planning an end-of-Phase II meeting with the FDA by the end of this year for the drug, and is developing Phase III protocols for the extension study.  

Inhibikase is also evaluating risvodetinib in the treatment of multiple system atrophy. The FDA lifted a clinical hold on the drug in March last year. Werner said the company is continuing to evaluate potential pathways to initiate a Phase II/III trial in this indication.

Risvodetinib had gained FDA orphan drug designation for multiple system atrophy in October 2023.