No More Hold-Ups: FDA Lifts Hold on Parkinson’s Drug
Whilst there are several marketed therapeutics available to help manage the symptoms of Parkinson’s disease, there is a distinct lack of treatments which actually slow or stop the disease’s progression. Inhibikase Therapeutics hopes to change this with their protein kinase inhibitor therapeutic, IkT-148009.
Inhibikase describes the Parkinson’s drug as a “potent, selective small-molecule medication” that functions as a protein kinase inhibitor, specifically targeting c-Abl tyrosine kinase. Animal studies have revealed that by blocking the activation of Abl kinase, IkT-148009 can stop disease progression, preserve and restore lost or damaged neurons, and clear the underlying protein pathology.
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The Phase IIa clinical study for IkT-148009 in patients with untreated Parkinson’s disease began in the second quarter of 2022. The twelve-week trial was designed to evaluate the safety and tolerability of three doses of IkT-148009. It was conducted with 120 patients who had been diagnosed with Parkinson’s but had not yet progressed to the need for symptomatic treatment.
Motor and non-motor function inside and outside the brain were measured as secondary endpoints. The study also evaluated whether treatment with the drug led to a reduction or clearance of pathogenic alpha-synuclein aggregates within and outside of the central nervous system as exploratory endpoints.
However, in November last year, the FDA introduced an unexpected clinical hold on the Phase IIa trial over safety concerns. Fortunately for Inhibikase, this hold is now being lifted, as they announced in a press release in late January. They have had to agree to a protocol amendment and update the informed consent form for patients participating in the study.
More specifically, the FDA requested a measurement of visual acuity and an examination of the cornea and lens. Inhibikase stated that they had already planned to analyse the fundus, macula, and retina as part of the trial’s ocular monitoring programme.
"We believe that we now have clarity on the FDA’s expectations as we move forward in the 201 clinical trial for IkT-148009.”
Such analysis is consistent with strategies used for protein kinase inhibitors that are currently approved. The FDA has also asked for some more time to review some safety-related data in the investigator brochure which is related to the primary metabolites of IkT-148009.
The overall outlook at Inhibikase appears to be positive. In the press release, Milton Werner, CEO, stated, "We believe that we now have clarity on the FDA’s expectations as we move forward in the 201 clinical trial for IkT-148009.” He added that the company is working quickly to re-open trial sites and boost enrolment again, and they expect the trial to be fully restarted by the end of the first quarter.
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