Inhibikase, FDA find common ground to lift hold on Parkinson's drug

After a brief 2.5-month hold, Inhibikase Therapeutics’ Parkinson’s disease therapy is heading back to the clinic.

The FDA unexpectedly placed a clinical hold on the midstage therapy IkT-148009 in November 2022, sending Inhibikase’s shares tumbling. The phase 2a trial is now set to get back on track, according to a Wednesday press release. CEO Milton Werner, Ph.D., said in the release that the company is now working quickly to re-open trial sites and get enrollment going, with the restart activities expected to be completed by the end of the first quarter.

Inhibikase agreed to a protocol amendment and updated the informed consent form for patients in the study. Specifically, the FDA asked for a measurement of visual acuity and examination of the cornea and lens. Inhibikase had already planned to analyze the retina, macula and fundus as part of the ocular monitoring program in the trial. These programs are consistent with strategies used for protein kinase inhibitors that are already approved. The company says that it has not seen any ocular pathology issues with IkT-148009 to date.

The agency also asked for more time to review some safety-related data in the investigator brochure that had to do with the primary metabolites of IkT-148009.

“We believe that we now have clarity on the FDA’s expectations as we move forward in the 201 clinical trial for IkT-148009,” Werner stated.

The hold came as Inhibikase was applying to start a second trial for the therapy in multiple system atrophy (MSA). Instead of giving the okay, the FDA slapped a hold on both studies. With the go-ahead from the FDA in Parkinson’s disease, Inhibikase intends to ask for a lifting of the hold on the other indication as well.

Inhibikase's shares rose almost 10% to $1 Wednesday morning, compared to a prior close of 91 cents.