Inhibikase is inhibited no longer, nabbing another go-ahead from regulators to enter the clinic with its sole neurodegeneration asset to treat patients with a rare brain disease.
The FDA has released a clinical hold on IkT-148009 to treat patients with multiple system atrophy (MSA), green lighting future phase 2 plans, according to an announcement Wednesday. The condition slowly degrades neurons in the brain, affecting motion, balance and other basic human functions. The news comes six weeks after a similar clinical hold was lifted on trialing the asset for patients with Parkinson’s disease.
Details from the Atlanta-based company were sparse, as they’ve been regarding the MSA hold since it was first announced in November 2022. The holds on the MSA plans and Parkinson’s trial were announced together, with Inhibikase later detailing that U.S. regulators wanted more details on the dose selection in the Parkinson’s trial, information on potential vision-related side effects and additional materials on safety work conducted to date.
Evidently, Inhibikase was able to address the agency’s questions. President and CEO Milton Werner, Ph.D., thanked the agency for its “expeditious review” in a release.
The company can now proceed with its fully-fledged plans for IkT-148009, which is one of two clinical-stage assets in the company’s pipeline. It’s the only asset selected to treat a bevy of neurodegeneration conditions, including MSA, Parkinson’s, neurogenic constipation and dysphagia.
The company has a dwindling amount of money to afford its plans for potentially concurrent phase 2 trials, however, with $26.5 million on hand as of the end of September. But the company raked in a combined $10 million from private and public sales of shares in late January, two days after announcing the hold had been lifted on the Parkinson’s trial.
It’s unknown when the phase 2 trial in patients with MSA will get underway with Inhibikase saying it will first complete two ongoing preclinical studies. The future trial will assess the safety, tolerability and pharmacokinetics of IkT-148009 with secondary endpoints focused on clinical benefit. The company says patients will be dosed once daily at two different dose levels.