Details of Inhibikase Trial Suspension

[jimcaster]

Many of us have been following Inhibikase and the recent suspension of trials by the FDA. Inhibikase just issued a press release regarding the concerns expressed by the FDA.

"The FDA raised several points, summarized below, in their explanation of the basis for the clinical hold:

Further evaluation of the existing safety and pharmacokinetic ("PK") data and justification supporting the use of the 200 mg dose used in the Phase 2a '201' clinical trial.

A better understanding of how the clinical trial will monitor the potential for detecting adverse events that could affect vision in trial participants and whether those adverse events are reversible.

Need for material additions to the disclosures made to investigators and patients related to the clinical and safety measures completed to date, including the potential risks to vision in trial participants."

prnewswire.com/news-release...

[Hidden]

inhibikase.com/news/press-r...

[jimcaster in reply to Hidden]

That's the same press release which I attached to my post. 🙂

[Hidden in reply to jimcaster]

yes it is

[Boscoejean]

Here is what I do not understand. I had read that they had had no side effects in the first trial so I am wondering why there is concern about side effects with regard to vision.

[WinnieThePoo]

Where did you read that? The phase 1 is still active and due to complete December 2022

[jimcaster in reply to WinnieThePoo]

She may be thinking of this quote in the press release from Inhibikase right after the FDA stopped their trial:"We have not seen any serious adverse events in the ongoing 201 trial and we remain committed to our mission to improve the lives of patients suffering from devastating neurodegenerative diseases," commented Milton H. Werner, Ph.D., President and Chief Executive Officer. "Given the safety, tolerability and pharmacokinetics data observed in clinical trials with IkT-148009 to date, we are actively working with the FDA to understand the agency's concerns and to resolve them as soon as possible."

[jeffreyn]

See also this recent PNT article, which includes a link to a paper dealing with ocular issues.

parkinsonsnewstoday.com/new...

ncbi.nlm.nih.gov/pmc/articl...

[Hidden]

healthunlocked.com/cure-par...