Inhibikase IkT-148009 Phase 2: the study ... - Cure Parkinson's

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Inhibikase IkT-148009 Phase 2: the study record on the Clinical Trials website has had a small, but significant, update.

jeffreyn profile image
9 Replies

The Estimated Study Completion Date is now January 1, 2025.

They have been recruiting for a couple of months. Enrolment activity during that time would have had some influence on the estimation of the new completion date.

According to the study record, they are seeking 90 untreated PwPs, with each PwP taking the drug (or placebo) once per day for 3 months.

classic.clinicaltrials.gov/...

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WinnieThePoo profile image
WinnieThePoo

This is one of those "good news, bad news" things, isn't it? The good news is the trial is underway and an end-date has been indicated. The bad news is that date is 1 January 2025. For phase 2. A phase 3 would take at least 2 more years plus recruitment and reporting, probably takes you to 2028 before an FDA approval. It it achieves its potential, I want it today. I am confident Milton Werner will be as efficient as is possible to get this to market (if it works!!) but it's still very frustrating waiting

jeffreyn profile image
jeffreyn in reply toWinnieThePoo

Inhibikase has recently initiated a "physician and patient awareness campaign" for the IkT-148009 Phase 2 trial. Maybe this will result in a faster recruitment pace.

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

kevowpd profile image
kevowpd

What is the hypothesis? That it slows progression? Just how much does the PD in your typical 'untreated' (IOW, early in the disease course) PWP deteriorate over 3 months?

jeffreyn profile image
jeffreyn in reply tokevowpd

"The goal of the medication is to halt and reverse the loss of function for dopamine-secreting neurons in the brain and GI tract."

inhibikase.com/patient-reso...

WinnieThePoo profile image
WinnieThePoo in reply tokevowpd

sorry for the delete - realised I had linked the wrong video

Phase 2 trial - primary outcome safety and tolerability. You don't need more than 3 months to know whether you have grown a 3rd eye

Drug also has potential symptomatic relief. Planned route to market is to obtain FDA approval as alternative symptomatic relief, and do the testing for disease modification as a phase 4 "in the field"

Although its an investment video, this clip gives a useful summary (and a reason to wonder how well Buntanetap will perform)

youtu.be/ICehRV3_Caw

kevowpd profile image
kevowpd in reply toWinnieThePoo

Fair enough. We should know if the drug is instantly fatal after three months so that's good. Same goes for symptomatic relief.

WRT in the field observation that might actually reveal something over 5 to 10 years provided you can get neurologists to provide the data.

WinnieThePoo profile image
WinnieThePoo in reply tokevowpd

They think it will take forever if they want to establish disease modification. But if it demonstrates significant clinical benefit, given its mechanism of action there would be a strong presumption for disease modification. Effectively, if it works for mice...

kevowpd profile image
kevowpd in reply toWinnieThePoo

Yes and it could be argued that the community is not exclusively thrilled-to-bits with the currently available symptom-relieving medications and consequently the approval of anther would good, DMT or not.

jeffreyn profile image
jeffreyn

For anyone new to this area of research, the following paper provides background and context.

Parkinson's Disease Modification Through Abl Kinase Inhibition: An Opportunity

movementdisorders.onlinelib...

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