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.
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
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.
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?
"The goal of the medication is to halt and reverse the loss of function for dopamine-secreting neurons in the brain and GI tract."
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)
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.
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...
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.
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
Lithium for Parkinson's Book Coming in October
To speed up research and trials, we require financial support 
Clinical Trial Update 
Good Sleep Provides Benefits in the Morning 
