Inhibikase Therapeutics’ risvodetinib (IkT-148009) is safe and "effective", according to now unblinded data from the original Phase 2 trial.

[jeffreyn]

“While the dataset presented during the Movement Disorders Society congress has too few participants to conclude clinical benefit, we find these data to be cautiously encouraging as we continue to enroll patients into the ongoing 201 trial."

PNT article:

parkinsonsnewstoday.com/new...

[park_bear]

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

"In August 2023, Inhibikase presented an analysis of the primary and secondary endpoints performed on these eleven participants at the Movement Disorders Society Congress. Eight participants were on active drug (three at 50 mg, two at 100 mg and three at 200 mg) and three were given placebo. The primary endpoints were safety and tolerability and no participant experienced any clinically significant adverse events. The Company also detailed changes in the functional assessments of motor and non-motor features using a hierarchical analysis of fifteen secondary endpoints. The study evaluated non-motor function, such as activities of daily living, using the MDS-UPDRS Part 2 score and evaluated motor function using the MDS-UPDRS Part 3 score. The sum of these scores is the top functional readout in the hierarchy. Clinical improvement might be concluded if the End of Study score is lower by more than 3 to 4 points relative to the baseline score.

At the End of Study timepoint, participants administered the 200 mg dose had a combined Part 2 and Part 3 score that was lower by an average of -8.7 points. By contrast, the combined placebo score increased by an average of +1.7 points, a -10.4 point spread between actively treated versus placebo participants. Patients administered 50 or 100 mg experienced an average change of +1.7 and -1.3 points, respectively, for the combined score. An additional measure of non-motor features of disease utilized the Schwab & England Activities of Daily Life Scale (the S&E scale). The S&E scale was reduced for the 200 mg group by an average of -3.3 points relative to baseline, while the placebos had an average score increase of +3.3 points, a 6.6 point spread between the actively treated participants and the placebos; the 50 mg dose showed no effect for this measure while the 100 mg dose was on average -5.0 points lower relative to baseline."

Only three participants at the high dose were evaluated so not statistically significant, but, if this carries over to the full trial will be a very impressive result.

[LAJ12345]

Only for people who have not been treated by any other drugs for PD. I wonder if that was only for the trial or whether it will apply once it is approved too.