Clinical Development of AKST4290 as a Novel Parkinson’s Therapeutic

Study Rationale:
There is clear evidence that the immune system plays an important role in the development and progression of Parkinson's disease. Novel therapies targeting the recruitment of immune cells, or inhibiting brain inflammation, could be effective in treating the disease. We have developed AKST4290, a drug that acts as a key modulator of pathologic inflammation, to assess the potential effects on multiple symptoms associated with Parkinson's disease. Pre-clinical studies in two models have shown a positive effect on motor function.

Hypothesis:
This study will test whether AKST4290 treatment results in motor function improvement in people with Parkinson's disease.

Study Design:
We will evaluate the effect of AKST4290 on motor function and activities of daily living in people with Parkinson’s disease in a Phase II, double blind, placebo-controlled clinical trial. Approximately 120 patients will be enrolled into the study to receive either placebo or AKST4290 twice daily by oral administration. Study participation will be about 15 weeks, which includes screening, a 12-week treatment period and two weeks of follow-up. The total project duration from first patient enrolled to end of study is estimated to be 15 months.

Impact on Diagnosis/Treatment of Parkinson’s Disease:
This study will help us understand whether there is any clinical benefit of treatment with AKST4290 in people with Parkinson’s disease and will help determine what assessments should be included in future clinical trials of AKST4290.

Next Steps for Development:
Upon completion of the study, AKST4290 will be evaluated for further development in Phase III clinical trials.