Phase 2 clinical trial to explore experimental K0706 in early Parkinson’s
Sun Pharma Advanced Research Company (SPARC) is conducting a phase 2 clinical trial to evaluate the safety and effectiveness of its experimental c-Abl inhibitor K0706 in people with early Parkinson’s disease.
The trial, which is recruiting approximately 500 participants, will randomly assign participants to receive one of two doses of K0706 or a placebo, taken daily for nine months.
K0706, also known as SCC–138, works as a suppressor of an enzyme called Abl tyrosine kinase, whose activity has been linked to several processes associated with Parkinson’s development, such as inflammation stress and alpha-synuclein-induced neurodegeneration. Earlier studies have shown that K0706 prevents the loss of dopamine-producing neurons in the brain and has shown to lessen behavioral symptoms in animal models of Parkinson’s.
Results of SPARC’s pivotal phase 1 study, which evaluated the safety and tolerability of ascending doses of K0706 in people with Parkinson’s, showed that the treatment was well-tolerated and allowed the selection of two K0706 doses likely to produce therapeutic effects. Now the double-blind, placebo-controlled PROSEEK Phase ll study , will evaluate the safety and effectiveness of the two selected K0706 doses in people with early Parkinson’s who are not receiving any dopaminergic therapy.
Results of this proof of concept trial, if found to be positive, are expected to support the advancement of K0706 into phase 3 clinical studies in Parkinson’s patients.