Sun Pharma Advanced Research Company (SPARC) is conducting a Phase ll clinical trial to evaluate the safety and effectiveness of its experimental c-Abl inhibitor K0706 in people with early Parkinson’s disease (PD).

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 PD.

Results of SPARC’s pivotal Phase l study, which evaluated the safety and tolerability of ascending doses of K0706 in PD patients, showed that the therapy was well-tolerated and allowed the selection of two K0706 doses likely to produce therapeutic effects.
This 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.

The study’s primary goal is to assess changes in patients’ motor functions. Researchers will also assess K0706’s impact on the health of dopamine-producing neurons in PD patients through specialised (DaT SPECT) brain imaging.

DaT SPECT is a highly sensitive imaging tool capable of distinguishing people with Parkinson’s from unaffected people even in early stages of the disease. DaT SPECT images will be able to help determine the density of healthy dopamine-producing neurons in the triallist's brain.

Results of this proof of concept trial, if found to be positive, are expected to support the advancement of K0706 into Phase lll clinical studies in Parkinson’s patients.

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Parkinson's News Today - article September 12th 2019