Immunis plans Phase 1 trial of treatment for Parkinson’s dyskinesia
Company says preclinical studies show KORA eases levodopa-induced dyskinesia
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- Parkinson's patients often develop dyskinesia from long-term levodopa use.
- Immunis plans a Phase 1 trial for KORA, a potential treatment.
- Preclinical studies show KORA reduced dyskinesia in rats.
Immunis said it entered into an exclusive deal with Toray for the rights to develop and commercialize a potential treatment for dyskinesia, the involuntary movements associated with long-term use of levodopa in people with Parkinson’s disease, and has submitted an application to the U.S. Food and Drug Administration (FDA) to begin a Phase 1 clinical trial.
The agreement gives Immunis exclusive rights to the treatment, KORA (nalfurafine, formerly TRK-820), for levodopa-induced dyskinesia in the U.S., Canada, the European Union, and the European Free Trade Association. Financial terms were not disclosed.
“Immunis is thrilled to expand our research pipeline to include a common and serious complication affecting Parkinson’s disease patients,” Mark Cabato, chief business officer at Immunis, said in a company press release. “Our collaboration with Toray reflects our continued commitment to maximizing healthspan and minimizing disease through the advancement of transformative medicine.”
Levodopa effective, but side effects problematic
Parkinson’s is caused by progressive loss of dopaminergic neurons, the nerve cells that produce dopamine, a signaling molecule neurons use to communicate. Levodopa (L-DOPA) is the most effective treatment for easing Parkinson’s motor symptoms. It contains a precursor molecule that the body can use to produce dopamine, helping to restore its levels.
However, long-term use of levodopa can cause side effects, including dyskinesia. It may also alter the expression of kappa opioid receptors in the striatum and substantia nigra, two brain regions involved in motor control that are affected by Parkinson’s.
IMM02-KORA, or KORA, is a selective agonist, a molecule designed to bind and activate kappa opioid receptors. In a preclinical study, the treatment effectively reduced L-DOPA-induced dyskinesia symptoms in a rat model of Parkinson’s disease.
It appeared to inhibit excessive dopamine release in animals with dyskinesia, without affecting levodopa’s therapeutic effects.
The treatment is approved in Japan, under the brand name Remitch, for the treatment of itching in people with certain kidney conditions. Studies in healthy male volunteers, in which multiple doses of the treatment were tested, demonstrated that the most frequent adverse events included mild sleep disorders and somnolence, and laboratory changes in the levels of certain hormones. Researchers don’t know whether KORA causes similar effects in people with Parkinson’s.
