Servier Licenses LRRK2 Inhibitor, Phase 1 Trial to Start by Year’s End

Trial will test the safety of potential Parkinson's therapy in healthy volunteers

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by Andrea Lobo |

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Servier is set to launch a Phase 1 clinical trial in healthy volunteers to investigate an LRRK2 inhibitor, developed in collaboration with Oncodesign, as a treatment for Parkinson’s disease.

The trial, to start before the end of the year, follows the clearance of the Phase 1 clinical trial program by an ethics committee and the French National Agency for the Safety of Medicines (ANSM).

“[LRRK2] has proven to be very difficult to target with inhibitors but has the potential to slow the progression of Parkinson’s disease,” Jan Hoflack, PhD, chief scientific officer and managing director of Oncodesign, said in a company press release. “This would be a major progress for patients suffering from this disease, for which only symptomatic treatments currently exist.”

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Servier has exercised its exclusive worldwide license option for the selected inhibitor, developed as part of a partnership with Oncodesign, gaining full development and commercialization rights to the compound.

The company will pay €7 million (about $6.8 million) to Oncodesign Precision Medicine, a subsidiary of Oncodesign, for the licensing option. Under the terms of the agreement, Servier may pay up to €320 million in total (nearly $312 million), pending certain regulatory and commercial milestones, and potential royalties on future sales.

“The approval of the [clinical trial application] dossier by the ANSM and the [ethics commitee], and the exercise of the license option by Servier, precede the first evaluation in humans of our key LRRK2 inhibitor drug candidate,” Hoflack said.

Mutations in the LRRK2 gene ­are one of the most common causes of sporadic and familial types of Parkinson’s. These mutations increase the activity of a protein kinase with the same name, LRRK2, which is believed to result in the abnormal activation of certain immune cells in the brain and cause nerve cell damage.

Blocking LRRK2 could therefore have therapeutic potential in Parkinson’s disease. Phase 1 clinical trials with other LRRK2 inhibitors have shown encouraging results.

“The progress of the research and development program for this drug candidate in Parkinson’s disease is the result of the combined expertise of Servier and its partner Oncodesign,” said Ross Jeggo, PhD, global head of neuroscience and immuno-inflammation therapeutic area at Servier.

Servier and Oncodesign entered a research and development collaboration in March 2019 to develop new LRRK2 kinase inhibitors for Parkinson’s disease. The partnership drew upon Servier’s expertise in neurodegenerative diseases and Oncodesign’s proprietary technology platform, Nanocyclix, for designing, making, and optimizing small molecule kinase inhibitors.

The companies then announced the selection of their lead candidate LRRK2 kinase inhibitor in July 2021, noting plans to start regulatory preclinical safety studies that could support the initiation of clinical trials.

“There is still a long way to go before the candidate becomes a drug, but this step was crucial and announces further successes for the benefit of patients,” said Philippe Genne, PhD, chairman, CEO, and founder of Oncodesign and Oncodesign Precision Medicine.