- US/EU Phase III trial of A-dopamine in Parkinson’s is set for 2027
- InBrain seeks a CRO or pharma partner to support pivotal-stage research
InBrain Pharma is considering CRO or pharma partnerships for the pivotal trial of A-dopamine to treat advanced Parkinson’s disease, says CEO Véronique Foutel, PharmD. The Loos, France-based biotech is planning a Phase III trial of its lead candidate following positive results from the Phase I/II DIVE-I trial (NCT04332276). Foutel says InBrain is now considering signing a CRO or seeking a company partnership to advance the candidate into a pivotal study. The potential Phase III trial, to be named DEEP-DIVE, will enroll 170 patients across Europe and the US as InBrain will pursue marketing approval in both territories, according to Foutel. She says the company plans to initiate the trial by 2027 and projects US and EU approvals for A-dopamine in 2031 and 2032, respectively. Earlier this month, the company received a positive EMA opinion on endpoints for the Phase III study.
The trial will involve a 24-week study period with an open-label followup of over a year to assess the efficacy of A-dopamine in advanced Parkinson’s disease Foutel says InBrain is seeking a CRO by H2 2026 that can support the study in the US and Europe. Alternatively, she says InBrain is exploring partnerships with other pharma companies to take on R&D responsibilities for A-dopamine. For this, it is seeking partners with global reach, including Asia, where Parkinson’s disease is growing in prevalence.
InBrain’s treatment comprises a subdermal pump releasing dopamine hydrochloride directly to the brain. The dopamine restores lost nerve signalling between the substantia nigra and other brain regions implicated in Parkinson’s disease, addressing the impaired movement seen in Parkinson’s known as dyskinesia.
The Phase I/II DIVE-I trial enrolled 12 Parkinson’s patients with motor complications. The Phase I portion assessed the safety in all 12 patients, and no serious adverse events were reported. The Phase II part then randomized nine patients to receive oral Parkinson’s disease drugs or A-dopamine for 30 days to measure the time with dyskinesia or bradykinesia. The trial found A-dopamine allowed for a median within-patient reduction in time spent with inadequate motor control of 10.4% (p=0.027) (Moreau et al. Nature Medicine, 2025 Jan 7, 31, pp. 819–828). InBrain has signed the Évreux, France-based CDMO IDD-Xpert to upscale A-dopamine manufacture for the Phase III study, having secured EUR1.8 million ($2.1 million) to do so from the government as part of the France 2030 “First Factory” program, as per a May 12, 2025, release.
by Frankie Fattorini in London
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