UK-based Mission Therapeutics has obtained clinical trial authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to assess MTX325 in a Phase I study for Parkinson’s disease.
The multi-part, adaptive study will enrol up to 160 patients across the UK, with the first participant anticipated to be dosed in the first quarter of 2024.
MTX325 is a first-in-class small molecule deubiquitylating enzyme (DUB) inhibitor that inhibits USP30. The study has gained approval based on preclinical data showing that MTX325 inhibits USP30 in mouse models and preserves dopamine-producing neurones in the brain.
The candidate is also under development for the treatment of several different conditions such as idiopathic pulmonary fibrosis, chronic kidney disease, and heart failure.
In the announcement accompanying the authorisation, Mission’s CEO Anker Lundemose said: “The MHRA’s authorisation marks a major step forward in our mission to develop MTX325 as a disease-modifying therapy for Parkinson’s disease.”
Pharma-giant Pfizer’s venture capital arm Pfizer Ventures has supported Mission since 2013 and recently raised $15m in an equity investment fundraising round in 2020. Mission’s DUB chemistry platform supports the discovery and development of DUB-targeting drugs, integrating DUB target validation, DUB-specific screening cascades and chemistry to develop the drugs.
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According to a report by GlobalData, the global Parkinson’s disease market is forecasted to reach $6.3bn in 2029, with disease-modifying therapies being the main driver.
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Mission’s other drug, MTX652, completed a Phase I trial in January for the treatment of chronic kidney disease. The randomised, placebo-controlled, double-blind study assessed the safety, tolerability, and pharmacokinetics of MTX652 in 80 kidney disease patients.
MTX652 was administered as a solution in seven single-dose cohorts between 0.25 to 200mg and four multiple-dose cohorts between 3.5mg to 100mg once a day for 14 days.
Back in 2018, AbbVie entered a collaboration with Mission to discover and advance DUB inhibitors for Parkinson’s and Alzheimer’s diseases. AbbVie gained exclusive rights to develop and commercialise DUB inhibitors against four different targets.