Parkinson’s disease clinical trials : Cerevel Therapeutics, a US biopharma company, has initiated a phase 3 clinical trial program for evaluating tavapadon in Parkinson’s disease patients, as per the latest clinical trial news.
Tavapadon is being developed as an orally-bioavailable, selective partial agonist of the dopamine D1 and D5 receptors, and is being assessed for the daily once symptomatic treatment of Parkinson’s disease.
The biopharma company based in Boston is set to undertake three 27-week Parkinson’s disease clinical trials for assessing the efficacy, safety, and tolerability of fixed doses (TEMPO-1) and flexible doses (TEMPO-2, TEMPO-3) of tavapadon. The investigational drug is being studied as a monotherapy in patients with early-stage Parkinson’s disease or as adjunctive therapy to levodopa in late-stage Parkinson’s disease patients who are facing motor fluctuations.
Cerevel Therapeutics said that a fourth 58-week, open-label, safety extension trial will also be undertaken as part of the phase 3 clinical program in Parkinson’s disease.
Raymond Sanchez – chief medical officer of Cerevel Therapeutics said: “Parkinson’s disease affects approximately 10 million people worldwide, and there remains an important need for better and more effective therapies across the spectrum of this debilitating disease.
“We believe tavapadon has the potential to improve outcomes for patients with both early-stage and late-stage Parkinson’s. It is our expectation that the innovative design of each of these Phase 3 trials will allow us to demonstrate tavapadon’s ability to improve patients’ motor symptoms and functioning. We anticipate data from these trials to be available beginning in the second half of 2022.”
The three phase 3 clinical trials in Parkinson’s disease will take in patients aged between 40 and 80 years whose condition is at an early-stage (TEMPO-1, TEMPO-2) or patients having late-stage disease and are having motor fluctuations on levodopa treatment (TEMPO-3).
Nearly 1,200 patients will be enrolled across all the three Parkinson’s disease clinical trials.
The primary endpoint of the TEMPO-1 and TEMPO-2 clinical trials is the variation from baseline in the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II and Part III combined score. On the other hand, the primary endpoint of the TEMPO-3 clinical trial is the variation from baseline in total daily “on” time without troublesome dyskinesias.
In all the three 27-week Parkinson’s disease clinical trials, the enrolled patients will be randomly grouped to receive tavapadon or placebo.
In the TEMPO-1 trial, the Parkinson’s disease patients will be titrated up to a fixed dose of either 5 mg once daily (QD) or 15 mg QD of tavapadon. In the TEMPO-2 and TEMPO-3 clinical trials, the participating patients will be titrated upward to a dose of between 5 mg and 15 mg QD in a flexible dosing paradigm.
The TEMPO-1 and TEMPO-2 Parkinson’s disease trials have already started screening of patients while screening for the TEMPO-3 clinical trial will begin later this year.