For the second time this week, a Big Pharma–partnered Parkinson’s disease asset has failed in the clinic. This time it’s Roche reporting that a drug under development with Prothena since 2013 was unsuccessful in a Phase IIb study.
Prasinezumab was being tested in 586 people with early-stage disease in the PADOVA trial. Patients received the treatment or a placebo for 18 months while also receiving stable symptomatic drugs. Roche said that prasinezumab “showed potential clinical efficacy” on the main endpoint, which was time to confirmed motor progression, but it was not enough to reach statistical significance.
Roche pointed to “consistent positive trends” in multiple secondary and exploratory endpoints, and suggested there was evidence of better efficacy in a pre-specified subgroup of patients who received levodopa for symptoms during the study.
Jefferies analysts said the data is “promising but leaves uncertainty.” Investors did not put a lot of stock in the program, as it was deemed “a high risk/high reward option,” according to the firm.
“We believe the consistent efficacy trends from the Phase IIb study of prasinezumab merit further exploration. We will continue our close collaboration with the Parkinson’s community as we further evaluate the data to determine next steps,” said Levi Garraway, Roche’s chief medical officer and head of global product development.
Roche will continue the Phase II PASADENA and Phase IIb PADOVA open-label extension studies. Full results of the PADOVA trial will be revealed at an upcoming medical meeting.
Jefferies noted that if Roche wants to continue with the asset, a new trial will likely be needed.
On Tuesday, UCB and Novartis had shared the failure of Parkinson’s disease asset minzasolmin. Like prasinezumab, minzasolmin failed to halt progression of motor symptoms. UCB intends to terminate the extension portion of the Phase IIa trial given the absence of clinical benefit on both primary and secondary endpoints.
Get the source article here
