Bayer touts positive start for Parkinson's gene therapy
04 Jan 2024
Phase 1Clinical ResultGene TherapyAcquisitionCell Therapy
Bayer on Thursday announced encouraging results from a Phase Ib trial of its AB-1005 gene therapy in Parkinson's disease patients. The study met its primary objective, which was to evaluate the safety of delivering AB-1005 directly to the brain.
Bayer acquired the AAV serotype 2 vector containing the GDNF transgene via its $4-billion takeover of Asklepios BioPharmaceutical (AskBio) in 2020. According to AskBio, AB-1005 was well tolerated in the study and there were no serious adverse events attributed to the treatment in any of the 11 patients at 18 months. Participants were about evenly split between those with mild or moderate disease.
The assessment also demonstrated feasibility of administering AB-1005 to the putamen via one-time bilateral, convection-enhanced, neurosurgical delivery. The delivery of AB-1105 resulted in putamen coverage of about 63%, surpassing the target of >50% coverage. Ongoing clinical follow-up will continue for up to 5 years post-administration.
Gearing up for Phase II
"We are encouraged by these early data," commented Krystof Bankiewicz, scientific chair for Parkinson's and MSA at AskBio, adding "these first findings will inform our work in this space." With Thursday's announcement, Bayer notches another win in Parkinson's, having reported positive early results last June for its bemdaneprocel cell therapy that prompted a move into Phase II. It picked up that asset through a deal for BlueRock Therapeutics back in 2019.
AskBio said it plans to unveil 18-month study data for AB-1005, including secondary endpoints, at a scientific meeting in the second quarter. Meanwhile, preparations are underway for a Phase II trial set to screen patients in the first half of 2024, with the trial design having received "harmonised feedback" from US and European health authorities, the company said.
In 2022, AskBio unveiled early data for another gene therapy product, AB-1002, this time tested in a small group of patients with congestive heart failure. They showed clinically meaningful improvements with no safety concerns after a year's follow-up. AB-1002 targets phosphatase inhibitor-1 and is delivered via a single antegrade coronary artery infusion.
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