The study results announced today for the Alzheimer's drug Gantenerumab from MorphoSys's license partner Roche caused a drop in the MorphoSys share price. On Tradegate, the shares of the Planegg-based biotech company lost 18 percent compared to the Xetra close to just over 17 euros. The phase 3 trials had not achieved their goal of slowing the clinical course of the disease.
The primary endpoint of phase 3 clinical trials evaluating the monoclonal antibody gantenerumab in early Alzheimer's disease (AD) was missed. The level of beta-amyloid removal, the protein that builds up to make plaques in the brains of people with Alzheimer's disease, was lower than expected.
The GRADUATE Phase 3 program evaluated the safety and efficacy of gantenerumab in people with mild cognitive impairment (MCI) due to Alzheimer’s and mild Alzheimer’s dementia over 27 months. 1,965 study participants across 30 countries were randomized 1:1 to receive gantenerumab or placebo by subcutaneous injection titrated to reach a target dose of 510 mg administered every two weeks. Gantenerumab is a fully-human monoclonal IgG1 antibody that was discovered in collaboration with Roche.
At the beginning of October, Dr. Jean-Paul Kress, Chief Executive Officer of MorphoSys, was still optimistic about the current outlook at a press conference.
Now he expressed disappointed: “We are disappointed by these results as there are millions of people impacted every day by Alzheimer's disease. We are grateful to Roche, our long-standing partner, for their work on the GRADUATE program and their commitment to the Alzheimer’s community.”
Already in September 2000, MorphoSys entered into a worldwide collaboration agreement with Roche. Under this agreement, Roche is fully responsible for the clinical development and potential commercialization of gantenerumab. MorphoSys would then be eligible to receive tiered royalties as well as potential performance-based regulatory milestone payments. However, 60% of the royalties would be received by Royalty Pharma. MorphoSys's multi-billion dollar strategic partnership with Royalty Pharma, announced in mid-2021, should drive the company's expansion.
The topline findings of the GRADUATE I and II studies will be presented at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) Conference on Wednesday, November 30, 2022 at 16:15 PT.