Roche's Another Alzheimer's Hopeful Flops In Phase 3 Program, Second Trial Setback Within Months

  • MorphoSys AG's MOR partner Roche Holdings AG RHHBY announced results from the GRADUATE I and II studies evaluating gantenerumab in mild cognitive impairment (MCI) due to Alzheimer's and mild Alzheimer's dementia.
  • The studies did not meet their primary endpoint of slowing clinical decline. 
  • Gantenerumab was well tolerated, including the subcutaneous administration.
  • 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.
  • Gantenerumab showed a slowing of clinical decline in GRADUATE I and GRADUATE II of -0.31 and -0.19, respectively, from baseline. However, neither was statistically significant. 
  • This represents a relative reduction in the clinical decline of 8% in GRADUATE I and 6% in GRADUATE II compared with placebo. 
  • The GRADUATE Phase 3 program evaluated gantenerumab over 27 months in over 1,900 participants.
  • In July, Roche's other Alzheimer's medicine, crenezumab did not slow or prevent cognitive decline in people with a specific genetic mutation that causes early-onset disease.
  • In September 2000, MorphoSys collaborated with Roche.
  • MorphoSys is entitled to receive tiered royalties, ranging from 5.5% to 7.0%, on net product sales and potential success-based regulatory milestone payments related to gantenerumab. 
  • MorphoSys will retain 40% of future royalties on gantenerumab and pass 60% to Royalty Pharma. 
  • Price Action: MOR shares are down 29.30% at $3.86 during the premarket session on the last check Monday.
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