Drugs for Alzheimer Disease: The maximum success rate is only 50%?
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Drugs for Alzheimer Disease: The maximum success rate is only 50%? Eli Lilly, Roche and Biogen to disclose key data on their AD drugs.
Although the controversy over the accelerated approval of Biogen’s Aduhelm is still high, this has not hindered the enthusiasm for the development of other Alzheimer’s disease (AD) drugs.
Three additional amyloid-targeted drugs for Alzheimer’s disease from Roche , Eli Lilly and Biogen will soon release new pivotal data.
This week, analysts at Stifel Biotechnology Equity Research predicted in a new investor note that Eli Lilly’s donanemab is the most likely approval. But the three companies still need to answer some questions before being officially approved.
In the case of Eli Lilly’s donanemab, the company recently delayed its FDA filing until the end of this year, and new data won’t be released until mid-2023.
Stifel explained that in earlier trials, donanemab “reduced plaque significantly and rapidly,” with a success rate of about 50 percent. But it did not reach the “proposed threshold for optimal clinical use (<20CL) , and compared to other monoclonal antibodies (mAbs) , it appeared to take around 12 months to stabilize”.
“The p-value of 0.04 is due to underpowered, and this effect should be more pronounced in a larger Phase III trial,” Stifel analysts wrote in a donanemab report.
Biogen, on the other hand, is awaiting a final decision on the National Coverage Determination (NCD) for Aduhelm , which is partnering with Eisai on a second trial of the Alzheimer’s drug lecanemab, which is expected to receive 18 in the third quarter of this year. month’s data.
Stifel predicted a success rate of about 30% for lecanemab, noting: “While the trial was successful in Phase II, it was difficult to (1) demonstrate that an imbalance in APOE4 did not help, at least for a period of time (2) that lecanemab missed III Phase II endpoint (CDR-SB) , which may be a more challenging measure than many believe. On the surface, the Phase II data for lecanemab are good, completing 2 out of 3 clinical scales. Although It’s a big investment, but the APOE4 imbalance is severe, and there are data showing that these patients have significantly greater plaque burdens and faster progression.”
While Stifel believes the drug is active, the Phase II data are “mixed and probably more problematic, and the Phase III endpoint, CDR-SB, is a high bar (even donanemab didn’t meet that metric) .”
Roche’s gantenerumab had a success rate of about 20-25% in data released at the end of this year, “or at least a notch lower than lecanemab as a matter of common sense,” the analysts wrote.
“While gantenerumab does have a large plaque effect at high doses, there is essentially no pre-clinical evidence for risk reduction, and we believe it has the greatest risk of the three drugs,” they added.
“The PET data is the most optimistic and looks solid, but it is based on a small and diverse OLE (30 patients over 3 years) . Also, the kinetics of subcutaneous administration seem to be slower than intravenous administration. At the same time, Roche is running a longer trial (27 months) , and a 9-month titration that may offset this. Finally, we also wondered whether gantenerumab might have some affinity for monomers that could be set aside Metrology, reducing the rate/magnitude of plaque/oligomer reduction.”
But analysts also pointed out that they believe the interpretation/meaning of the “class” of amyloid-targeting drugs depends largely on whether at least 2 or 3 drugs are actually effective.
Reference:
https://endpts.com/a-trio-of-amyloid-targeted-alzheimers-drugs-will-soon-see-key-results-but-an-analyst-predicts-only-50-50- odds-for-one/
Drugs for Alzheimer Disease: The maximum success rate is only 50%?
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