Lilly, Biogen Alzheimer’s Drugs Demonstrate Encouraging Results

Eli Lilly and Biogen last week reported back-to-back positive clinical trial results for their investigational Alzheimer’s disease drugs, heating up the race for an effective cure.

Patients with mild Alzheimer’s disease who took Lilly’s solanezumab early preserved more cognitive and functional ability than those who took the drug later on. The treatment effect remained statistically significant at 108 weeks, or 28 weeks after the start of a delayed-start period, Lilly says.

The results are from a Phase 3 extension study that looked at continued benefit when patients given solanezumab during an initial 18-month study received the drug for another two years.

If approved by the FDA, SunTrust Robinson Humphrey analyst John Boris predicts Lilly’s Alzheimer’s candidate could reap more than $10 billion in annual sales.

Meanwhile, Biogen’s aducanumab reduced beta amyloid plaque in the brain in a Phase1b placebo-controlled study, the company says. Two of three dosages evaluated — 3 mg and 10 mg — also showed statistically significant slowing of cognitive decline, but the 6 mg dose did not. The drugmaker is now screening patients for Phase 3 studies.

Mark Schoenebaum, an analyst with Evercore ISI, says the aducanumab results continue to indicate Phase 3 success. “The benefit still looks robust to us (with all the caveats of reading too much into small trials) and better than LLY’s sola (acknowledging that no head-to-head trials have been performed and trial designs were different),” he writes in a research note.

Last month, the FDA called for more collaboration and research to develop drugs to treat diseases including Alzheimer’s, which has no effective treatment. — Jonathon Shacat