Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), announced on 4/24/18 that new twelve-month data from its PROMISE 1 Phase 3 clinical trial in episodic migraine patients. The data demonstrated that patients experienced even further reductions in migraine following the third and fourth quarterly infusions at both dose levels (100mg and 300mg) of eptinezumab, Alder’s lead investigational product candidate for migraine prevention targeting calcitonin gene-related peptide (CGRP).

PROMISE 1 Results Following Third and Fourth Eptinezumab Infusions
Key points:
Responder rates for month six through month twelve:

• 70.7 percent of patients achieved on average a 50 percent reduction or greater of monthly migraine days from baseline compared to 58.7 percent for placebo. This represents an 8.9% improvement from the reductions experienced during the first two quarterly doses of eptinezumab;
• 51.5 percent of patients achieved on average a 75 percent reduction or greater of monthly migraine days from baseline compared to 38.7 percent for placebo. This represents a 12.8% improvement from the reductions experienced during the first two quarterly doses of eptinezumab

“I am very excited to see the encouraging results in migraine prevention shown in the PROMISE 1 long-term data,” said Stephen D. Silberstein, M.D., Professor of Neurology and Director of the Jefferson Headache Center, Thomas Jefferson University. “I see a significant need for my patients for a treatment that provides rapid, effective, well-tolerated and long-term results and I’m looking forward to the FDA’s review of these data.”

The observed safety profile for PROMISE 1, to date, is consistent with previously reported eptinezumab studies. The most commonly reported adverse events occurring at an incidence of 5 percent or greater across all eptinezumab treatment groups were upper respiratory infection (10.5 percent), nasopharyngitis (common cold) (6.8 percent) and sinusitis (3.6 percent).

Eptinezumab is an investigational monoclonal antibody discovered and developed by Alder BioPharmaceuticals for migraine prevention. Eptinezumab is the only potent and selective anti-CGRP mAb administered by quarterly infusion for migraine prevention, delivering 100% bioavailability to immediately inhibit CGRP. Eptinezumab has been studied in several global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention.

Several other companies are developing drugs with similar mechanisms of action:

• Amgen and Novartis -  erenumab
• Teva -  fremanezumab
• Eli Lilly - galcanezumab