Alder BioPharmaceutical’s migraine drug successfully reduced the frequency of headaches in a key clinical trial, early results that the biotech says lay the groundwork for its plans to file for FDA approval next year.
Bothell, WA-based Alder (NASDAQ: ALDR) has been studying its drug eptinezumab in patients who have episodic migraine, defined as experiencing between five and 14 migraine headaches per month. The company’s intravenously infused treatment is part of a new class of drugs that aims to prevent headaches before they start. Alder reported no side effects other than to say that its drug’s safety profile was similar to a placebo and consistent with the safety results seen in earlier trials.
But Alder’s clinical trial results did not distinguish its drug from those developed by rivals who are further along the pathway to regulatory approval, and that apparently disappointed investors. Alder’s stock price dropped more than 19 percent to $15.08 on Tuesday morning.
Eptinezumab is what’s called a calcitonin gene-related peptide inhibitor (CGRP). It works by blocking the CGRP protein, which scientists believe has a role in the transmission of pain. Alder tested its drug in 888 patients randomized to receive either eptinezumab or placebo. The main goal was measuring patients’ change in monthly migraine days, which started the trial at an average of 8.6 days. At the 300 mg dose, Alder says that this reduction in migraine days was 4.3 days; at the 100 mg dose, the reduction was 3.9 days. Patients given a placebo saw an average reduction of 3.2 migraine days.
It’s difficult to compare the clinical trial of one drug to another because trials measure different things and have different goals. But CGRP drugs from Amgen (NASDAQ: AMGN), Eli Lilly (NYSE: LLY), and Teva Pharmaceutical (NYSE: TEVA) had comparable, even slightly better reductions in episodic migraine headache frequency in their clinical trial results.
Like other CGRP drugs, the Alder drug appears to have an effect right away. After the first day of dosing the drug, Alder reported a greater than 50 percent reduction in the number of patients experiencing a migraine. Alder added that one third of patients who received its drug achieved a greater than 75 percent reduction in migraine days measured at weeks four and 12 of the trial.
Alder says it plans to file for FDA approval in the second half of next year. That puts the company behind its larger rivals in the race to bring a new migraine-preventing drug to the market. Amgen is preparing its FDA filing after reporting positive results for its CGRP inhibitor last year. In the past two months, Lilly and Teva announced plans to file for FDA approval after releasing positive data for their own CGRP drugs.
Safety could be key to the commercial success of this new drug class if companies succeed in winning FDA approval. Though a handful of drugs are already approved for migraine prevention, these include drugs developed for other conditions, such as high blood pressure and epilepsy. These treatments come with side effects such as fatigue, nausea, depression, and insomnia, according to the American Migraine Foundation.
Alder could distinguish itself from other CGRP drugs with a dosing advantage compared to its competitors. Unlike the monthly dosing of the CGRP drugs from Amgen and Lilly, Alder’s drug is administered quarterly. The prospect of less frequent needle sticks could be attractive to some patients. Teva is the only other pharma in the group that has tested its drug for quarterly dosing.
Alder is also testing eptinezumab in patients who experience chronic migraines, defined as more than 15 headaches per month. The company says enrollment in this Phase 3 clinical trial should be completed later this year. The company expects early data from the trial in the first half of 2018.