Little Alder BioPharmaceuticals $ALDR has racked up a slate of positive late-stage data for its Phase III study of a new CGRP migraine drug, but it will likely have trouble standing out from some of the giant players that are already out front in the race to regulators.
Dubbed PROMISE 1, investigators established a baseline average of 8.6 monthly migraines in its group of frequent episodic migraine sufferers. Alder’s quarterly-dosed 300 mg and 100 mg cut that rate by 4.3 and 3.9 days. But the placebo arm also experienced a hefty 3.2 day improvement, leaving the biotech with a statistically significant but unremarkable hit on the primary endpoint.
Investors didn’t respond well to the data, either. The shares dropped a painful 24% in pre-market trading.
The Bothell, WA-based biotech did flag some highlights, though, including a 100% response among 20% of the patients, there was a significant drop early on in the eptinezumab arm for migraines and a third achieved a 75% reduction in migraines in weeks 4 through 12. There was not, though, a significant drop in the 75% reduction group overall for the 100 mg dose.
Alder’s big promise is that its quarterly IV infusion therapy can beat or match other drugs which are more frequently dosed, making it an easier alternative preferred by patients. And it has plans for self-administration that could also position the biotech against rivals, notes Leerink’s Paul Matteis. He adds:
The “high rate of “super responders” (75% and 100% reductions)…looks very competitive compared to phase III results for other anti-CGRPs. While the approval of the IV – pending data from PROMISE2 – is mostly derisked, the results raise the question of what ALDR will do with its self-administration as the higher 300mg dose appears better than 100mg. One of the most impressive datapoints was the speed-of-onset: >50% of eptinezumab-treated patients had no migraines on day two of the study versus 37% on placebo; this was statistically significant.
But this is a field where a full lineup of major league drug developers has been cheering a series of achievements. Teva just days ago lined up a 1.5-day advantage for fremanezumab, putting it in a mix of results posted with an improvement for these drugs that tends to hover around the 2-day mark. And it has results for monthly and quarterly dosing.
Researchers are always quick to protest any trial comparisons that aren’t head-to-head, and patients populations and dosing aren’t an even match in the studies. But payers will also be expected to consider Eli Lilly’s 2-day advantage, or a Phase III outcome for Amgen and Novartis that was quite similar to Alder’s for 70 mg erenumab, the therapy that is the furthest out front. Allergan also has high hopes for its oral therapy in-licensed from Merck for $250 million upfront.
Alder also has a ways to go in completing its Phase III program.
“These positive results, consistent with previously reported eptinezumab studies, support the unique clinical profile of eptinezumab as a potential first-of-its-kind infusion therapy to prevent migraines,” says Randy Schatzman. “Enrollment is on track for PROMISE 2, our second pivotal Phase III study that focuses on chronic migraine, and we remain on track to submit our BLA with the U.S. Food and Drug Administration (FDA) in the second half of 2018.”
What’s clear is that no matter how this race ultimately pans out, migraine sufferers will soon have plenty to pick from for a new standard of care in the field. And Alder remains a key player among the developers out to make a major difference for patients.
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