Biohaven has released a set of positive Phase III data for their fast-acting migraine drug, which closely parallel a rival at Allergan and trail well behind Eli Lilly’s lasmiditan. And the biotech will now join the scramble underway for an approval in a field that’s about to be severely disrupted.
Investors didn’t like the numbers early Monday morning, sending shares $BHVN down 40%. That clearly wasn’t the way Biohaven was betting. The biotech paid Bristol-Myers Squibb $50 million just a couple of weeks ago to restructure their licensing deal, cutting the royalty stream to the single digits. But in the hours up to the close, the stock — backed by some heavyweight market players — went on a roller coaster ride in the red, ending the day down 7%.
Allergan — which will have another Phase III trial to report on — saw its shares rise a bit, while Lilly stock jumped close to 2%.
The co-primary endpoints for Biohaven’s oral rimegepant (BHV-3000) was pain freedom and freedom from most bothersome symptom 2 hours after taking the pill in two pivotal studies.
Their pain freedom rate was 19.2% and 19.6% for the drug, versus 14.2% and 12% for the placebo arm. Freedom from MBS was 37.6% and 36.6% versus 25.2% and 27.7% in the sugar pill group.
That evidently may have been statistically significant, but it wasn’t a big enough spread to convince skeptics wondering about the drug’s clinical significance in a competitive field.
Compare rimegepant to Allergan’s oral CGRP ubrogepant, where the first Phase III reported out freedom for pain at 2 hours for 19.2% and 21.2% for two different doses and 11.8% in the placebo arm; 38.6% and 37.7% on MBS and 27.8% in the placebo arm.
Eli Lilly’s lasmiditan — which works by hitting 5-HT1F receptors — did even better, despite being dogged by high placebo rates. Lilly $LLY, which paid $960 million to buy CoLucid and lasmiditan, also has a CGRP drug that has performed in line with the rest of the injectables.
Two hours after taking lasmiditan or a placebo, here were the the latest Phase III responses on freedom from pain by dosage: 28.6% for 50 mg (p=0.003); 31.4% for 100 mg (p<0.001); 38.8% for 200 mg (p<0.001) and 21.3% for placebo. Investigators also nailed an endpoint on freeing patients of their most bothersome symptom, whether that was nausea, sensitivity to sound or sensitivity to light. The data: 40% for 50 mg (p=0.009); 44.2% for 100 mg (p<0.001); 48.7% for 200 mg (p<0.001) and 33.5% for placebo.
Back-to-back Phase IIIs, however, won’t translate into a quick FDA filing. Biohaven noted in a release that it won’t be ready to file until 2019, keeping up with Allergan on that score.
The rivals here are betting that they can take market share for treating migraines as heavyweights compete over injectable CGRP drugs headed to regulators for the prevention of acute migraine. Amgen and Novartis lead the way on that front, with a drug under review. Teva, and Alder are angling for a followup position.
The one common characteristic of these drugs is that they all perform in remarkably similar ways, leaving oral delivery and price as two features that these two new therapies can compete on. Allergan has also had to explain some cases of liver tox in its first Phase III — a concern for the class — while Biohaven says it saw nothing to alarm investigators in its Phase III studies.
Biohaven CEO Vlad Coric had this to say:
By combining positive efficacy results and a favorable safety profile with ease of oral dosing, we believe that rimegepant will represent a significant improvement over existing treatment options.
Biohaven shares also took a beating last fall when their Phase II/III study of trigriluzole demonstrated not only that it didn’t work better than a placebo in treating spinocerebellar ataxia, but patients in the study also reported in larger numbers that the placebo helped them more than the drug.
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