Towards the end of August, we published this piece detailing two major potential upside catalysts to keep an eye on early September. One of the companies we profiled was CoLucid Pharmaceuticals Inc (NASDAQ:CLCD), a small cap biotech based out of Massachusetts.
About a week after we first highlighted CoLucid, we included the company as part of our Movers and Shakers series, based on a double digit session span gain early last week. We suggested that the upside run may be in anticipation of positive data from the catalyst in question, and might be indicative of a near term run up.
The company is about to close out the US session on Tuesday, post Labor day, and it is up just shy of 130% at time of writing. The gains come on the back of – you guessed it – positive trial data from the company’s lead migraine trial, SAMURAI, and the data is indicative of a succesfull campaign going forward into the next phase – registration.
With this in mind, and ahead of a potential commercialization bid from CoLucid Pharmaceuticals Inc (NASDAQ:CLCD), let’s revisit the drug in the light of the new data, and speculate as to its chances of approval on the back of the results.
The drug in question is called Lasmiditan, and as mentioned, it’s a migraine target indication. It’s pretty unique in its MOA, at least it is in this space. Migraines are caused by excessive vasodilation (in this sense, they are the opposite of standard headaches, which are caused by vasoconstriction). The current SOCs for migraines, pretty much across the board, are vasoconstrictor drugs. They work to alleviate the symptoms, but are very risky in patients with cardiovascular problems. Vasoconstriction can bring on cardiac arrest, and so for patients that fall into this category, there are few options other than standard painkillers, which don’t do all that much in vasodilative pain.
Lasmiditan targets what are called 5‑HT1F receptors, which are expressed in the trigeminal nerve pathway. This nerve pathway plays a key role in the transmission and amplification of pain, so by inhibiting the receptors, the drug – theoretically – serves to mediate the pain amplification issues.
That’s the theory – what did the data show?
In short, it works. The primary endpoint focused on pain compared to a placebo, measured against a two-hour timeframe post administration. The drug outperformed placebo by more than 100% at the higher dose, and by just shy of 100% at the lower dose, over a control arm in the trial. P value was <0.001, so statistical significance is no issue.
The secondary endpoint looked at what’s called the most bothersome associated symptom (MBS) of the migraine, which generally includes nausea, phonophobia or photophobia, at the two-hour point post-dosing. Again, this was a hit. In the placebo arm, 29% of patients were MBS free after two hours’ post-administration. In the active arm, low dose, this rose to 40.9%, and in the high dose, 40.7%. Again, stat significance proved no issue on this endpoint.
Safety proved no problem, with the drug being generally well tolerated across the tested population and 91% of the treatment emergent AEs (TEAEs) being mild or moderate in nature – dizziness, nausea, fatigue, that sort of thing. Compare this to the TEAEs associated with vasoconstrictive SOCs in cardiac patients, and it’s a very clean profile. Even in non cardiac risk patients, it’s a clean profile.
So what are the implications of the data?
Well, it looks as though the drug is a shoo-in for approval, and the focus now shifts to putting together an executable marketing strategy. That, or finding a partner to market the drug for CoLucid Pharmaceuticals Inc (NASDAQ:CLCD). The company isn’t exactly short on cash – $14 million at June 30 – but it’s far from capitalized sufficiently to fund a marketing campaign in a space as saturated as migraine pain relief, and so a raise or a partner will be necessary. A raise will be dilutive, of course, but the value added (if the company can execute on a campaign successfully) should mitigate some of this dilutive risk. A partner is probably the more attractive option for shareholders right now, at least those that are looking nearer term, as an injection of upfront capital would boost the company’s market capitalization further, beyond the triple digit gains recorded on the latest data release.
We now look to NDA submission and PDUFA as near term catalysts. One to watch.
Note: This article is written by Mark Collins and originally published at Market Exclusive.