Will SAMURAI Spell Relief For CoLucid Investors?

(RTTNews) - Shares of CoLucid Pharmaceuticals Inc. (CLCD), which are up nearly 32% year-do-date, touched an all-time high of $11.00 on Friday in the run up to the release of phase III trial results of its lead product candidate Lasmiditan.

Lasmiditan is the first in a new class of migraine therapies called "ditans". It is being developed in two formulations: an oral medication for the acute treatment of migraine in adults, and also as intravenous formulation for administration by health care professionals.

Two pivotal phase III clinical trials of Lasmiditan, known as SAMURAI and SPARTAN, and a phase III long-term, open-label trial, dubbed GLADIATOR, are underway.

The SAMURAI trial, initiated in April 2015, is designed to evaluate the safety and efficacy of Lasmiditan (100 mg and 200 mg) in up to 1,483 migraine patients compared to placebo two hours after dosing. The primary endpoint is freedom from migraine headache pain and the key secondary endpoint is freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia).

Top-line data from the SAMURAI trial are expected to be released during this week.

The SPARTAN study was initiated in May of this year, with the objective of evaluating the safety and efficacy of Lasmiditan (50 mg, 100 mg and 200 mg) in comparison to placebo two hours after dosing on freedom from migraine headache pain, which is the primary endpoint, and on freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia), which is the key secondary endpoint.

Top-line results from the SPARTAN study are expected in mid-2017.

The GLADIATOR study was initiated last October. Migraine patients who complete CoLucid's SAMURAI and SPARTAN studies are eligible to enroll in GLADIATOR.

GLADIATOR is expected to enroll up to a total of 2,580 subjects, who will be randomized to receive 100 mg or 200 mg of Lasmiditan, and treated for up to eight migraine attacks per month for one year.

Migraine is a debilitating neurological disease characterized by throbbing pain in one area of the head, which may be accompanied by nausea and extreme sensitivity to light and sound. An estimated 36 million Americans are living with migraine. It is said that migraine patients have a 55% higher incidence of Coronary Artery Disease events than the general population.

While Triptans, the current standard of care to treat migraine, work by inducing vasoconstriction of the blood vessels of the brain, CoLucid's Lasmiditan is designed to offer effective treatment for migraine through a non-vasoconstrictive mechanism of action.

If all goes well as planned, CoLucid's Lasmiditan will be a new addition to the armamentarium of migraine treatment.

Founded in 2005, CoLucid went public on the NASDAQ Global Market on May 6, 2015, offering its shares at a price of $10.00 each.

CLCD has thus far hit a low of $3.57 and a high of $11.00. The stock closed friday's trading 4% higher at $10.66.