CoLucid Pharmaceuticals ($CLCD) was up about 75% in premarket trading after it disclosed Phase III data for its lasmiditan to treat migraine. It’s expected to have the next set of top-line pivotal data during the second half of next year from another trial that’s currently enrolling. Upon successful completion of both pivotal trials, the company has said it will submit for FDA approval.
Lasmiditan is expected to offer an alternative to triptans, which are the current standard of care to treat migraine. Triptans carry a warning for patients with cardiovascular risk factors or diseases; CoLucid is hoping to avoid that issue since, unlike triptans, lasmiditan doesn’t cause vasoconstriction. In addition, CoLucid is aiming to treat the roughly 40% of migraine patients who don’t respond to triptans or other existing therapies.
The company has boasted that lasmiditan has the first new mechanism of action for migraine to emerge in the last 20 years. It targets the 5-HT1F receptors expressed in the trigeminal nerve pathway, penetrating the central nervous system to work to block the sensation of pain.
The more than 2,200-patient Phase III SAMURAI study met the primary endpoint of efficacy for low-dose and high-dose lasmiditan versus placebo based on migraine headache pain two hours after dosing. It also met the secondary endpoint of freedom from the most bothersome migraine symptom two hours after dosing.
The second 2,200-plus patient pivotal trial, SPARTAN, is evaluating three doses, with an additional lower-dose arm but with the same primary and secondary endpoints as the SAMURAI trial. It’s expected to examine a patient subgroup of those with cardiovascular risk factors, stable cardiovascular disease or known coronary artery disease.
“Lasmiditan has the potential to become an important treatment option, particularly for migraine patients at high risk for cardiovascular disease,” Dr. Richard Lipton, vice chair of neurology and a professor of epidemiology and population health at Albert Einstein College of Medicine and director of Montefiore Headache Center, said in a statement. “In these patients, available acute migraine treatments such as triptans and ergot alkaloids may be contraindicated or have precautions and warnings because of their vasoconstrictive effects.”
CoLucid went public with a $55 million IPO last May at $10 per share; the positive pivotal trial data pushed its share price up to almost $19 and its valuation up to about $300 million. Its major venture investors included Care Capital, Novo A/S, Domain Partners, TVM Life Science Ventures and Trialthlon Medical Ventures.