July 25, 2016 3:06 AM ET

Biotechnology

Company Overview of CoLucid Pharmaceuticals, Inc.

Company Overview

CoLucid Pharmaceuticals, Inc., a biopharmaceutical company, develops small molecules for the acute treatment of migraine. Its lead product candidate is Lasmiditan, an oral tablet that is in Phase III clinical program for the acute treatment of migraine headaches in adults. The company is also developing IV lasmiditan, which is in Phase II clinical trial for the acute treatment of headache pain associated with migraine in adults in emergency room and other urgent care settings. CoLucid Pharmaceuticals, Inc. was founded in 2005 and is headquartered in Cambridge, Massachusetts.

222 Third Street

Suite 1320

Cambridge, MA 02142

United States

Founded in 2005

7 Employees

Phone:

857-285-6495

Key Executives for CoLucid Pharmaceuticals, Inc.

Chief Executive Officer, President and Director
Age: 50
Total Annual Compensation: $499.6K
Chief Financial Officer and Treasurer
Age: 41
Total Annual Compensation: $261.1K
Head of Clinical and Regulatory Operations
Age: 57
Total Annual Compensation: $274.7K
Head of Business Development and Strategy
Age: 64
Total Annual Compensation: $120.0K
Compensation as of Fiscal Year 2015.

CoLucid Pharmaceuticals, Inc. Key Developments

CoLucid Pharmaceuticals, Inc. Announces Last Patient Randomized in Samurai Phase 3 Pivotal Trial of Lasmiditan in Migraine

CoLucid Pharmaceuticals, Inc. announced that the last patient has been randomized in its SAMURAI study, the company's first Phase 3 pivotal trial of lasmiditan. Per the SAMURAI protocol, the last patient randomized will have up to eight weeks to complete the study. SAMURAI top-line data are expected to be released when available in the third quarter of 2016, with more detailed results to be presented at a symposium during the 5thEuropean Headache and Migraine Trust International Congress (EHMTIC 2016) taking place in Glasgow, Scotland on September 17th, 2016. SAMURAI is the first of two pivotal Phase 3 clinical trials of lasmiditan oral tablets. The objectives of SAMURAI are to evaluate the safety and efficacy of lasmiditan (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. SAMURAI is a randomized, double-blind, placebo-controlled parallel group study. The study is expected to treat a single migraine in up to 1,483 migraine patients with lasmiditan at approximately 80 U.S. sites. Patients include those with migraine who have cardiovascular risk factors or cardiovascular disease. At least 80% of all migraine patients enrolled in SAMURAI had multiple risk factors for cardiovascular disease.

CoLucid Pharmaceuticals, Inc. Presents at Jefferies 2016 Healthcare Conference, Jun-08-2016 03:30 PM

CoLucid Pharmaceuticals, Inc. Presents at Jefferies 2016 Healthcare Conference, Jun-08-2016 03:30 PM. Venue: The Grand Hyatt Hotel, New York, New York, United States.

CoLucid Pharmaceuticals, Inc. Announces Initiation of Second Phase 3 Pivotal Trial of Lasmiditan in Migraine

CoLucid Pharmaceuticals, Inc. announced that the first patient has been randomized in its SPARTAN study, the company’s second Phase 3 pivotal trial of lasmiditan. The objective of SPARTAN is to evaluate 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. SPARTAN is a randomized, double-blind, placebo-controlled parallel group study. The study is expected to treat a single migraine in up to 2,226 migraine patients with lasmiditan at approximately 140 sites in the U.S., United Kingdom and Germany. CoLucid expects migraine patients enrolled in SPARTAN will include those who also have one or more cardiovascular risk factors, stable cardiovascular disease or known coronary artery disease (“CAD”). SPARTAN has been granted a Special Protocol Assessment (“SPA”) agreement with the U.S. Food and Drug Agency (“FDA”). Top-line results from SPARTAN are expected in mid-2017. Lasmiditan has been designed to be effective in the acute treatment of migraine headaches in adults without the vasoconstrictor activity associated with previous generations of migraine therapies. It selectively targets 5-HT1F receptors expressed in the trigeminal pathway. Lasmiditan has been given the generic stem name “ditan,” which distinguishes it from other drug classes, including triptans, the current standard of care for migraine. CoLucid is currently enrolling patients in SAMURAI, its first of two pivotal Phase 3 clinical trials. The objectives of SAMURAI are to evaluate the safety and efficacy of lasmiditan (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. SAMURAI is a randomized, double-blind, placebo-controlled parallel group study. The study is expected to treat a single migraine in up to 1,483 migraine patients with lasmiditan at approximately 80 U.S. sites. Patients will include those with migraine who have cardiovascular risk factors or cardiovascular disease. At the enrollment mid-point at least 80% of all migraine patients enrolled in SAMURAI had multiple risk factors for cardiovascular disease. SAMURAI is being conducted under a SPA agreement with the FDA. Lasmiditan is designed to address major unmet medical needs in migraine patients who are poorly served by currently available therapies, including patients with cardiovascular risk factors or cardiovascular disease that may not be able to take triptans. CoLucid is also currently enrolling patients in GLADIATOR, a Phase 3 long-term, open-label trial of lasmiditan. GLADIATOR’s objective is to evaluate the safety and efficacy of lasmiditan, as well as resource utilization, functional outcomes and disability. Migraine patients who complete CoLucid’s ongoing first Phase 3 pivotal trial, SAMURAI, as well as the Company’s second Phase 3 pivotal trial, SPARTAN, will be 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. Based on the results of GLADIATOR, CoLucid intends to build an appropriate safety database to support a New Drug Application (“NDA”) for lasmiditan. At the time of the NDA submission, it is anticipated that there will be more than 15,000 patient exposures to lasmiditan in the entire clinical program. Migraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. An estimated 36 million Americans suffer from migraine. Migraine can be extremely disabling and costly, accounting for more than an estimated $20 billion in direct (e.g., doctor visits, medications) and indirect (e.g., missed work, lost productivity) expenses each year in the United States.

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