CoLucid Pharmaceuticals Announces Initiation of Phase 3 Long-Term, Open-Label Trial of Lasmiditan in Migraine.

CoLucid Pharmaceuticals Announces Initiation of Phase 3 Long-Term, Open-Label Trial of Lasmiditan in Migraine.

CAMBRIDGE, Mass., Oct. 8, 2015 – CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches in adults, announced today that the first patient has been randomized in the Company’s GLADIATOR study, a Phase 3 long-term, open-label trial of lasmiditan.

The objective of GLADIATOR 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, scheduled to commence in the first half of 2016, 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.

CoLucid Pharmaceuticals Announces Pricing of Initial Public Offering

BURLINGTON, Mass., May 6, 2015 – CoLucid Pharmaceuticals, Inc. (“CoLucid”) (CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches, announced today the pricing of its initial public offering of 5,500,000 shares of common stock at a public offering price of $10.00 per share.

CoLucid Pharmaceuticals Announces Initiation of First Phase 3 Pivotal Trial of Lasmiditan in Migraine

First Patient Randomized in SAMURAI STUDY Trial Being Conducted Under Special Protocol Assessment Agreement with FDA

BURLINGTON, Mass., April 28, 2015 – CoLucid Pharmaceuticals, Inc., a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches in adults, announced today that the first patient has been randomized in its SAMURAI study, the Company’s first Phase 3 pivotal trial of lasmiditan.

The objective of SAMURAI is 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 our primary endpoint, and on freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia), which is our secondary endpoint. SAMURAI is a randomized, double-blind, placebo-controlled parallel group study. The study is expected to treat up to 1,483 migraine patients with lasmiditan at approximately 70 U.S. sites for approximately 12 months. We expect patients will include those with migraine who also have cardiovascular risk factors or cardiovascular disease. SAMURAI is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.

CoLucid Pharmaceuticals, Inc., Raises $37.1 Million in Series C Preferred Stock Offering

Durham, NC, January 13, 2015/PRNewswire/ — CoLucid Pharmaceuticals, Inc., today announced that it has completed a $37.1 million Series C preferred stock offering.  The financing was led by TVM Capital Life Science, based in Montreal and Munich,and included participation from new investors Novo Ventures and Auriga Partners. All of the Company’s existing investors also participated in the Series C, including Pappas Ventures, Domain Associates, Care Capital, Triathlon Medical Ventures and Pearl Street Ventures. Joining the board of directors will be Dr. Luc Marengere from TVM Capital Life Science and Dr. Martin Edwards from Novo Ventures.

CoLucid Pharmaceuticals, Inc., Announces Agreement from the FDA on a Special Protocol Assessment (SPA) for the Phase 3 Trial of Lasmiditan in Migraine Including Patients with Risk Factors for Cardiovascular Disease

Durham, NC, MAY 6, 2014/PRNewswire/ — CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, has reached agreement with the U.S. Food and Drug Administration (FDA) for the planned SAMURAI study. The objective of this trial is to evaluate the safety and efficacy of two doses of Lasmiditan in comparison to placebo for the treatment of acute migraine. Patients with risk factors for cardiovascular disease will be included in the study.

The SPA agreement includes two novel endpoints for the approval of acute migraine therapies—a primary endpoint of the proportion of patients who are free of headache pain at 2 hours and a key secondary endpoint of the proportion of patients who no longer suffer from their most bothersome associated symptom of migraine (nausea, photophobia, phonophobia) at 2 hours.

CoLucid Pharmaceuticals and ILDONG Pharmaceutical Enter into a Distribution and Supply Agreement for Lasmiditan, a Novel Agent for Acute Migraine

CoLucid Pharmaceuticals and ILDONG Pharmaceutical Enter into a Distribution and Supply Agreement for Lasmiditan, a Novel Agent for Acute Migraine

DURHAM, N.C., October 22, 2013 /PRNewswire/ — CoLucid Pharmaceuticals, Inc., and ILDONG Pharmaceutical Co., Ltd., announced today that they have entered into a distribution and supply agreement for Lasmiditan in South Korea and Southeast Asia.

Under the terms of the agreement, CoLucid will receive upfront and milestone payments in addition to consideration for product supply in exchange for exclusive rights to ILDONG for development and commercialization of Lasmiditan in the territory. ILDONG will be responsible for the costs and activities related to development and regulatory approvals in the territory and will also participate in key registration trials as part of the global development plan.

Pappas-backed CoLucid gets FDA accord

Durham-based CoLucid Pharmaceuticals, Inc. has reached an agreement with the U.S. Food and Drug Administration’s Division of Neurology Products on the strategy the young pharma will follow in developing its migraine drug candidate.

The drug, lasmiditan, is intended for patients with, or at risk of, cardiovascular disease, as well as patients who haven’t gotten help from some other treatments. Six clinical studies have been successfully completed so far, including a Phase 2b double blind placebo study where the drug achieved its primary endpoint.

Durham-based Pappas Ventures launched the company in 2005. So far, CoLucid has raised about $50 million in multiple rounds, including more than $7 million last year to fund Phase 3 trials of lasmiditan.

Pappas-backed CoLucid gets FDA accord

 

September 19, 2012 

Durham-based CoLucid Pharmaceuticals, Inc. has reached an agreement with the U.S. Food and Drug Administration’s Division of Neurology Products on the strategy the young pharma will follow in developing its migraine drug candidate.

The drug, lasmiditan, is intended for patients with, or at risk of, cardiovascular disease, as well as patients who haven’t gotten help from some other treatments. Six clinical studies have been successfully completed so far, including a Phase 2b double blind placebo study where the drug achieved its primary endpoint.

Durham-based Pappas Ventures launched the company in 2005. So far, CoLucid has raised about $50 million in multiple rounds, including more than $7 million last year to fund Phase 3 trials of lasmiditan.

CoLucid Pharmaceuticals Details Phase 3 Development Strategy for Lasmiditan to Address Major Unmet Needs in Acute Migraine Therapy

Durham, NC, September 18, 2012 /PRNewswire/ — CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, has reached agreement with the Food and Drug Administration’s Division of Neurology Products concerning the development strategy for lasmiditan at a recently completed End of Phase 2 meeting. Lasmiditan is a novel therapy for acute migraine and will initially be developed to address major unmet needs in two patient populations who are poorly served by currently available therapies: 1) patients with risk factors for cardiovascular disease and those with diagnosed cardiovascular disease and 2) patients who have not had adequate efficacy from triptans. The development program will be confirmed via the Special Protocol Assessment process.

Lasmiditan is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies such as triptans. Lasmiditan is a member of a novel chemical class called “ditans” and, unlike triptans, penetrates the central nervous system (CNS) and selectively targets receptors expressed in the trigeminal pathway. Lasmiditan does not interact with vasoconstrictor receptors on peripheral blood vessels which are activated by triptans.

CoLucid has further evaluated lasmiditan’s cardiovascular profile by recently completing a Thorough QT/QTc study (TQT) titled COL MIG-105: A Randomized, Double-blind, Placebo-controlled, 4-way Crossover Study to Compare the Effects on the Cardiac De- and Re-polarization Duration as well as other Cardiac Safety Parameters of Two Doses of Oral Lasmiditan (100 mg and 400 mg) with those of Moxifloxacin (400 mg) and Placebo in Healthy Subjects. The statistical evaluation of the primary variable revealed that lasmiditan caused no significant QT prolongation either at 100 mg (the putative therapeutic dose) or at 400 mg (supratherapeutic dose), whereas moxifloxacin caused a QT prolonging effect similar to that seen in published studies and thus assay sensitivity for this study was demonstrated. No pro-arrhythmic effect of lasmiditan was observed in the assessments of ECGs made by a cardiologist, and safety and tolerability were similar to observations in previous studies.

”We believe that lasmiditan’s unique central mechanism of action provides acute migraine relief without the associated chest symptoms and vasoconstrictor effects seen with triptans. Lasmiditan could be a very important treatment for those patients who are warned not to take triptans, such as patients with high blood pressure or high cholesterol, obese patients or those with diabetes, smokers and patients with a strong family history of coronary artery disease, post-menopausal women or men over 40 years of age,” commented Thomas P. Mathers, Chief Executive Officer. “There are a large number of acute migraine patients who do not respond to triptan therapy. Lasmiditan could provide an excellent therapeutic alternative for these patients who now frequently turn to opioids.”

About Lasmiditan

Six clinical studies have been successfully completed, including a Phase 2b double blind placebo controlled oral dose ranging study treating a single migraine attack. In the Phase 2b study, lasmiditan achieved its primary endpoint of reducing a moderate or severe headache at baseline to mild or none 2 hours after dosing (p<0.0001) in 391 patients. Differentiation of individual doses from placebo was seen as early as 30 minutes after dosing. Lasmiditan also achieved secondary endpoints, including relief of nausea, photophobia and phonophobia. Importantly, because there was no evidence of drug-related cardiovascular effects or chest symptoms in the previous six clinical studies, CoLucid expects that the pivotal Phase 3 studies will confirm that lasmiditan’s side effect profile is highly differentiated from triptans and ergotamines.

About CoLucid Pharmaceuticals, Inc.

CoLucid was founded in 2005 by Pappas Ventures to advance innovative drug candidates with the potential to provide safe and effective treatments for CNS disorders. The company’s investors include Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures. The company’s pipeline includes lasmiditan, a novel treatment for migraine headache. For more information, please visit CoLucid at www.colucid.com.

CoLucid Pharmaceuticals Details Phase 3 Development Strategy for Lasmiditan to Address Major Unmet Needs in Acute Migraine Therapy

Durham, NC, September 18, 2012 /PRNewswire/ — CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, has reached agreement with the Food and Drug Administration’s Division of Neurology Products concerning the development strategy for lasmiditan at a recently completed End of Phase 2 meeting. Lasmiditan is a novel therapy for acute migraine and will initially be developed to address major unmet needs in two patient populations who are poorly served by currently available therapies: 1) patients with risk factors for cardiovascular disease and those with diagnosed cardiovascular disease and 2) patients who have not had adequate efficacy from triptans. The development program will be confirmed via the Special Protocol Assessment process.

Lasmiditan is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies such as triptans. Lasmiditan is a member of a novel chemical class called “ditans” and, unlike triptans, penetrates the central nervous system (CNS) and selectively targets receptors expressed in the trigeminal pathway. Lasmiditan does not interact with vasoconstrictor receptors on peripheral blood vessels which are activated by triptans.

CoLucid has further evaluated lasmiditan’s cardiovascular profile by recently completing a Thorough QT/QTc study (TQT) titled COL MIG-105: A Randomized, Double-blind, Placebo-controlled, 4-way Crossover Study to Compare the Effects on the Cardiac De- and Re-polarization Duration as well as other Cardiac Safety Parameters of Two Doses of Oral Lasmiditan (100 mg and 400 mg) with those of Moxifloxacin (400 mg) and Placebo in Healthy Subjects. The statistical evaluation of the primary variable revealed that lasmiditan caused no significant QT prolongation either at 100 mg (the putative therapeutic dose) or at 400 mg (supratherapeutic dose), whereas moxifloxacin caused a QT prolonging effect similar to that seen in published studies and thus assay sensitivity for this study was demonstrated. No pro-arrhythmic effect of lasmiditan was observed in the assessments of ECGs made by a cardiologist, and safety and tolerability were similar to observations in previous studies.

”We believe that lasmiditan’s unique central mechanism of action provides acute migraine relief without the associated chest symptoms and vasoconstrictor effects seen with triptans. Lasmiditan could be a very important treatment for those patients who are warned not to take triptans, such as patients with high blood pressure or high cholesterol, obese patients or those with diabetes, smokers and patients with a strong family history of coronary artery disease, post-menopausal women or men over 40 years of age,” commented Thomas P. Mathers, Chief Executive Officer. “There are a large number of acute migraine patients who do not respond to triptan therapy. Lasmiditan could provide an excellent therapeutic alternative for these patients who now frequently turn to opioids.”

About Lasmiditan

Six clinical studies have been successfully completed, including a Phase 2b double blind placebo controlled oral dose ranging study treating a single migraine attack. In the Phase 2b study, lasmiditan achieved its primary endpoint of reducing a moderate or severe headache at baseline to mild or none 2 hours after dosing (p<0.0001) in 391 patients. Differentiation of individual doses from placebo was seen as early as 30 minutes after dosing. Lasmiditan also achieved secondary endpoints, including relief of nausea, photophobia and phonophobia. Importantly, because there was no evidence of drug-related cardiovascular effects or chest symptoms in the previous six clinical studies, CoLucid expects that the pivotal Phase 3 studies will confirm that lasmiditan’s side effect profile is highly differentiated from triptans and ergotamines.

About CoLucid Pharmaceuticals, Inc.

CoLucid was founded in 2005 by Pappas Ventures to advance innovative drug candidates with the potential to provide safe and effective treatments for CNS disorders. The company’s investors include Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures. The company’s pipeline includes lasmiditan, a novel treatment for migraine headache. For more information, please visit CoLucid at www.colucid.com.