CoLucid Pharmaceuticals Raises $7.5 Million of Planned $9.5 Million

CoLucid Pharmaceuticals Raises $7.5 Million of Planned $9.5 Million

DURHAM, N.C., Aug. 30, 2011 /PRNewswire-iReach/ — CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced today that it has raised $7.5 million of a planned $9.5 million convertible note financing from its existing investors to support further late stage development of lasmiditan.  Participating in the financing were Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures.

“This financing provides important working capital for CoLucid to further advance lasmiditan into Phase 3 development,” remarked Thomas P. Mathers, Chief Executive Officer of CoLucid.  ”We are embarking on additional clinical studies to further differentiate lasmiditan’s safety profile from the triptan class of anti-migraine agents, as well as discussing with the FDA our final Phase 3 plans.” said Mr. Mathers.

The Company is speaking with potential partners and is interacting with the FDA, and plans to advance lasmiditan into pivotal studies in 2012.

About Lasmiditan

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.  Lasmiditan is a member of a novel chemical class called “ditans” and, unlike triptans, penetrates the central nervous system (CNS) and selectively targets 5-HT1F receptors expressed in the trigeminal pathway.  Lasmiditan does not interact with vasoconstrictor 5-HT1B/1D receptors activated by triptans.

Five clinical studies have been successfully completed outside of the U.S., including a Phase 2b double blind placebo controlled oral dose ranging study treating a single migraine attack which was completed in 2010. 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 five clinical studies, CoLucid expects the pivotal Phase 3 studies to 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, COL-204 for wake promotion, and a conjugated stigmine platform that has generated a series of preclinical candidates for the chronic pain, Alzheimer’s disease and psychiatric disorders. For more information, please visit CoLucid at www.colucid.com.

CoLucid Pharmaceuticals Raises $7.5 Million of Planned $9.5 Million

DURHAM, N.C., Aug. 30, 2011 /PRNewswire-iReach/ — CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced today that it has raised $7.5 million of a planned $9.5 million convertible note financing from its existing investors to support further late stage development of lasmiditan.  Participating in the financing were Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures.

CoLucid Pharmaceuticals Receives Clearance For Investigational New Drug (IND) Application For Lasmiditan For The Treatment Of Acute Migraine

CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced that it has received clearance to proceed with clinical studies of lasmiditan (formerly known as COL-144) under IND 103,420 from the Food and Drug Administration (FDA).

Lasmiditan is a first-in-class oral tablet formulation of a Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies. Lasmiditan is a member of a novel chemical class called “ditans”, and, unlike triptans, which target vasoconstrictor 5-HT1B receptors, lasmiditan penetrates the central nervous system (CNS) and selectively targets 5-HT1F receptors expressed in the trigeminal nerve pathway.

Five clinical studies have been successfully completed outside of the U.S., including a Phase 2b double blind placebo controlled dose ranging study treating a single migraine attack which was completed in 2010. 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 numerous secondary endpoints per other migraine symptoms such as nausea, photophobia and phonophobia. Importantly, lasmiditan’s side effect profile is highly differentiated from triptans and ergotamines, and there was no evidence of drug-related cardiovascular effects or chest symptoms in the previous five clinical studies.

“The migraine market, estimated at 30 million sufferers in the US, is an under-served market. No new class of therapies has been introduced for the treatment of acute migraine since the triptan class, which was first launched almost 20 years ago,” remarked Thomas P. Mathers, Chief Executive Officer of CoLucid. “Patient and physician feedback note that only a portion of migraine patients are adequately controlled on triptans, and patients would welcome a new product that could offer a rapid speed of onset, superior pain relief and/or a lack of cardiovascular side effects as compared to currently available products. In addition, due to their vasoconstrictor activity, triptans are contraindicated in patients with cardiovascular disease. Many neurologists and primary care physicians feel uncomfortable prescribing triptans because of their potential cardiovascular side effects. Lasmiditan may address these unmet needs with its novel mechanism of action, and we look forward to the results of the Phase 3 trials to confirm its rapid speed of onset, superior pain relief and lack of cardiovascular side effects,” said Mr. Mathers.

The Company is speaking with potential partners and is interacting with the FDA, and plans to advance lasmiditan into Phase 3 development.

CoLucid Pharmaceuticals Receives Clearance For Investigational New Drug (IND) Application For Lasmiditan For The Treatment Of Acute Migraine

 
August 20, 2011

CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced that it has received clearance to proceed with clinical studies of lasmiditan (formerly known as COL-144) under IND 103,420 from the Food and Drug Administration (FDA).

Lasmiditan is a first-in-class oral tablet formulation of a Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies. Lasmiditan is a member of a novel chemical class called “ditans”, and, unlike triptans, which target vasoconstrictor 5-HT1B receptors, lasmiditan penetrates the central nervous system (CNS) and selectively targets 5-HT1F receptors expressed in the trigeminal nerve pathway.

CoLucid in talks with partners for novel migraine treatment

Central nervous system drug development company CoLucid is currently in talks with potential partners who could take its investigational migraine headache treatment into late-stage clinical trials.

The company offered no details on the prospective drug partners, but said it does now have the U.S. Food and Drug Administration’s go-ahead to proceed with phase 3 trials. CoLucid’s lead drug candidate is lasmiditan, which is being developed as a new kind of migraine treatment that can offer headache relief without the cardiovascular side effects associated with triptans, the class of drugs currently used to treat migraines. Lasmiditan, part of a chemical class called “ditans,” more selectively targets the receptors that trigger migraines.

Durham, North Carolina-based CoLucid has raised about $40 million in venture capital from Pappas Ventures, Care Capital, Domain Associates, Pearl Street Venture Funds and Triathlon Medical Ventures. The company was founded in 2005 by Pappas Ventures.

Five clinical studies on lasmiditan have been completed outside the United States; a phase 2b study was completed last year. CoLucid is moving quickly on lasmiditan. When new CEO Thomas Mathers was hired in July, Art Pappas, chairman of CoLucid’s board of directors and managing partner at Pappas Ventures, said that Mathers would lead phase 3 development and commercialization plans for the compound.

CoLucid licensed lasmiditan from Eli Lilly (NYSE:LLY). Besides lasmiditan, CoLucid has preclinical candidates for the treatment of sleep/wake disorders, chronic pain, Alzheimer’s disease and psychiatric disorders.

CoLucid Appoints Thomas P. Mathers as Chief Executive Officer Read more: CoLucid Appoints Thomas P. Mathers as Chief Executive Officer – FierceBiotech http://www.fiercebiotech.com/press-releases/colucid-appoints-thomas-p-mathers-chief-executive-officer#i

DURHAM, N.C., July 15, 2011 /PRNewswire-iReach/ — CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced today the appointment of Thomas P. Mathers, 44, as Chief Executive Officer.

Mr. Mathers has more than 19 years of executive management, sales and marketing experience in the life sciences and medical device industry. He also serves on the Board of Directors for the Biotechnology Industry Organization (BIO), and as chairman of Declion Pharmaceuticals, a company which he co-founded. Prior to CoLucid, he served as president and CEO of Peptimmune, Inc. from 2003 to 2011. Founding CEO, James F. White, Ph.D. will continue his involvement with CoLucid as scientific director.

“Tom has extensive leadership skills and brings valuable strategic, operational and transactional experience to our team at a key inflection point in the company’s growth and development,” said Art Pappas, Chairman of the Board of Directors, and managing partner at Pappas Ventures. “Tom will lead the CoLucid team in formulating our phase 3 development and commercialization plans for lasmiditan,” he added.

During his career, Mr. Mathers has also held positions as president and CEO of Cell Based Delivery; vice president and general manager of Cardion AG; vice president of Strategic Development at Genzyme; and management positions at Snowden-Pencer and Pfizer, Inc. He holds several patents and patents pending and earned his BS in Engineering from the United States Military Academy at West Point, where he was a Dean’s List student and three-year starter on the football team as a defensive end. From 1988 to 1991 he served as captain in the United States Army and was awarded several medals for his services as an AH-64 Apache helicopter pilot in the Gulf War in the XVIII Airborne Corps.

“I am excited to join the CoLucid team and complete the development of lasmiditan, our breakthrough first in class treatment for acute migraine. This is an area of significant unmet need since many of the currently approved therapies have unwanted side effects and are contraindicated in some patients,” said Mr. Mathers.

About CoLucid Pharmaceuticals, Inc.

CoLucid was founded in August 2005 by Pappas Ventures to advance innovative drug candidates with the potential to provide safe and effective treatment for central nervous system (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 (COL-144), a novel treatment for migraine headache, and a conjugated stigmine platform that has generated a series of preclinical candidates for the treatment of sleep/wake disorders, chronic pain, Alzheimer’s disease and psychiatric disorders. For more information, please visit CoLucid at www.colucid.com.

CoLucid Pharmaceuticals, Inc. announces study data documenting oral efficacy of lasmiditan in the treatment of acute migraine attacks

CoLucid Pharmaceuticals, Inc., (“CoLucid”), an innovative biotechnology company focusing on therapies for central nervous system disorders, today announced that its investigational first-in- class Neurally Acting Anti-Migraine Agent (NAAMA), lasmiditan (also known as COL-144), a selective 5-HT1F receptor agonist, was effective when given orally to treat acute migraine attacks, as documented in a Phase IIb study. Results of this study will allow the selection of doses for pivotal Phase III studies of lasmiditan in the acute treatment of migraine, scheduled to begin in fourth quarter this year.

CoLucid Pharmaceuticals, Inc. announces study data documenting oral efficacy of lasmiditan in the treatment of acute migraine attacks

 

DURHAM, N.C., June 9, 2010 /PRNewswire/ — CoLucid Pharmaceuticals, Inc., (“CoLucid”), an innovative biotechnology company focusing on therapies for central nervous system disorders, today announced that its investigational first-in- class Neurally Acting Anti-Migraine Agent (NAAMA), lasmiditan (also known as COL-144), a selective 5-HT1F receptor agonist, was effective when given orally to treat acute migraine attacks, as documented in a Phase IIb study. Results of this study will allow the selection of doses for pivotal Phase III studies of lasmiditan in the acute treatment of migraine, scheduled to begin in fourth quarter this year.

Phase 2 Results of COL-144 Presented at European Headache and Migraine Trust International Congress 2008

 
LONDON, SEPT. 6, 2008 – CoLucid Pharmaceuticals, Inc., an innovative biotechnology company focusing on therapies for central nervous system disorders, announced Phase II results of its lead compound COL-144 in the treatment of acute migraine. Results demonstrated that COL-144 was safe and effective in relieving migraine headaches. COL-144 is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA), which unlike triptans, exhibits anti-migraine activity without causing vasoconstriction. COL-144 is a highly potent and selective 5HT1F receptor agonist. The studies were presented in poster presentations at the European Headache and Migraine Trust International Congress 2008 in London, Sept. 4-7, 2008.

CoLucid presents Phase 2 results of COL-144 at European Headache and Migraine Trust International Congress 2008

CoLucid Pharmaceuticals, Inc., an innovative biotechnology company focusing on therapies for central nervous system disorders, announced Phase II results of its lead compound COL-144 in the treatment of acute migraine. Results demonstrated that COL-144 was safe and effective in relieving migraine headaches. COL-144 is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA), which unlike triptans, exhibits anti-migraine activity without causing vasoconstriction. COL-144 is a highly potent and selective 5HT1F receptor agonist. The studies were presented in poster presentations at the European Headache and Migraine Trust International Congress 2008 in London, Sept. 4-7, 2008.