– USA, NC – 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 is developing oral lasmiditan for the acute treatment of migraine headache and intravenous Lasmiditan for treatment of headache pain by health care professionals. Proceeds from the Series C will be used to fund the Company’s Phase 3 program for oral Lasmiditan, to include the first pivotal study, COL MIG-301 “SAMURAI”, for the acute treatment of migraine. Previously, the Company announced that it had reached agreement on a Special Protocol Assessment (“SPA”) with the U.S. Food and Drug Administration (“FDA”) for SAMURAI. The objective of SAMURAI is to evaluate the safety and efficacy of two doses of Lasmiditan in comparison to placebo for the acute treatment of migraine. Migraine patients with risk factors for unrecognized cardiovascular disease and some forms of stable cardiovascular disease will be included in the study.
“Lasmiditan represents the first new mechanism of action for the acute treatment of migraine in over 20 years. Given its non-vasoconstrictive mechanism of action, lasmiditan has the opportunity to provide effective relief for migraine sufferers without the potential liabilities of vasoconstriction associated with triptans. We are thrilled to have such high quality new investors join our outstanding syndicate,” said Thomas P. Mathers, CoLucid’s Chief Executive Officer.
“The team at CoLucid has demonstrated singular focus in developing lasmiditan and defining a highly differentiated development pathway. Lasmiditan is a promising new chemical entity in late-stage development with a new mechanism of action for the acute treatment of migraine. The SPA for SAMURAI is a game changer, and lasmiditan has the opportunity to provide benefit for a serious and disabling condition that affects more than 12% of the worldwide population. We are proud to add CoLucid to our portfolio of TVM LSV VII investments,” said Dr. Luc Marengere, Managing Partner of TVM Capital Life Science in Montreal.
ABOUT LASMIDITAN
Lasmiditan has been designed to deliver efficacy in acute migraine without the vasoconstrictor activity associated with previous generations of migraine therapies. It selectively targets 5-HT1F receptors expressed in the trigeminal pathway. Its novel chemical class and differentiated site and mechanism of action led to lasmiditan’s designation as a “ditan,” a new drug class, by the INN and USAN.
CoLucid has successfully completed six clinical studies for Lasmiditan, including a Phase 2b study treating a single migraine attack in 391 patients, as well as a TQTc study. Phase 3 development will address major unmet medical needs in patients who are poorly served currently by available therapies to include patients with risk factors for cardiovascular disease who may not be able to take triptans.
The SPA agreement for SAMURAI 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.
ABOUT MIGRAINE
Migraine is ranked as the seventh highest cause of global disability and in the top 10 causes of disability in 14 of 21 world regions studied, according to findings by the Global Burden of Disease Survey 2010 conducted by the World Health Organization. It is the leading cause of disability among neurological disorders. An estimated 36 million Americans have migraine, which is more than have asthma or diabetes combined. Migraine can be extremely disabling and costly, accounting for more than $20 billion in direct (e.g. doctor visits, medications) and indirect (e.g. missed work, lost productivity) expenses each year in the United States.
ABOUT COLUCID PHARMACEUTICALS, INC.
CoLucid was founded by Pappas Ventures and is developing oral Lasmiditan for the acute treatment of migraine headache and intravenous Lasmiditan for treatment of headache pain by health care professionals.
CoLucid is partnered with ILDONG Pharmaceutical Co, Ltd, under a distribution and supply agreement for Lasmiditan, in South Korea and Southeast Asia.
ABOUT TVM CAPITAL LIFE SCIENCE
TVM Capital Life Science is providing venture capital to the international pharmaceutical, biopharmaceutical and medical technology industries with more than 30-years of transatlantic investment track record and in excess of US$1.3bn under management. The life science team boasts more than 120 investments and over 90 exits in the last 30 years, including more than 40 initial public offerings on all major U.S. and European stock exchanges, and combines long-standing international investment and company building experience with their track record of dedicated board work, extensive global networks in the world of life science research and product development and a direct knowledge of the local markets. TVM Capital Life Science currently invests from its 7th fund generation, TVM Life Science Ventures VII, with an integrated team of investment professionals. Fund generations III to VI are managed by managing partners, Dr. Helmut M. Schühsler and Dr. Hubert Birner out of the Munich office. The new fund TVM LSV VII is advised by Dr. Hubert Birner and Dr. Luc Marengere out of Munich and Montreal.
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