Company Enrolling Phase 2b Trial of Metformin Delayed Release for Type 2 Diabetes
SAN DIEGO, Oct. 1, 2015 – Elcelyx Therapeutics has raised $40 million in a Series E financing following receipt of guidance from the U.S. Food and Drug Administration regarding the late-stage development of product candidate Metformin Delayed Release (Metformin DR). Proceeds from new investors Sailing Capital, certain investment funds for which Clough Capital Partners, L.P. serves as investment manager, and all existing investors, support the immediate initiation of a large Phase 2b, dose-ranging clinical trial to evaluate Metformin DR. An oral agent, Metformin DR is under development to fill the unmet needs of the 40 percent of type 2 diabetes patients who cannot currently use metformin due to contraindications or poor tolerability.
The Series E financing was led by Hong Kong-based global private equity firm Sailing Capital, which invests in market leaders across a range of industries, including healthcare, technology, high‑end manufacturing, and consumer. Clough Capital Partners, L.P. is a Boston-based global investment management firm. Elcelyx's existing investors Morgenthaler Ventures, Kleiner Perkins Caufield & Byers, Technology Partners, and GSM Fund LLC also participated in the round.
"Sailing Capital invests in companies with specialized technologies that can make a major impact on their respective industries. Elcelyx's discovery that metformin can be formulated to target its primary site of action in the gut presents a very compelling healthcare opportunity," said James Liu, president and chief executive officer of Sailing Capital. "We look forward to supporting Elcelyx's development of Metformin DR for the millions of type 2 diabetes patients worldwide who cannot take currently marketed metformin," added Liang Tsui, managing director and partner of Sailing Capital.
"As we close our largest-ever financing round, Elcelyx is well positioned with a clearly defined development and regulatory path for Metformin DR," said Alain Baron, M.D., president and chief executive officer of Elcelyx. "We've begun the first trial of our late-stage clinical program designed to document Metformin DR's unique product attributes, namely the potential for use by renally impaired patients and a favorable gastrointestinal tolerability profile."
Concurrent with the financing, Elcelyx has appointed Mr. Tsui to the board of directors, joining current board members Ralph "Chris" Christoffersen, Ph.D. (chairman), Rick Barry, Jim Glasheen, Ph.D., Ginger L. Graham, and Dr. Baron.
Elcelyx plans to enroll approximately 550 patients in the Phase 2b dose-ranging study. This trial is expected to be followed by two pivotal Phase 3 studies, one of which will include type 2 diabetes patients with moderate renal impairment.
Despite the position of international diabetes associations and leading experts in the field that metformin is the preferred initial and foundational agent for the treatment of type 2 diabetes, approximately 40 percent of the 18 million treated patients in the United States are not benefiting from metformin therapy. The two most common reasons cited by physicians are contraindication due to renal impairment, and gastrointestinal intolerance that leads to discontinuation or dose reduction. Metformin DR achieves its glucose-lowering effects by targeting the lower bowel and limiting absorption into the blood, thereby providing the benefits of metformin without the systemic exposure-related health risks posed to patients with kidney impairment.
In Elcelyx's previous Phase 2 study, various doses of Metformin DR were compared to placebo or Metformin Extended Release (XR) in patients with type 2 diabetes. Metformin DR exhibited a 40 percent increase in apparent potency compared to Metformin XR and statistically significant and sustained reductions in fasting plasma glucose levels over 12 weeks compared to placebo. Treatment was generally well tolerated, with adverse events consistent with those described in the prescribing information for currently available metformin products. Results of this and earlier Metformin DR clinical studies were recently published in Diabetes Care.
About Sailing Capital
Founded in 2012, Hong Kong-based Sailing Capital is the first global private equity fund with its initial capital raised in Chinese Renminbi. Sailing Capital was initiated by Shanghai International Group primarily for investment outside of the Chinese domestic market. Sailing Capital's initial fund is targeted at US$ 8 billion of which US$ 1.9 billion has been raised in a first closing. Sailing Capital's portfolio company investments can take the form of equity, equity-linked, mezzanine and/or debt capital contributed on a full acquisition, majority or minority basis. Sailing Capital's investment strategy focuses on the healthcare, technology, high-end manufacturing, and consumer sectors. For more information, visit www.sailing-capital.com/hk.
About Elcelyx Therapeutics
Elcelyx Therapeutics is developing therapeutic agents based on the finding that modulation of the neuro-enteroendocrine system of the gut, including L-cells, amplifies the release of hormones such as those that play an important role in glucose regulation. This discovery affords a potentially safety advantaged platform to develop novel therapies as well as re-position existing therapies to meet serious unmet needs. Elcelyx's Metformin Delayed Release (Metformin DR) releases metformin in the gut instead of systemically, reducing bioavailability while still achieving efficacy. In two previous Phase 2 studies, Metformin DR lowered glucose and was well tolerated in patients with type 2 diabetes. For more information, visit www.Elcelyx.com.