|Lumena CEO Mike Grey|
San Diego biotech Lumena Pharmaceuticals has nailed down a $45 million B round with plans to move forward with treatments for two liver diseases, one a painful orphan condition and the other a fast-spreading cause célèbre in the biotech world.
With the cash, Lumena will bankroll ongoing mid-stage studies for LUM001, a drug designed to do away with built-up bile acids that can cause major damage for patients with cholestatic liver disease, a rare ailment for which the only other treatment is surgery, leaving sufferers with an abdominal opening to drain bile into an ostomy bag. Meanwhile, Lumena plans to get LUM002, its treatment for nonalcoholic steatohepatitis (NASH), into Phase II trials later this year, giving the biotech a play in one of the industry's most-watched disease areas.
LUM001 began its life as a would-be cholesterol treatment, but, after failing to move the efficacy needle in trials on more than 1,400 patients, ex-owner Pfizer ($PFE) pulled the plug on that indication. But investigators found that the drug did have quite an effect on bile levels, and so Lumena licensed it and got to work on cholestatic liver disease, launching Phase II trials on adult and pediatric patients with plans of wrapping mid-stage work this year and filing an NDA in 2016.
As for LUM002's potential, there are currently no approved treatments for NASH, a liver-wrecking disease caused by poor diet, and with rates on the rise around the globe, the disorder has become a high-profile target for drug developers. Early this year, Intercept Pharmaceuticals ($ICPT) watched its shares nearly triple in value on the strength of excellent Phase IIb results for a NASH-treating candidate, and Lumena is betting its Sanofi ($SNY)-licensed compound can follow suit.
Lumena figures its latest fundraiser will carry it through Phase II for both drugs, and CEO Mike Grey told FierceBiotech at this year's J.P. Morgan Healthcare conference that the company will likely seek out a partner at some point to help get its treatments across the finish line.
New investor New Enterprise Associates led Lumena's Series B, joined by first-time backers Adage Capital Management and RA Capital Management, plus existing stakeholders Pappas Ventures, RiverVest Venture Partners and Alta Partners. The raise follows a $23 million round closed last year and brings Lumena's total financing to $78 million, the biotech said.
- read the announcement