Domain finds unmet need in CF

Print 15 June 2015
Steve Edelson / BioCentury

Domain Associates has decided the best way to play the cystic fibrosis space is to find a molecule that can be combined with the ever-increasing number of cocktails emerging from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX). To do so, Domain led a $40 million series D round for Celtaxsys Inc. last week, marking its first investment in CF.

Celtaxsys’ CTX-4430 is a once-daily oral inhibitor of leukotriene A4 hydrolase (LTA4H) that is expected to start Phase II testing next half to preserve lung function in CF patients.

LTA4H is an enzyme involved in the production of the inflammatory mediator leukotriene B4 (LTB4).

“The one thing that doesn’t exist in the cystic fibrosis research field is an anti-inflammatory,” said Celtaxsys President and CEO Greg Duncan. “That’s significant because the sad fact is lung inflammation is what sends patients to the hospital and it’s what they die of.”

Duncan said the “vast majority” of the series D proceeds will go towards the Phase II CF trial, as will the entirety of a $5 million grant from the Cystic Fibrosis Foundation’s Cystic Fibrosis Foundation Therapeutics (CFFT) drug development affiliate.

“CTX-4430 is not only the lead anti-inflammatory in the CF research area, it’s also complementary to the other therapies in the field,” said Duncan.

CF therapies include antibiotics as well as genotype-specific molecules like Vertex’s Kalydeco ivacaftor, a potentiator of cystic fibrosis transmembrane conductance regulator (CFTR), and lumacaftor (VX-809), a CFTR corrector. A combination of the two is under FDA review as Orkambi.

“Vertex has done a great job with their pipeline and advanced a lot of science, but CF is still underserved. Except for these genotype-specific products there’s been nothing new for years,” said Domain’s Nicole Vitullo, who joined Celtaxsys’ board. “We got intrigued by Celtaxsys’ new mechanism of action in the space that will be agnostic to genotype. It’s background therapy for potentially everyone.”

According to Duncan, Celtaxsys has completed drug-drug interaction studies showing that CTX-4430 does not affect levels of other CF treatments that he didn’t identify.

Celtaxsys also is running a Phase II trial of CTX-4430 to treat acne vulgaris, with results expected in 1Q16. If positive, Duncan said the company likely would develop a topical formulation for further acne trials.

He said the series D proceeds provides runway through 1Q18.

Other investors in the round included Lumira Capital, RMI Partners, Masters Capital Management and the Georgia Research Alliance Venture Fund.

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