Washington Editor

Enanta Pharmaceuticals Inc. raised $20 million in new financing to help carry its lead candidate, EP-013420, a first-in-class bridged bicyclic ketolide antibiotic for community respiratory tract infections, through Phase I development.

The $20 million is in addition to the $12 million Enanta reported raising in January, bringing the total to $32 million this year. The latest funding consists of a final close of the Series E round (Enanta's third institutional round) plus an undisclosed equity investment made by Shionogi & Co. Ltd. as part of an agreement to be Enanta's strategic partner in Asia for EP-013420. (See BioWorld Today, Jan. 15, 2004, and July 28, 2004.)

Since its inception in 1998, Enanta, of Watertown, Mass., has raised $77 million, Jay Luly, company president and CEO, told BioWorld Today. He said the firm has more than a year's cash.

Enanta now is positioned to take EP-013420 through Phase Ia and Ib trials, and to advance its discovery pipeline, which has a number of programs including one targeting macrolides and ketolides for the hospital, Luly said. All candidates were discovered and are owned by Enanta.

EP-013420 Phase I studies recently were initiated and are expected to run until early next year. Luly anticipates reporting some data later this year.

About a month ago, privately held Enanta and Shionogi, of Osaka, Japan, signed a deal giving the latter rights to EP-013420 in Japan and certain East Asian countries in exchange for an up-front cash payment and the equity investment disclosed Tuesday.

"Beyond the validation, we feel the financing that Shionogi has contributed really helps align the incentives of our partner and obviously it strengthens our near-term cash position significantly," Luly said. "We also feel the Phase I trial really represents a very significant value-inflection point for the company, because predicting human efficacy of antibiotics is fairly straightforward once you have a great Phase I package."

Indeed, marrying favorable preclinical work with a positive Phase I package "shakes a lot of risk out of a product like this," Luly said. Because it's a validated target, "what you are really looking at is if the compound has good pharmacokinetics and good safety and tolerability, and if those boxes check off, it does make a very compelling package and gives a lot of confidence going in to Phase II."

Meanwhile, Luly said he expects to bring on another partner to help take the candidate through community respiratory tract infection late-stage development.

Potentially, EP-013420 could be used to treat community-acquired pneumonia, acute exacerbation of chronic bronchitis, acute sinusitis, tonsilitis/pharyngitis and otitis media, the company said. Enanta designed the candidate to have optimal pharmacokinetics and to provide broad treatment against respiratory pathogens, including several multidrug-resistant strains for which traditional macrolides, penicillin and fluoroquinolones are no longer effective.

Other participants in the financing were Techno Venture Management, of Munich, Germany; Oxford Bioscience Partners, of Boston; BioVentures Investors, of Cambridge, Mass.; and Global Biomedical Partners, of New York.

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