Washington Editor

Start-up firm Alba Therapeutics Corp. raised $30 million in a Series A round of financing to advance its lead product into clinical testing.

"We just filed an IND the Friday before last, so we're about to enter clinical trials," said Chris Jeffers, Alba's general counsel and vice president of intellectual property. "That's really the big branch point for us right now."

Spun out of the University of Maryland a year ago, the Baltimore company has focused its early efforts on modulating the zonulin pathway for inflammatory and immune-mediated diseases. Zonulin is a protein that regulates intercellular tight junctions, and research into the pathway, which serves as a biological epithelial and endothelial barrier between cells, is borne of a decade's worth of academic work performed by Alessio Fasano, a co-founder of Alba and its interim chief scientific officer. Intellectual property at the company, whose other co-founder and CEO is Blake Paterson, is licensed from the University of Maryland.

"One of the advantages of our zonulin pathway technology is that it's a pluripotential platform that has applications in a number of different, broad areas," Jeffers said of Alba's peptide agonists and antagonists. The former can be used as adjuvants for the delivery of drugs and vaccines by opening tight junctions through the zonulin pathway, while the latter can be used to treat acute and chronic inflammatory and immune conditions, such as celiac disease and Type I diabetes, which are characterized by inappropriate permeability.

Alba's near-term clinical plans are focused on moving an antagonist labeled AT-1001 into initial studies for celiac disease, with trials for Type I diabetes to follow in about six months. Jeffers said those diseases are caused by "an elevated zonulin level, which would cause an aberrant increase in intestinal permeability. So many more still-potent molecules get through from the intestine, causing immune responses that generate autoimmune responses and manifest themselves in autoimmune diseases." AT-1001 is designed to keep zonulin from opening tight junctions and instead allows them to maintain an intestinal barrier, though it does not alter levels of zonulin.

In a rat study published in the Proceedings of the National Academies of Science, animals treated with the company's investigational drug did not develop Type I diabetes and didn't show any appreciable increase in intestinal permeability, despite serum zonulin levels that were comparable to those detected in untreated animals. Untreated animals that developed Type I diabetes showed an increase in intestinal permeability that was statistically significant starting from 44 days of age that was temporally coincident with increased serum zonulin. Also, in the untreated rats that developed Type I diabetes, serum glucose levels increased starting two weeks after the onset of zonulin-dependent increased permeability, while no significant changes in serum glucose levels were detected in non-Type I diabetes, drug-treated animals.

All such efforts have been internally driven to date at the seven-employee company, and the Series A funding is projected to carry that development through Phase II in the first half of 2007.

Alba's most advanced agonist compound is AT-1002, and it has been the subject of feasibility studies with potential pharmaceutical partners. "We are in negotiations and talks about working with other undisclosed companies to develop that technology further," Jeffers said. "We anticipate starting substantive license discussions with a number of parties, probably within the next three to four months."

A pair of San Francisco investors, SV Life Sciences and Alta Partners, led the Series A round, which also included HealthCap Venture Capital in Stockholm, Sweden; Red Abbey Venture Partners in Baltimore; and the Maryland Venture Fund, a state government investment vehicle. Additional participants were existing investors from bridge and angel rounds that netted $2 million over the past year, including Esperance BioVentures, a fund created by the founders of Esperion Therapeutics Inc. in Ann Arbor, Mich.; Astellas Ventures in Japan; Maryland TEDCO, another state government investment vehicle; and Townsend Capital in Baltimore.

In conjunction with the new financing, Alba built its board to include SV's Lutz Giebel, Alta's Dan Janney, HealthCap's Magnus Persson, Esperance's Roger Newton and Paterson.

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