Start-Up's monthly comprehensive review of emerging life science companies that have received venture funding during the month, including companies in the pharmaceutical, medical device, diagnostic and research instrumentation and reagent sectors.

Antibiotic R&D has always been one of the most challenging areas in biopharmaceutical drug development. Designing novel drugs that deter bacterial resistance is a technical hurdle to be sure, but it's also a commercial one: drugs doomed to rapid obsolescence don't promise a strong return on investment. There are regulatory uncertainties, too. Although FDA is now asking drug sponsors to compare the effectiveness of products against a placebo or marketed drug for some indications--for the most part, certain infections in the primary care setting--non-inferiority studies remain the norm for life-threatening infectious diseases. But the agency has yet to issue hard and fast rules on where to apply these studies and how to evaluate the use of non-inferiority margins. A recent meeting of FDA's Anti-Infective Drugs Advisory Committee provided some clarity.

Indel Therapeutics Inc. is taking advantage of the differences in highly conserved protein regions to develop anti-infective drugs that won't succumb to resistance. The company is targeting essential proteins found in bacteria and in humans that are critical to the organism's survival. This makes the proteins attractive targets for drug developers, but there's a downside: a drug designed to inhibit proteins highly conserved in humans is likely to be toxic to the patient. Indel thinks it may have found a way around that problem. Its early-stage drug candidates target a number of these vital proteins by focusing insertion or deletion regions away from the protein's active site. In early studies, the start-up's therapeutics show promise at inhibiting a wide range of microbes including, bacteria, fungi, and parasites, while having no effect on human cells.

A preview of the emerging health care companies profiled in the current issue of Start-Up. This month's profile group, "Antibiotics Start-Ups," features profiles of Indel Therapeutics, MicuRx Pharmaceuticals and Trius Therapeutics. Plus these Start-Ups Across Health Care: DFine, NexeonMedSystems, SmartCells and Somnus Therapeutics.