Antibacterial Drug Development
This article was originally published in Start Up
For some start-ups, keeping pace with Big Pharma's shifting business priorities means following a path of less resistance. New companies are being formed around Big Pharma assets that no longer fit their priorities and market needs; others are fueled by novel discovery approaches based on elucidating and harnessing the power of natural genetic mechanisms.
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Despite the global increase in resistant bacterial infections, investment in development of new antibiotics and antimicrobials has declined over the past few years. Siena-based Molteni Therapeutics is taking a new look at antibacterials and antifungals, creating small-molecule photosensitizers activated by visible red light that destroy fungal and bacterial cells, in an approach known as antimicrobial photodynamic therapy.
Like numerous other companies working to develop novel anti-bacterial drugs, MicuRx Pharmaceuticals Inc. aims to modify existing chemical scaffolds to come up with better compounds. The start-up is particularly interested in four scaffolds known to inhibit protein synthesis-a common mechanism of action for anti-bacterial drugs. While the company's CEO and CSO-both of whom were among the scientific founders of Vicuron Pharmaceuticals--can offer much from their personal experience, MicuRx is carefully mining medical literature for insights and observations that can inform specific modifications to drug molecules.
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.