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.
Trius Therapeutics Inc. intends to create drugs that are capable of combating resistant bacteria and are meaningfully differentiated from currently marketed products. It says its lead candidate will be "a true second-generation" version of linezolid (Zyvox), as yet the sole marketed compound in the class of drugs known as oxazolidinones. Linezolid's proven ability to combat Gram-positive bacteria such as MRSA and Streptococcus has made it a blockbuster on track to generate $1 billion in revenues this year. If Trius can develop an antibiotic that is safer and more effective than Zyvox, and that also possesses additional attributes that improve on the original drug, that new compound could commandeer significant market share.
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.