BREAKTHROUGHS BLOG

April 10, 2016

Research Roundup: legislation to expedite antibiotic R&D, a graduated approach to drug patents, and more

Senior Program Assistant
GHTC
Staphylococcus aureus (MRSA) bacteria
Staphylococcus aureus (MRSA) bacteria. Photo: National Institute of Allergy and Infectious Diseases (NIAID).

Until very recently, no new class of antibiotics had been discovered in nearly 30 years. However, as antimicrobial resistance spreads, there is an urgent need for new antibiotics, particularly those that can treat infections resistant to existing drugs. In article in Health Affairs, Allan Coukell, senior director for health programs at the Pew Charitable Trusts, is calling on Congress to pass the Promise for Antibiotics and Therapeutics for Health (PATH) Act, which would permit the US Food and Drug Administration (FDA) to approve new antibiotics for use in limited patient populations with modified clinical trial requirements that would be determined by the agency itself. There is little financial incentive for antibiotic R&D as they are prescribed for short periods of time and as there is much competition among antibiotics. Conducting clinical trials, particularly for drug-resistant infections, is challenging: not only are these infections rare, but many patients are disqualified from participation due to compromised immune systems or pre-existing conditions. Additionally, the dearth of rapid tests results in many patients starting antibiotic regimens before being diagnosed with a drug-resistant infection. The PATH Act has passed the Senate Health, Education, Labor and Pensions Committee and was included in the 21st Century Cures Act, which passed the House of Representatives last year.

Pharmaceutical company GlaxoSmithKline (GSK) announced that it will not file patents for its products in least developed and low-income countries, enabling manufacturers to produce and distribute generic versions of their medicines in 50 countries with a combined population of nearly 1 billion people. In lower middle income countries, GSK will continue to file patents but will offer ten-year licenses to generic manufacturers for a small royalty. GSK is also exploring innovative ways to increase access to its new and future cancer drugs through voluntary licensing via the Medicines Patent Pool, a United Nations–backed initiative that partners with patent holders and generic manufacturers to facilitate access to medicines. The Pool was founded in 2010, exclusively for HIV/AIDS drug patents, but has since been expanded to include tuberculosis and hepatitis C.

The HIV virus mutates rapidly, and thus, standard approaches to vaccine development have not been successful. Rather, researchers have been testing and adapting antibodies—proteins targeting a specific pathogen—from patients, searching for the rare broadly neutralizing antibodies which are effective against manifold strains of the virus. Scientists at The Scripps Research Institute (TSRI) have now characterized the first “teenage” broadly neutralizing antibody, an immature version of the molecule, not yet effective against the HIV virus. The molecule was discovered by the Chinese Center for Disease Control and Prevention (China CDC). The team at China CDC collected blood samples from hundreds of HIV-positive patients, identifying those with the most effective anti-HIV antibodies. The patients were then monitored for five years, enabling the researchers to observe antibody development. Previously, scientists believed that broadly neutralizing antibodies matured over 10–15 years, however, from its teenage stage, this potent antibody developed rapidly in just 2 years. The researchers hope this discovery could inform HIV vaccine research and development by providing insight into how to prompt the human immune system to rapidly produce effective broadly neutralizing antibodies.

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