New drugs for TB advance to clinic - C&EN Global Enterprise (ACS

TBA-7371 blocks an enzyme critical for synthesizing the polysaccharides that compose the TB bacteria's cell wall. Development of DprE1 inhibitors bega...
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GLOBAL HEALTH

New drugs for TB advance to clinic and the nonprofit continued to pursue the compound class. Sutezolid, meanwhile, has been around since the late 1990s. The compound is an analog of the approved antibiotic linezolid, but with fewer side effects and better potency. The trials are “definitely a step forward,” says Sean Ekins, who is CEO of Collaborations Pharmaceuticals and is on the advisory board of the TB-focused nonprofit MM4TB. Ekins points out that most combination treatments in clinical studies rely on drugs that were invented in the 1940s and ’50s. “The pipeline is so sparse that anything going into a clinical trial is huge.”

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TBA-7371

Indeed, just two other new TB drugs have been approved in recent years, and both—Johnson & Johnson’s bedaquiline and Otsuka Pharmaceutical’s delamanid— are intended only to treat multi-drug-resistant TB. Yet the need for new TB treatments is great. The World Health Organization estimates that 2 billion people are infected with the bacteria that cause TB and that the infection kills some 1.8 million people each year. The threat has become particularly worrisome for those with compromised immune systems; in 2015, 400,000 people coinfected with TB and HIV died.—LISA JARVIS

PHARMACEUTICALS

POLLUTION

China will accept foreign clinical trial data

Firms act on ocean plastic

In a move likely to benefit Chinese citizens as well as foreign drug firms, the Chinese government has agreed to accept data from clinical trials conducted outside China for the approval of new drugs. “Applicants can directly apply for drug listing registration after the completion of the international multicenter drug clinical trials,” the China Food & Drug Administration (CFDA) disclosed in a statement. Until now, China approved only drugs that had been tested on people in China. And foreign firms could start testing in China only after they had demonstrated the safety of their drugs with tests conducted overseas. This meant that Chinese people gained access to innovative new drugs years after they had been approved elsewhere—if ever. In the past, many major companies did not bother to launch their drugs in China because of the cost and delay involved. By the time foreign-developed drugs gained approval, competing versions were often already available from Chinese firms. CFDA has been reforming its drug registration process for several years. The agency has been hiring more reviewers to reduce its drug application backlog. It also warned companies registering drugs in China to withdraw their applications—or face administrative sanctions—if they suspected or knew that their clinical trial data had been falsified in order to obtain approval. The warning helped reduce the number of applications that the agency had to review. IMS Health, a market research firm, expects that China will account for 11% of global pharmaceutical spending by 2020. The country is already the world’s second-largest drug market after the U.S.—JEAN-FRANÇOIS TREMBLAY

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C&EN | CEN.ACS.ORG | OCTOBER 16, 2017

Two initiatives involving industry aim to stop ocean plastic pollution at the source. At the Our Ocean 2017 conference, held in Malta earlier this month, the Ocean Conservancy—in partnership with the Trash Free Seas Alliance, Closed Loop Partners, PepsiCo, 3M, Procter & Gamble, the World Plastics Council, and the American Chemistry Council—unveiled a plan to raise $150 million to fund waste management projects in Southeast Asia. The project aims at the root of the problem, the partners say. They say only five countries—China, Indonesia, the Philippines, Thailand, and Vietnam—are responsible for 8 million metric tons of ocean plastic pollution each year, half of the world’s total. The partners say the oceans today are contaminated by 150 million metric tons of plastic, a number that could rise to 250 million metric tons by 2025. Closed Loop Partners, an investor in recycling companies and technologies, will manage the fund. It plans to use the money to support municipalities, entrepreneurs, and nongovernmental organizations in their efforts to improve waste management systems. “Plastics play an important role in commerce,” said Jack McAneny, P&G’s director of sustainability. “But clearly they don’t belong in our waterways and oceans.” Also at the Our Ocean conference, the Austrian polyolefins maker Borealis announced its own plan to put $5 million towards a waste management project for Indonesia. Borealis said it will partner with municipalities to create “zero-leakage” pathways for garbage that increase recycling rates while creating jobs and public health benefits.—ALEX TULLO

Plastic trash litters the Manila shoreline.

CR E D I T: S KI P N A LL /AURO RA P H OTO S

Two new drugs for tuberculosis are being tested in humans, an important step in addressing the dearth of treatments for the deadly infection. The nonprofit TB Alliance says Phase I studies have started for both TBA-7371, part of a new class of antimicrobials called DprE1 inhibitors, and the oxazolidinone sutezolid. TBA-7371 blocks an enzyme critical for synthesizing the polysaccharides that compose the TB bacteria’s cell wall. Development of DprE1 inhibitors began as part of a research collaboration between TB Alliance and AstraZeneca. In 2014, AstraZeneca shut down the R&D site in Bangalore, India, where TB work was conducted,

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