A "broken" investment model means a new antibiotic may not reach the market for another decade, according to the head of a $1 billion Big Pharma-backed fund focused on the growing threat of drug-resistant bacteria.
Urgent market reform is needed to encourage investment and expand the razor-thin pipeline of antibiotics in development, AMR Action Fund CEO Henry Skinner, Ph.D., told Fierce Biotech in an interview. The fund was set up by a who's who of leading biopharma companies with a mission of bringing up to four new antibiotics to patients by 2030, but even this ambitious goal is just "buying some time," Skinner said.
More than 1.2 million people worldwide die each year from infections caused by bacterial resistance, with the annual death toll set to rise to 10 million by 2050 unless new options are developed. However, companies and investors aren’t scrambling to assemble a robust antibiotic pipeline—they’re actually moving away from it, according to a February report from BIO.
With Big Pharma vacating the space, small biotechs face an uphill battle to fund and conduct new clinical trials, the trade association said. As a result, there are only 64 new antibacterial therapeutics currently in the clinical pipeline, of which 80% are being developed by smaller companies.
It’s not the industry’s fault, though, Skinner said. There’s simply not enough leverage for innovation to address the growing need.
“Industry goes where capital flows, and the market is broken for antibiotics,” Skinner said. Cancer drugs, with the promise of lucrative payments, can easily distract investors from the less glamorous world of antibiotics, which have limited market potential if valued only by volume, he added.
In fact, venture capital funding for U.S. antibiotic development over the last decade totaled just $1.6 billion, compared to $26.5 billion for oncology, according to BIO.
The power of policymakers
The societal value of antibiotics has to shift, Skinner said, noting these therapies form the foundation for current medical care.
So, how does marketplace reform occur? Skinner’s answer is simple: policymakers.
There must be incentives for successful drug innovation and development, according to the AMR Action Fund CEO, who previously held leadership roles at Tekla Capital Management, Novartis Venture Fund, NeoGenesis Pharmaceuticals and antibiotic-focused biotech SelectX Pharmaceuticals. Skinner pointed to the U.K., where the National Health Service is piloting a subscription payment model with Pfizer and Shionogi that guarantees a fixed fee for new antibiotics depending on importance and innovation, as an effort that is needed on a global scale.
A similar proposal in the U.S.—the Pioneering Antimicrobial Subscriptions to End Up surging Resistance (PASTEUR) Act—would also create a subscription model, encouraging innovative drug development targeting the most threatening infections and ensuring domestic availability of much-needed new therapies.
“We can’t fix the problem. All we can do is keep the pipeline going,” Skinner said of the AMR Action Fund's efforts. “We really need policymakers to enact these changes to bring a sustainable ecosystem back.”
Selecting the best targets
Set up in July 2020 by 20 leading biopharma companies including GlaxoSmithKline, Johnson & Johnson and Merck & Co. in collaboration with the World Health Organization (WHO), the European Investment Bank and the Wellcome Trust, the AMR Action Fund announced the first beneficiaries of its $1 billion stockpile last week: Adaptive Phage Therapeutics and Venatorx Pharmaceuticals.
The AMR Action Fund heavily weighs diligence when evaluating potential investments, zeroing in on companies that have immediate funding needs and are further along in the clinical process. Both Adaptive Phage and Venatorx were selected because each present a multitude of opportunities across the pipeline, Skinner said.
Adaptive Phage has several treatments in phase 1/2 development for prosthetic joint infection, recurring urinary tract infection and others, while Venatorx announced last month that its antibiotic cefepime-taniborbactam achieved the primary goal in a phase 3 study.
Venatorx is expected to file for FDA approval in patients with UTIs by the end of the year, but a specific strategy for promoting the drug has yet to be formulated. With the necessary data becoming available last month, the company is currently determining the best marketing approach for commercial success, Skinner said.
The two are great companies, he added, while suggesting that other biotechs equally deserving of funding are still out there.
The fund's primary goal of bringing two to four antibiotics to market this decade means it's laser-focused on the antimicrobial space, specifically addressing pathogens prioritized by the Centers for Disease Control and Prevention and the WHO. But Skinner hinted at the possibility of widening this scope to look at antifungals and diagnostics further down the line.
For the time being, the fund is set to keep adding to its portfolio of companies, with more investments likely this year, he said. It expects to hand out about $100 million in capital in 2022, although Skinner didn’t reveal how much of this is earmarked for Adaptive Phage and Venatorx.
Companies like these show there’s an enormous amount of innovation and promise occurring in the antibiotics space, said Skinner. It makes the case for marketplace reform more urgent than ever, “so scientists can be let loose to do what they do best.”