Major layoffs underscore ongoing fight to develop new antibiotics

0

Antibiotic developer Spero Therapeutic recently laid off 75% of its employees after the US Food and Drug Administration failed to approve the company’s Phase 3 candidate to treat drug-resistant urinary tract infections (UTI). FDA action on June 27 completed a milestone the Cambridge, Massachusetts-based company had planned.

FDA approval would have made the drug available for patients with complicated UTIs, conditions for which one of the major unmet patient needs is the treatment options for available antibiotic-resistant strains. Spero is the latest in a string of small pharmaceutical companies that have struggled to stay afloat while trying to bring badly needed new antibiotics to market. This news comes at a time when bacteria are becoming increasingly resistant to available antibiotics, leading to more 1.2 million dead worldwide just in 2019.

As of December 2020, small companies like Spero, rather than the big pharma that once dominated this field, were researching and testing 95% of antibiotic products in development. Indeed, the market for these life-saving drugs is starkly different from that of most other pharmaceuticals, a reality that leads to unsustainable returns on investment.

As a result, most major corporations have abandoned antibiotic research and development to focus on efforts to bring more lucrative drugs to market in other disease areas. The few remaining small companies – mostly startups that have never brought a drug to market – are facing crippling financial difficulties, forcing many potentially life-saving antibiotics from further development before they reach the patients.

In 2019, for example, Achaogen and Melinta Therapeutics, which had recently received FDA approval for new antibiotics, filed for bankruptcy. That same year, Therapeutic Octagon Inc. put aside his promising antibiotic program and redirected all efforts towards a related approach to the treatment of autoimmune diseases. In 2020, Tetraphase was acquired for a small fraction of its valuation, although it marketed Xerava, an antibiotic that fights particularly stubborn abdominal infections. No other class of drugs has experienced economic difficulties on this scale.

This trend led to a nearly 40-year drought in the discovery of new types of antibiotics and today woefully insufficient pipeline. Reversing it will require substantial investment and economic incentives.

In recent years, encouraging steps have been taken. For example, the United States created in 2016 the Fighting Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global nonprofit partnership focused on strengthening the pipeline. CARB-X provides funding and support to small companies that have promising antibiotics in early development. In May, the partnership initiated up to $300 million more to continue this crucial work over the next decade. Moreover, in 2020, pharmaceutical companies have created the RAM Equity Fundwhich pledged $1 billion to support antibiotic innovation with the goal of bringing two to four new antibiotics to patients by 2030.

However, these types of investments are not enough on their own. Ultimately, policymakers must make systemic changes to how antibiotics are valued and how they are paid to respond adequately to the failing market. This can begin with Congress passing the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act. Much like a similar initiative in the UK, the PASTEUR Act would decouple revenue from sales volume and instead pay for access to much-needed antibiotics based on their public health value via subscription-style contracts. The bill would also increase resources for the development of urgently needed new antibiotics and provide support for antibiotic stewardship programs, which aim to keep antibiotics available for as long as possible.

The PASTEUR Act enjoys broad bipartisan support in both the U.S. House of Representatives and Senate, and in the Biden administration. 2023 fiscal year budget called for the kind of incentives included in the legislation. Passing the measure would be a major step towards fixing the broken antibiotics market and thwarting a further loss of companies’ expertise in antibiotic development.

Let’s not wait for other companies to suffer the same fate as those that came before us. Don’t wait for resistant infections to get worse. Congress should pass the PASTEUR law now. There’s no time to lose.

David Hyun, MD, directs The Pew Charitable Trusts Antibiotic Resistance Project.

Share.

About Author

Comments are closed.