This blog was written by Ankit Mahadevia, CEO of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC.
Relative to a decade ago, those of us that have spent time finding new ways to outsmart drug-resistant bacteria have reason to feel optimistic about the current opportunities in our field.
We are addressing the awareness challenge that bacterial infections have had relative to other diseases. The problem of anti-microbial resistance is now regular, international news; frightening cases of pathogens resistant to every agent we have are making it into our consciousness. [Special mention to our colleagues at Reuters Health, @Statnews, and the @Timmermanreport who have gone into great depth on this issue] Policymakers around the globe have taken notice; this month’s UN General Assembly meeting aims to “summon and maintain strong national, regional and international political commitment in addressing antimicrobial resistance comprehensively and multi-sectorally, and to increase and improve awareness of antimicrobial resistance.” It’s only the fourth time in history that the General Assembly has gathered to talk about a health crisis.
In addition, our path to market has never been more collaborative. New regulatory approaches have found, in our opinion, a strong balance between getting much-needed agents to patients suffering from resistant infections and ensuring that they will do the job safely and efficaciously. The high fidelity of preclinical PK/PD analysis to translate to clinical efficacy certainly helps this virtuous cycle. The net result of this has been a resurgence of fresh approaches to resistant bacteria, especially in the biotech sector. By our count, over two dozen companies have sprung up since the passage of the GAIN Act in 2012 and many of those [examples here and here] have raised meaningful capital to advance their therapies. Indeed, Spero could not have started, grown, or financed itself without the changes that created this new environment.
This is the good news (and there’s a lot of it). That all said, there is more work to do (as always). The commercial model is robust for differentiated antibacterials that treat pathogens not addressed by available therapies; biotechs have and will advance and create meaningful value for these agents (some examples here and here).
That said, on a relative basis, the economic playing field is not level across therapeutic areas. Ezekiel Emanuel and others have very eloquently pointed out that antibiotics are not valued the same as other therapeutic areas by our health care system. We will routinely pay $10,000 for knee replacement but until recently we’ve balked at doing the same for lifesaving antibiotics. This calculus understandably drove many large players out of antibacterial research. A healthy ecosystem where biotechs, academic labs, regulators, policymakers, and Pharma work together to advance new drugs treating infection is crucial; any exits from the ecosystem make our job harder.
The silver lining is that policy makers in the US and EU have recognized the public health impact of these skewed incentives, and gotten some very thoughtful solutions tantalizingly close to the finish line. Last weeks news of over $285M in support from BARDA to support R & D efforts of Roche and the Medicines Company is a great signpost of the commitment to a robust ecosystem, and there is more to come. The 21st Century Cures package currently in the House has several proposals that address the issue. One in particular is DISARM, which would offer additional economic incentives through Medicare for antibiotics treating unmet need. Actually, the quantity of good solutions is not our issue. Our colleagues at the AMR Review note that there are over 50 public policy proposals that have received serious consideration for this issue. It is now time to choose those that have the best chance of getting passed and implemented. Spero and its SAB has been an active part of advancing this cause, participating in the international dialogue on bolstering the ecosystem through DRIVE-AB and the national dialogue through the President’s Advisory Council on the issue.
Great drugs do not need policy solutions to get to market and be successful whether in antibacterials or otherwise. However, great ecosystems do need healthy incentives to perpetuate. We at Spero support the implementation of a package of incentives that solidifies the momentum we have in the field by continuing to increase parity between therapeutic areas. This is the key to getting even more institutions to follow Roche, Merck, and Pfizer that have made meaningful investments in the field recently to create a more robust ecosystem. We at Spero and others in our sector are advancing in combating this problem; we’re keen to see more, and a more diverse set of, institutions rise to the challenge of antimicrobial resistance. Let’s choose a set of solutions to help them get there and move forward.