By: Ankit Mahadevia
Today we are pleased to announce our collaboration with BARDA, DTRA and USAMRIID for the further development of our oral carbapenem product candidate SPR994.
What it means for patients
A significant unmet need exists for an oral broad-spectrum antimicrobial to keep patients with complicated Gram-negative infections out of the hospital or allow them to transition out of the hospital sooner. Drugs like SPR994 that are designed to address drug-resistant, Gram-negative bacteria, including extended-spectrum beta-lactamases (ESBLs), have the potential to reduce risks from secondary infections. Resistance to approved oral agents such as fluoroquinolones has risen to alarming levels; over 30% of patients who receive fluoroquinolones for Gram-negative infections in the hospital suffer from fluoroquinolone-resistant infections. Having an oral agent with the spectrum to address resistant gram-negative infections and multiple biodefense threats will fill an important gap. We believe the collaboration between BARDA/DTRA/USAMRIID and Spero further validates the promising potential of SPR994 to fill this medical need and the Spero team’s capability to bring it to the market.
This collaboration provides meaningful support for three major streams of work on behalf of patients: 1) activities supporting our pivotal Phase III trial and NDA for patients with complicated urinary tract infections (cUTI); 2) in vitro and in vivo studies exploring the potential of SPR994 against biodefense threats; and 3) clinical work in a lung infection indication to support both biodefense and pneumonic applications for SPR994 in the hospital and community setting.
What it means for Spero
Spero’s vision is to develop complementary clinical stage therapeutics where each has a significant potential to address patient needs where existing therapeutics are not sufficient. Non-dilutive financing has been critical to that vision. Since inception, our pipeline of product candidates has been awarded approximately $54.6 million in non-dilutive funding from the government (including today’s announcement), of which $25.5 million has been committed, with an additional $29.1 million in conditional commitments. In addition to the $44.2 million awarded from BARDA mentioned above, as part of the collaboration between BARDA and DTRA, DTRA will provide up to $10.0 million to cover the cost of certain nonclinical biodefense studies contemplated by the collaboration. The partnership with BARDA and DTRA in particular enables a broader assessment of SPR994’s utility across indications and the funding they provide us will defray in part the total R&D cost of the cUTI indication. The latter is important to ensure the success of SPR994 and Spero’s ability to develop innovative products. We will continue to advance our efforts to collaborate with our public, nonprofit, and industry partners as we all unite against emerging drug-resistant infections.
What it means for the antibiotic ecosystem
In our view, the job of biotech is to address the mismatch between what patients need and what our Pharma ecosystem can deliver. Successful development to address unmet need has yielded major advances across modalities (e.g. oligonucleotides) and disease areas (e.g. rare diseases). Given the major mismatch between the Pharma pipeline and the continued advance of bacterial resistance, the mantle for the development of therapies to treat drug-resistant infections has passed to biotech. It’s an important reason why we started Spero just 4 years ago.
BARDA’s antimicrobials program, in collaboration with other public and private partners, helps shift the return-on-investment equation, which encourages corporate participation to efficiently bring novel antibacterial therapies to patients suffering from resistant infections. BARDA has invested in 15 candidate antibacterials since 2010. This number increases to 48 if the calculation accounts for BARDA’s investments made via the CARB-X program. Without BARDA’s support, there would be fewer therapies available for patients suffering from resistant infections and even fewer options for our nation’s biodefense.
About BARDA, visit https://www.phe.gov/about/barda/
About DTRA, visit http://www.dtra.mil/
About USAMRIID, visit http://www.usamriid.army.mil/
About the Authors:
Ankit Mahadevia, M.D.
Chief Executive Officer of Spero Therapeutics