Spero Therapeutics, Inc., a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant (MDR) bacterial infections and rare diseases, announced today that the Biomedical Advanced Research and Development Authority (BARDA) has exercised its first contract option for additional committed funding pursuant to its existing contract with Spero. Specifically, the option exercise provides Spero with $15.9 million in reimbursement for the further development of tebipenem HBr. Spero’s lead product candidate, tebipenem HBr, is an oral carbapenem currently being evaluated in a pivotal Phase 3 clinical trial for the treatment of complicated urinary tract infections (cUTI), with top-line data expected in the third quarter of 2020.
The option was exercised under Spero’s existing 2018 contract with BARDA, which provides for reimbursement to Spero of up to $46.8 million for qualified expenses for tebipenem HBr development over a five-year period. Total committed funding under the BARDA award to date is $34.0 million, inclusive of this first contract option being exercised. There is a second option exercisable by BARDA for the remaining $12.7 million of funding, subject to specified milestones being achieved under the award agreement. Furthermore, the Defense Threat Reduction Agency (DTRA) provides up to $10.0 million, in addition to the total potential award from BARDA, to cover the cost of the nonclinical biodefense aspects of the collaboration program for tebipenem HBr. Together, the two agencies will provide up to $56.8 million in total funding for the clinical development and biodefense assessment of tebipenem HBr, a portion of which is subject to the exercise of options by BARDA and Spero’s achievement of specified milestones.
The $15.9 million contract option exercise announced today is expected to support the funding of specified manufacturing activities required for approval of tebipenem HBr, including API validation batch manufacturing and stability studies. Additionally, the option is expected to support the funding of several non-clinical and clinical development activities relating to tebipenem HBr, including a Phase 1 bronchoalveolar lavage (BAL) study in healthy subjects to assess lung exposure of tebipenem HBr, an important assessment to support a biodefense indication as well as evaluation in lung infections. Tebipenem HBr has demonstrated preclinical activity in murine lung models of Gram-negative bacterial infections and its active pharmaceutical ingredient is also currently approved in Japan for the treatment of pediatric pneumonia. As a result of this option exercise, and together with support from DTRA, Spero intends to progress tebipenem HBr into non-human primate efficacy studies in one or more models of biothreat disease. Spero anticipates initiating a Phase 1 BAL clinical trial of tebipenem HBr in healthy subjects in the third quarter of 2020.
“We look forward to our continued relationship with BARDA and DTRA and appreciate their support as we work to advance tebipenem HBr to treat the serious unmet need of multi-drug resistant infections,” said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. “The tebipenem HBr Phase 1 BAL study will be important to our long-term strategy as we look towards new indications, including pneumonia, and to position tebipenem HBr as an effective medicine for biodefense applications.”
Tebipenem HBr Research Support
This project has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201800015C.
About Tebipenem HBr
Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is Spero’s novel investigational oral formulation of tebipenem, a carbapenem-class antibiotic marketed by Meiji Seika Pharma Co. Ltd. (Meiji) in Japan as Orapenem® since 2009 for pediatric infections limited to pneumonia, otitis media and sinusitis. Carbapenems are an important class of antibiotics because they have been observed to be safe and effective against drug-resistant Gram-negative bacterial infections. Spero is conducting a pivotal Phase 3 clinical trial of tebipenem HBr entitled ADAPT-PO (a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety and pharmacokinetics of orally administered tebipenem pivoxil hydrobromide compared to intravenous ertapenem in patients with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP)). Spero expects to report top-line data from the Phase 3 clinical trial in the third quarter of 2020. Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of cUTI.
About Spero
Spero Therapeutics, Inc. is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections and rare diseases.
Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is designed to be the first oral carbapenem-class antibiotic for use in adults to treat MDR Gram-negative infections.
Spero is also advancing SPR720, its novel oral therapy product candidate designed for the treatment of rare, orphan disease caused by pulmonary non-tuberculous mycobacterial (NTM) infections.
Spero also has a platform technology known as its Potentiator Platform that it believes will enable it to develop drugs that will expand the spectrum and potency of existing antibiotics, including formerly inactive antibiotics, against Gram-negative bacteria. Spero’s potentiator product candidate, SPR206, is designed to treat MDR Gram-negative infections in the hospital setting.
For more information, visit https://sperotherapeutics.com.
About BARDA
The Biomedical Advanced Research and Development Authority (BARDA), an agency within the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threats, pandemic influenza and emerging infectious diseases. For more information, visit https://www.phe.gov/about/barda/.
About DTRA
The Defense Threat Reduction Agency (DTRA), an agency within the United States Department of Defense (DoD), is the official Combat Support Agency for countering weapons of mass destruction (chemical, biological, radiological, nuclear, and high explosives). DTRA’s mission is to enable the DoD and the U.S. Government to prepare for and combat weapons of mass destruction, and has the responsibility to manage and integrate the DoD chemical and biological defense science and technology programs. DTRA’s continued effort to enhance the combat support mission also advances public health services by developing innovative technologies that protect against biological threats. For more information, visit http://www.dtra.mil/.
