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Spero Therapeutics Announces Exercise of $15.9 Million Option by BARDA for Tebipenem HBr Development
CAMBRIDGE, Mass., Feb. 05, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., Feb. 05, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), 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. \n 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) stud...