Spero Gets Grant of $54M for Biodefense R&D for SPR994

Spero Therapeutics granted $15.7 million for research on SPR994, its oral carbapenem-class candidate, to study the drug’s efficacy against biological threats like anthrax, plague and melioidosis as a part of an interagency collaboration.
The funds' provider, Biomedical Advanced Research and Development Authority, promised an additional grant of $28.5 million over five years to support the antibiotic developer’s clinical development of SPR994 in complicated urinary tract infections caused by drug-resistant bacteria. Moreover, the Defence Threat Reduction Agency promised a preliminary $1.25 million to fund the nonclinical aspects of the project, with up to $8.75 million in milestone payments.
The Cambridge, Massachusetts based Spero revealed in a statement that federal agencies plan to provide a total of $54.2 million in funding for the clinical development and biodefense assessments of SPR994, subject to options by BARDA and other milestones.
Tebipenem, an active ingredient of SPR994, is currently approved in Japan for pediatric cases, marketed by Meiji Seika Pharma as Orapenem. This collaboration may also involve a clinical trial in pneumonia. Presently, Spero plans to call for a pre-phase 3 meeting with the FDA to initiate its trial in cUTIs before the end of 2018.
A placebo-controlled, ascending-dose phase 1 study was initiated by the company in healthy subjects in October 2017, which showed positive interim results this month. The data showed an encouraging safety, pharmacokinetic and pharmacodynamic profile at a 300 mg dose thrice a day. Concluding statistics is expected in the later part of this year.
The phase 3 trial will be a double-blind noninferiority trial of oral SPR994 compared to intravenous ertapenem, a carbapenem-class antibiotic usually given for cUTI.

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