Spero nets $54M biodefense R&D contract for its lead antibiotic

Bacteria
Spero is currently planning to launch a phase 3 trial of SPR994 in cUTIs around the end of the year, following a meeting with the FDA. (Spero)

Antibiotic developer and former Fierce 15 winner Spero Therapeutics has received $15.7 million in federal research funding for its oral carbapenem-class candidate, SPR994, which will be the subject of an interagency collaboration to evaluate the drug’s effectiveness against biological threats, including anthrax, plague and melioidosis.

The money from the Biomedical Advanced Research and Development Authority includes provisions for up to an additional $28.5 million over five years, and will also support Spero’s clinical development of SPR994 in complicated urinary tract infections caused by drug-resistant bacteria.

Under the collaboration, a series of studies will be conducted by the Army’s Medical Research Institute of Infectious Diseases. In addition, the Defense Threat Reduction Agency committed to an initial $1.25 million to fund the project’s nonclinical aspects, with up to $8.75 million in milestone payments.

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In total, federal agencies will provide up to $54.2 million in funding for the clinical development and biodefense assessment of SPR994, subject to options by BARDA and other milestones, the Cambridge, Massachusetts-based Spero said in a statement.

The collaboration may also include a clinical trial in pneumonia. SPR994’s active ingredient, tebipenem, is currently approved in Japan for pediatric cases, marketed by Meiji Seika Pharma as Orapenem.

RELATED: Spero plans to have two antibiotics for resistant pathogens in pivotal trials next year

Currently, Spero plans to request a prephase 3 meeting with the FDA in the next few months, with the goal of initiating its trial in cUTIs around the end of the year.

The company launched a placebo-controlled, ascending-dose phase 1 study in healthy subjects in October 2017, and released positive interim results earlier this month. According to the company, data showed a favorable safety, pharmacokinetic and pharmacodynamic profile at a 300 mg dose three times per day. Final data is expected in the third quarter of this year.

“The rapid emergence of resistant organisms has created a major need for an oral treatment option that can effectively treat patients who are currently only candidates for IV therapy.” Spero CEO Ankit Mahadevia said at the time.

The company’s phase 3 trial will be designed as a double-blind noninferiority trial of oral SPR994 compared to intravenous ertapenem, a carbapenem-class antibiotic commonly prescribed for cUTI.

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