Merck’s Relebactam Met Primary Endpoints in Phase 3 Study

Merck’s (MRK) Relebactam is an investigational beta-lactamase inhibitor for the treatment of certain forms of imipenem-non-susceptible bacterial infections.

On April 22, 2018, Merck announced that the company presented the results of RESTORE-IMI 1 study at the 28th European Congress of Clinical Microbiology and Infectious Diseases (or ECCMID) in Spain.

Relebactam is an investigational drug from Merck’s portfolio. It is an intravenous class A and C beta-lactamase inhibitor being evaluated in combination with Imipenem/Cilastatin for the treatment of patients with complicated gram-negative bacterial infections.

The US Food & Drug Administration (or FDA) has granted “Fast Track” designation to the combination for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, complicated urinary-tract infections, and complicated intra-abdominal infections. Merck now plans to submit a new drug application for the fixed-dose combination of Relebactam with Imipenem/Cilastatin.

The RESTORE-IMI 1 study is a multicenter, double-blind, randomized, comparator-controlled study comparing the safety and efficacy of the use of Relebactam in combination with Imipenem/Cilastatin as compared to Colistin in combination with Imipenem/Cilastatin for the treatment of patients with imipenem-non-susceptible bacterial infections.

The study involved 47 patients, and 31 patients met the microbiological modified intent-to-treat (or mMITT) criteria. The RESTORE-IMI 1 study met its primary endpoints, and the drug Relebactam in combination with Imipenem/Cilastatin showed a favorable overall response in the mMITT population.

Merck is also conducting a RESTORE-IMI 2 study, a second phase three pivotal study evaluating Relebactam with imipenem/cilastatin as a fixed-dose combination, and compares the combination with piperacillin/tazobactam for the treatment of patients with hospital-acquired bacterial pneumonia.

The iShares US Pharmaceuticals ETF (IHE) holds 8.1% of its total investments in Merck (MRK), 8.8% in Pfizer (PFE), 10.2% in Johnson & Johnson (JNJ), and 6.0% in Eli Lilly (LLY).

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