uploads///dna _

Merck’s Relebactam Met Primary Endpoints in Phase 3 Study

Mike Benson - Author

Nov. 20 2020, Updated 12:01 p.m. ET

Merck’s Relebactam

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.

Article continues below advertisement

About Relebactam

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.

Other studies evaluating Relebactam

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).

Check out all the data we have added to our quote pages. Now you can get a valuation snapshot, earnings and revenue estimates, and historical data as well as dividend info. Take a look!


Latest iShares US Pharmaceuticals News and Updates

    © Copyright 2022 Market Realist. Market Realist is a registered trademark. All Rights Reserved. People may receive compensation for some links to products and services on this website. Offers may be subject to change without notice.