Unveiling plea CT Results Globally

VRL congratulate its team and all stakeholders for the successful presentation of results of plea Clinical Trial studies for its flagship product ELORES at IDWeek™ 2018, in San Francisco. The plea trial is India's first clinical trial of such design and VRL is proud to be the first Indian company to have conducted this study and present the results at the world's largest infectious diseases event, IDWeek 2018. We believe that this will further nourish the Indian research ecosystem and help in putting Indian innovations on the global research landscape.

Elores is a novel combination of Ceftriaxone (third generation beta-lactam cephalosporin), Sulbactam (beta-lactamase inhibitor) and Disodium EDTA (Class 1 Antibiotic Resistance Breaker). It enhances and restores the in vitro activity of Ceftriaxone against ESBL/MBL producing gram-negative bacteria, including enzyme families that belong to Ambler class A (TEM, SHV, CTX-M), class B (NDM, VIM, IMP), class C (some variants of AmpC), and class D (OXA ESBLs).

The plea Clinical trial was a multicenter, randomized, double-blind Phase 3 trial designed to evaluate the safety and efficacy of ELORES (Ceftriaxone+ Sulbactam+ EDTA) for the treatment of complicated Urinary Tract Infections (cUTI) including Acute Pyelonephritis (AP) versus Meropenem. The results of the plea Clinical Trial studies include analysis of the primary outcomes which are according to FDA & EMA guidelines (defined as clinical cure plus microbiologic eradication at the test-of-cure visit) based upon molecular strain typing of beta – Lactamase (ESBL and MBL) producing Gram Negative bacterial pathogens in both treatment arms.

The plea trial is India's first clinical trial of such design and VRL is proud to be the first Indian company to have conducted this study and present the results at the world's largest infectious diseases event, IDWeek. We believe that this will further India's research ecosystem and help in putting Indian research on the global research landscape.

The title and description of each poster and presentation times are noted below.