Celebrating Success: Major Achievement in COMBACTE-CARE

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Good Recruitment Progress in REVISIT

Despite ongoing challenges that the pandemic is presenting, good progress is being made with enrollment in the ATM-AVI Phase 3 REVISIT study.

Site activation planning and sites’ ability to prioritize study activities are being heavily impacted, but of the 159 sites selected globally, 76 have now been activated for enrollment. Of these, 37 are within the COMBACTE region. A total of 68 subjects have been randomized globally, indicating that of those sites that are active and have current capacity to enroll, engagement with and activity on the study is high. Of note, sites 1133 (n=8) and 1135 (n=6) in Spain and 1143 (n=3) in Turkey have so far contributed the highest enrollment in the COMBACTE region – thank you!

Over the coming weeks, the team anticipate a bolus of sites will achieve activation and shortly thereafter there will be a boost to current enrollment figures.

The team continues to execute a number of site support initiatives, training, and ongoing feasibility/site selection in order to drive enrollment and minimize delays to the program.

The WP2B Management Team would like to acknowledge and express our gratitude for the hard work all site staff are conducting during these difficult times.

About REVISIT

Determining efficacy and safety of ATM-AVI for treating serious infections caused by Gram-negative, carbapenem-resistant, bacteria. REVISIT – Revisiting serious bacterial infection with innovation is conducting a Phase III randomized, open-label, comparative clinical trial to determine the efficacy and safety of aztreonam-avibactam (ATM-AVI). ATM-AVI is intended for treating serious bacterial infections caused by Gram-negative bacteria, including metallo-beta-lactamase-producing MDR pathogens, for which there are limited or no treatment options.

The phase II REJUVENATE project (WP2A) reported the PK and safety of ATM-AVI  in a representative patient population and confirmed the dose regime for Phase III program.  WP2B is a pivotal regulatory submission global phase III study (REVISIT) which will further establish the efficacy and safety of treating a representative population of serious Gram-negative bacterial infections with ATM-AVI. Pfizer, as sponsor, and COMBACTE-CARE via WP2B are conducting this study in co-development with AbbVie (formerly Allergen) and co-funded by the US Biomedical Advanced Research and Development Authority (BARDA).

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