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Entasis Therapeutics Holdings Inc. says primary endpoint met in late-stage trial for SUL-DUR in Acinetobacter infections.

Announcing topline results from a Phase 3 registrational trial for SUL-DUR, Entasis Therapeutics(NASDAQ:ETTX)says that the 207-patient study met the primary endpoint for patients withcarbapenem-resistantAcinetobacterinfections.

Entasis (ETTX) have added ~26.7%in the pre-market.

On the tolerability front, the two-part study reached the primary safety objective showing a decline in nephrotoxicity with statistical significance.

In the CRABC m-MITT population (n=125) of Part A of the study, 28-day all-cause mortality stood at 19.0% (12/63) compared to 32.3% (20/62) in the colistin arm, indicating the achievement of the primary endpoint with statistical non-inferiority versus colistin.

The clinical cure at Test of Cure (TOC) reached 61.9% in the SUL-DUR arm compared to 40.3% in the colistin arm showing statistical significance.

~88% of patients who received SUL-DUR experienced adverse events (AEs) versus ~94% and ~89% in the colistin arms Part A and B, respectively, showing a comparable safety profile for the experimental therapy.

“We look forward to discussing our data with the regulatory agencies and preparing our first regulatory submission in mid-2022,” CEO Manos Perros remarked.

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