Venatorx Pharmaceuticals Announces Positive Phase 1 Results for VNRX-7145

Venatorx Pharmaceuticals

MALVERN, PA —Venatorx Pharmaceuticals announced positive top-line results for its Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial (ClinicalTrials.gov – NCT04243863) of VNRX-7145, a novel component of the investigational oral antibiotic combination product. VNRX-7145, in combination with ceftibuten, a third-generation, orally-bioavailable cephalosporin antibiotic, is designed for the treatment of patients with infections caused by multi-drug resistant (MDR) gram-negative pathogens that are resistant to current standard-of-care oral and intravenous antibiotics, including fluoroquinolones, cephalosporins and carbapenems.

The Phase 1 study was a 2-part, first-in-human dose-ranging study to evaluate the safety and pharmacokinetics (PK) of escalating oral doses of VNRX-7145. In part 1, subjects received single ascending doses of VNRX-7145; in part 2, subjects received multiple escalating doses of VNRX-7145 for 10 days. There were no serious adverse events, and VNRX-7145 was well-tolerated up to the highest single or multiple doses administered. VNRX-7145 had excellent oral bioavailability, dose-proportional PK across the doses studied, and readily achieved efficacy exposure targets identified in non-clinical studies. Complete results from this study will be presented at an upcoming scientific meeting.

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With these positive topline results in hand, Venatorx is continuing the development of VNRX-7145 with a Phase 1 drug-drug interaction (DDI) study (ClinicalTrials.gov – NCT04877379), which will provide an initial assessment of the safety and PK of single and multiple doses of VNRX-7145 and ceftibuten, the selected beta-lactam partner, when co-administered. Top line results are expected in the fourth quarter 2021.

“There is an urgent need for oral antibiotics to combat resistant gram-negative pathogens. Currently, there are no approved orally-bioavailable beta-lactam or beta-lactam/beta-lactamase inhibitor combinations that cover Enterobacterales expressing key class A or D carbapenemases or class C cephalosporinases,” said Christopher J. Burns, Ph.D., President and CEO of Venatorx. “The increasing rate of infections caused by these organisms, and the resulting need for hospitalization for intravenous therapy, places a high toll on patient health and creates significant public health and economic burdens.”

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“Based on the initial human safety and PK data and the potent in vitro activity against MDR Enterobacterales, we believe that the combination of VNRX-7145 with ceftibuten represents a high-potential treatment option to address the needs of patients with infections caused by ESBL-producing organisms including the possibility of reducing hospitalizations,” said Tim Henkel, M.D., Ph.D., Chief Medical Officer at Venatorx. “We thank the investigators and subjects who have participated, and will participate, in this and future studies, as well as the National Institute of Allergy and Infectious Diseases, for their support. As we continue to progress our program through Phase 1, we look forward to meeting with the FDA to finalize the protocols for our Phase 3 clinical trial, which we expect to initiate in the second half of 2022.”

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