Anti-infective new drug combination phase 2 clinical results are positive

Anti-infective new drug combination phase 2 clinical results are positive

March 28, 2018 Source: WuXi PharmaTech

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Allecra Therapeutics recently announced that its antibiotics have a positive top-line result in a phase 2 clinical study of the combination of drug AAI101 and cefepime for the treatment of urinary tract infection (cUTI). Allecra Therapeutics is a biopharmaceutical company dedicated to the development of new antibiotics for the treatment of drug-resistant bacterial infections.

Antibiotic resistance is becoming one of the biggest health care challenges of the 21st century. It jeopardizes the lives of more and more patients and threatens many of our modern medical practices. Microbial resistance occurs because of the use of antibiotics. However, excessive use and abuse of human and animal antibiotics, poor infection control, and inadequate sanitation have accelerated microbial resistance. Every country is affected and an estimated 700,000 people die each year from microbial resistance. According to the Centers for Disease Control and Prevention (CDC), at least 2 million people in the United States each year have serious infections due to drug-resistant bacteria.

AAI101 is a novel extended-spectrum beta-lactamase inhibitor designed to overcome the resistance of typical Gram-negative hospital pathogens carrying extended-spectrum β-lactamases (ESBLs).

Cefepime is a fourth-generation cephalosporin antibiotic with broad activity against both Gram-positive and Gram-negative bacteria.

The Phase 2 CACTUS study of cefepime/AAI101 was a randomized, double-blind, multicenter study. Patients were divided into two groups of 45 patients each. The first group received 500 mg of AAI101 and 1 g of cefepime or 1 g of cefepime monotherapy. The second group received either 750 mg AAI101 and 2 g cefepime or 2 g cefepime monotherapy. The patient received an intravenous injection of three to ten days, three times a day.

Of the patients receiving combination therapy, 83% completely eliminated microbes, while 73% of patients receiving cefepime monotherapy were completely eliminated. Ninety-seven percent of patients receiving combination therapy were identified as clinically cured, compared with 93% receiving cefepime monotherapy. The company also found that 100% of Gram-negative bacteria in the patients participating in the study were sensitive to the combination, while the sensitivity of cefepime monotherapy was 67%.

In addition, cefepime/AAI101 is safe and well tolerated, and there is no clear association between AAI101 administration and treatment of emergency adverse events or laboratory abnormalities. These results provide strong evidence for the initiation of Phase 3 studies.

In November 2017, the US FDA awarded the Cefepime/AAI101 Fast Track designation for the treatment of cUTI, complex intra-abdominal infection (cIAI) and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia ( HABP / VABP).

"These convincing results strongly suggest that cefepime/AAI101 has broad and effective activity against Gram-negative bacteria, including those that express ESBLs, which is the most common beta-lactam antibiotic resistance in hospitals. Medication mechanism. I believe that cefepime/AAI101 is expected to make significant progress in combating this serious and difficult to treat hospital-acquired bacterial infection," Allecra Scientific Advisor, Israel National Institute of Antibiotic Resistance and Infection Control (Israeli National Institute) Dr. Yehuda Carmeli, Director of the Antibiotic Resistance and Infection Control, said.

â–² Mr. Nicholas Benedict, Co-founder and CEO of Allecra (Source: Allecra Therapeutics Official Website)

“The urgent unfinished medical needs have forced Allecra and some like-minded companies to develop solutions that address the prevalence of antibiotic resistance in hospitals. The results of the Phase 2 CACTUS study cemented Allecra's plan to bring cefepime/AAI101 later this year. Advancing to Phase 3 clinical," said Nicholas Benedict, co-founder and CEO of Allecra.

Reference materials:

[1] Allecra Therapeutics official website

[2] Allecra Therapeutics Announces Positive Top-Line Results from Phase 2 CACTUS Study of its Lead Candidate, AAI101, in Combination with Cefepime to treat complicated Urinary Tract Infections (cUTI)

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