Allecra Therapeutics released positive top-line data from its Phase II trial of AAI101, an antibiotic against gram-negative bacteria.
Based in Lorrach, Germany and Saint Louis, France, Allecra Therapeutics released positive top-line data from its Phase II trial of AAI101, an antibiotic against gram-negative bacteria.
AAI101 is an extended spectrum beta-lactamase inhibitor. The Phase II CACTUS trial evaluated the antibiotic in hospitalized adults with complicated urinary tract infections (cUTIs). The study was to determine the optimal dose of cefepime/AAI101 that could be used in future Phase III trials. It evaluated two doses in the patients that had cUTI, as well as acute pyelonephritis (AP). The secondary objectives were evaluations of the safety and tolerability of the cefepime/AAI101 combination therapy, as well as early evaluations of the drug’s efficacy.
Cefepime is a fourth-generation cephalosporin antibiotic with an extended spectrum of activity against both gram-positive and gram-negative bacteria.
There were two cohorts, splitting 45 patients, each with a separate control. The first cohort received either 500mg of AAI101 with 1g of cefepime, or 1g of cefepime monotherapy. The second cohort received 750mg of AAI101 with 2g cefepime or 2g of cefepime monotherapy. The patients received intranveous doses three times a day for seven to 10 days.
Of the patients receiving the combination, 83 percent had complete microbiological eradication compared to 73 percent of those just receiving cefepime. Of the combo, 97 percent were determined to be clinically cured, compared to 93 percent of the cefepime monotherapy group. The company also found that 100 percent of Gram-negative bacteria isolated in the patients in the study were susceptible to the combination compared to 67 percent in the cefepime monotherapy and 83 percent susceptible to an alternate combination, piperacillin/tazobactam.
“These compelling results strongly suggest that cefepime/AAI101 has broad and potent actdivity against Gram-negative bacteria, including those expressing ESBLs, the most common resistance mechanism to beta-lactam antibiotics seen in hospitals,” said Yehuda Carmeli, head of the Israeli National Institute for Antibiotic Resistance and Infection Control at Tel-Aviv Medical Center, and a scientific advisor to the company. “I believe cefepime/AAI101 promises a major advancement in the ongoing fight against serious and difficult-to-treat hospital-acquired bacterial infections.”
The U.S. Food and Drug Administration (FDA) (FDA) granted cefepime/AAI101 Fast Track designation in November 2017 for the treatment of cUTI, complicated Intra-abdominal infections (cIAI) and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP). The agency also granted the compound Qualified Infectious Disease Product (QIDP) status.
A private company, Allecra also announced in November 2017 that it had raised an additional 9 million euros. The round was led by new investor, Xeraya Capital with participation from new investor BioMedPartners.
The proceeds will be used to pay for its AAI101 development and clinical trials.
“Allecra is focused to combat serious Gram-negative antibacterial resistance, one of the most widespread and fastest-growing public health concerns of this decade,” said Jason Rushton, partner at Xeraya Capital and an Allecra board member, in a statement at the time. “Allecra’s lead product is a compelling approach to address the problem and the company continues to benefit from considerable support from its current investors, external experts and key regulatory agencies.”
BioMedPartners’ Thomas Moeller also joined the company’s board of directors at that time as an observer.
