Beating out market leaders in PhII, antibiotic-maker Allecra readies for Phase III trials
European biotech Allecra announced good news from the frontlines of its fight against multidrug-resistant gram-negative bacteria – some of the most dangerous superbugs around – after wrapping up a Phase II study of its investigational antibiotic.
The company’s lead antibiotic candidate, an extended spectrum β-lactamase inhibitor known as AAI101, met all of the study’s objectives, prepping Allecra to take the drug into Phase III.
In the Phase II trial, AAI101 was given intravenously to patients in combination with a well-known antibiotic called cefepime for the treatment of hospitalized patients with complicated UTIs. The combo was found safe and well-tolerated and achieved high rates of microbiological eradication and clinical cure. Allecra said all tested pathogens were susceptible to their combo of cefepime and AAI101, including those not susceptible either to cefepime alone or to the market leader, piperacillin/tazobactam (marketed under the brand name Tazocin, among others).
Allecra, founded in 2013, has already raised a few rounds of cash to fuel its operations so far, including a recent tranched deal (the first stage of which was roughly $11 million) led by Xeraya Capital with some backing from BioMedPartners. That followed a $24.7 million Series B in 2016, and a $19.6 million launch round back in 2013.
“The results from Allecra’s Phase II Cactus study solidify Allecra’s plans to advance cefepime/AAI101 into Phase III later this year,” said Nicholas Benedict, co-founder and chief executive officer of Allecra in a statement.
Last November, cefepime/AAI101 was granted fast track designation by the FDA for the treatment of cUTI, complicated intra-abdominal infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. FDA has also granted cefepime/AAI101 qualified infectious disease product status.