Allecra Therapeutics’ candidate that blocks the development of antibiotic resistance has been awarded the FDA’s Fast Track Designation and will enter Phase III this summer.

Allecra Therapeutics, our biotech of the week a few weeks ago, develops new treatments for multidrug-resistant Gram-negative bacterial infections. The company has received Fast Track Designation from the FDA and will begin a Phase III trial for its lead candidate AAI101 in combination with the antibiotic cefepime. This represents a big boost to the antibiotics field, which is currently fighting the rapidly growing antibiotic resistance crisis.

With antibiotic resistance estimated to be responsible for 700,000 deaths each year, and predicted to overtake cancer in terms of mortality by 2050, the danger posed by ‘superbugs’ is clear. Allecra wants to combat this by blocking the mechanisms used by bacteria to develop resistance. AI101 manages this by blocking the hydrolysis of β-lactam, which could help to prevent urinary tract infections, intra-abdominal infections, and hospital-acquired bacterial pneumonia.

Many biotechs are trying to produce new antibiotics, including Motif Bio, whose candidate, iclaprim, succeeded in Phase III. However, perhaps due to the high costs and potentially low reward of developing new antibiotics, companies like Allecra and Da Volterra, with its medical device, are trying to protect the ones that we have already.


Image – Wanannc / shutterstock.com

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