Entasis Therapeutics has filed to raise up to $86 million through an IPO. The AstraZeneca spinout is seeking the money to fund a phase 3 trial of a drug to overcome bacterial resistance to beta-lactams.
Massachusetts-based Entasis spun out of AstraZeneca with an antibiotic drug discovery platform and funding in 2015. Since then, Entasis has raised $82 million from backers including Clarus Lifesciences, Novo Holdings and Frazier Life Sciences, enabling it to take its lead candidate to the cusp of phase 3.
The phase 3 will assess the effect of an intravenous fixed-dose combination of beta-lactam antibiotic sulbactam and Entasis’ experimental beta-lactamase inhibitor, ETX2514. Entasis aims to link ETX2514 to reduced 28-day all-cause mortality in patients infected with carbapenem-resistant Acinetobacter, thereby validating its belief the drug stops resistance by inhibiting class A, C and D beta-lactamases.
With the phase 3 trial due to start in the first quarter of next year, Entasis is seeking $86 million from public investors. The funding will see Entasis through to the delivery of data in 2020. Entasis plans to file for FDA approval on the strength of data from that single phase 3 trial.
The development strategy gives Entasis a shot at bringing ETX2514 to market in extremely unwell patients with Acinetobacter infections, before potentially expanding its use into other groups. Entasis is gathering data on ETX2514 on carbapenem-resistant Enterobacteriaceae and Pseudomonas in its Acinetobacter-focused clinical trials.
Entasis has a second program, gyrase-inhibitor zoliflodacin, that is also set to enter phase 3 next year. The Drugs for Neglected Diseases initiative is fully funding the gonorrhea trial, freeing Entasis to put the rest of its anticipated IPO haul into earlier-stage candidates.
A second beta-lactamase inhibitor, ETX0282, is in development as part of a combination treatment for complicated urinary tract infections. The trial has hit some early problems. In the single-ascending dose phase, four out of 36 subjects suffered mild-to-moderate vomiting. Entasis is now exploring ways to mitigate the effect, including modified-release formulations and administration with food.
The IPO is expected to give Entasis money to support early-phase work on ETX0282 and leave it with enough left to move a candidate from its non-beta-lactam inhibitors of the penicillin-binding proteins (NBP) program into the clinic. Entasis thinks NBPs are a new class of Gram-negative antibiotics.