Allena begins Phase IIb trial of ALLN-177 to treat secondary hyperoxaluria

The randomized, crossover study Phase IIb trial is designed to evaluate the safety, tolerability and efficacy of three different doses of ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria.

The company said that ALLN-177 degrades oxalate in the gastrointestinal tract in an effort to reduce the burden of both dietary and endogenously produced oxalate.

It also has the potential to decrease the oxalate available systemically for deposition as calcium oxalate crystals or stones in the kidneys, as well as reduce the incidence of calcium oxalate related complications.

In conjunction with advancing its lead program into Phase IIb trials, the company has also expanded its leadership team with the appointment of Annamaria Kausz as vice president of clinical development.

Allena Pharmaceuticals chief operating officer Louis Brenner said: "Allena has made significant recent progress with the advancement of our ALLN-177 clinical program and with the addition of Dr Annamaria Kausz to our management team.

"Our Phase I and Phase IIa study results highlight the potential of ALLN-177 to help patients with oxalate disorders, and we are fortunate to secure Annamaria’s leadership for our clinical development organization."

Earlier trials, including a Phase I trial in healthy volunteers and a Phase IIa trial in patients with secondary hyperoxaluria, have showed proof-of-concept for the reduction of urinary oxalate excretion using ALLN-177.

As the company’s vice-president of clinical development, Dr Kausz, an adult and pediatric nephrologist, brings nearly a decade of industry experience in pharmaceutical clinical development and regulatory strategy.

Dr Kausz joins the company from EMD-Serono, where she led the development of early-stage immunology compounds.