Alizé Pharma 3 Rebrands as Amolyt Pharma, Plans AZP-3601 Trial

Alizé Pharma 3 is rebranding as Amolyt Pharma and plans to start clinical testing of a potential hypoparathyroidism treatment known as AZP-3601 later this year.

“Our new name, Amolyt Pharma, is derived from ammolite, a rare gemstone originating from living organisms,” Thierry Abribat, PhD, the company’s founder and CEO, said in a press release.

“Its spiral structure reflects the journey that we envision a patient, who is using our therapeutic peptides, will take from disease to recovery and to the return of a fully functioning life,” Abribat said. “Ultimately, the rebrand highlights our commitment to provide innovative treatments that safely and effectively restore balance.”

Amolyt specializes in the development of therapeutic peptides — engineered small proteins — as treatments for rare endocrine and metabolic diseases.

“We believe that we are well-equipped for upcoming milestones, starting with the planned initiation of a Phase 1 clinical trial for AZP-3601 during the second half of 2020,” Abribat added.

AZP-3601 will be tested as a treatment for hypoparathyroidism, which is characterized by low levels of the parathyroid hormone (PTH). Those lesser amounts, in turn, cause low calcium and high phosphate levels in the blood. Calcium and vitamin D supplements can be beneficial, but their low efficacy can lead to additional stress on the kidneys, due to the extra work that’s needed to excrete higher calcium amounts in the urine.

An alternative strategy for treating hypoparathyroidism is replacement therapy, which means providing human PTH to “replace” the missing hormone. However, human PTH does not stay in the blood for long periods and also shows lack of efficacy.

Originally developed by researchers at Massachusetts General Hospital and Harvard Medical School, AZP-3601 is an analog of PTH. An analog is a chemical compound that is structurally similar to another but differs slightly in its composition.

Designed as replacement therapy for hypoparathyroidism, AZP-3601 binds strongly to a specific configuration of the PTH1 receptor, which is expected to have a prolonged effect on calcium and vitamin D levels in the blood.

The therapy is intended to prevent chronic kidney disease and to preserve bone integrity. According to Amolyt, many patients with hypoparathyroidism are middle-aged women who often are at higher risk of osteoporosis. That makes AZP-3601’s benefits on bones particularly important.

AZP-3601 has outperformed natural PTH at increasing and maintaining calcium levels in preclinical studies, without causing additional kidney stress, according to Amolyt. The company expects such benefits to translate into greater safety and efficacy over other forms of replacement therapy for people with hypoparathyroidism.