Amolyt Raises $80M to Develop AZP-3601 for Hypoparathyroidism

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by Patricia Inacio PhD |

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Amolyt Pharma has raised $80 million in financing that will support the clinical development of AZP-3601, its experimental therapy for hypoparathyroidism.

Hypoparathyroidism is caused by abnormally low levels of the parathyroid hormone (PTH), leading to low vitamin D and calcium levels, as well as high phosphorus levels in the blood.

Current therapies frequently fail to control calcium blood levels and to prevent excessive calcium loss in the urine, which increases the risk of chronic kidney disease.

AZP-3601 has a similar structure to PTH — called a PTH analog. It was designed to bind to a specific configuration of the PTH receptor, to sustain normal calcium levels in the blood and limit the amount of calcium eliminated in the urine. As a result, the therapy is thought to ease symptoms and prevent chronic kidney disease.

The therapy also has a short half-life (the time it takes for its circulating levels to drop by half), which reduces the risk of damage to bones due to prolonged exposure.

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The Series B financing was co-led by Sectoral Asset Management and Andera Partners, with the support of ATEM Capital and of previous investors LSP, Novo Holdings (Novo Ventures), Kurma Partners, Mass General Brigham Ventures, Innobio 2 managed by Bpifrance, Orbimed, Pontifax, Eurazeo, Sham Innovation Santé/Turenne Capital, and Credit Agricole Creation.

“We are very pleased to expand our high-quality syndicate with the addition of these new North American and European investors, and we are highly appreciative of the continued support from our existing investors,” Thierry Abribat, PhD, Amolyt’s founder and CEO, said in a press release.

The funding will also be used to advance the company’s pipeline for other rare endocrine (hormone-related) diseases, including acromegalya disorder characterized by too much growth hormone produced during adulthood.

“This financing will give us the opportunity to further pursue our mission of building a leading rare endocrine and related disease company, and we will continue to work to introduce new and potentially life-changing therapeutics to patients globally,” Abribat said.

The company will host a webinar about AZP-3601, scheduled for Oct. 1 at 10 am ET. To register, go here.

The key opinion leader webinar will feature a presentation by John P. Bilezikian, MD, PhD, a professor at Columbia University and chief, emeritus, of the university’s division of endocrinology. Bilezikian is an expert on parathyroid hormone and disorders related to the parathyroid glands.

Abribat will present a corporate update and an overview of Amolyt’s pipeline. Soraya Allas, MD, PhD, vice president of clinical development and regulatory affairs at Amolyt, will discuss the results from a Phase 1 trial testing the safety, tolerability, pharmacological properties, and preliminary efficacy of single and multiple increasing doses of AZP-3601 in healthy volunteers. The multiple ascending dose part of the trial was completed this month.

An interim analysis showed that a single dose of AZP-3601 led to a significant, sustained increase in blood calcium levels for at least 24 hours.

The trial’s results will be presented at the upcoming American Society for Bone and Mineral Research 2021 Annual Meeting, Oct. 1–4, in San Diego, California.