Amolyt Pharma to Present Preliminary Phase 1 Data on AZP-3601 for Hypoparathyroidism and Additional Preclinical Data on AZP-3404 at ENDO 2021

LYON, France, and Cambridge, MA, March 16, 2021 — Amolyt Pharma, a global company specializing in developing therapeutic peptides for rare endocrine and metabolic diseases,

today announced that it will be presenting four abstracts at the Endocrine Society’s Annual Meeting, ENDO 2021, being held virtually from March 20-23, 2021.

Amolyt will present preliminary data from its Phase 1 clinical trial evaluating AZP-3601, a parathyroid hormone analog specifically designed for the treatment of hypoparathyroidism, in addition to two abstracts detailing a retrospective natural history study of chronic hypoparathyroidism. Amolyt will also present preclinical data for AZP-3404, a peptide with a new and unique mechanism of action on fat and glucose metabolism. Details of the abstracts are as follows:

AZP-3601 Program
Title: A Single Administration of AZP-3601, a Novel, Long-Acting PTH Analog, Induces a Significant and Sustained Calcemic Response: Preliminary Data From a Randomized, Double-Blind, Placebo-Controlled Phase 1 Study

Session: P08 – Parathyroid and Rare Bone Disorders
Session Date/Time: March 20, 2021 at 11:00 AM – 11:59 PM EDT (On Demand)

Title: Clinical Burden And Practice Patterns In Patients With Chronic Hypoparathyroidism In The United States (US): A Claims Data Analysis Using Diagnosis-Based Criteria
Session: P08 – Parathyroid and Rare Bone Disorders
Session Date/Time: March 20, 2021 at 11:00 AM – 11:59 PM EDT (On Demand)

Title: Clinical Burden And Practice Patterns In Patients With Chronic Hypoparathyroidism In The United States (US): A Claims Data Analysis Using Surgery-Based Criteria
Session: P08 – Parathyroid and Rare Bone Disorders
Session Date/Time: March 20, 2021 at 11:00 AM – 11:59 PM EDT (On Demand)

AZP-3404 Program
Title: AZP-3404, a Peptide Analog of IGFBP-2, Induces Weight Loss and Improves Glucose Metabolism in Leptin-Resistant db/db Mice
Session: SESSION P15 – Bench to Bedside: Novel Mechanisms in Diabetes and Metabolism
Session Date/Time: March 20, 2021 at 11:00 AM – 11:59 PM EDT (On Demand)

Additional details can be found on the ENDO website and copies of the posters will be available on the Amolyt website once the presentations conclude.

About Hypoparathyroidism
Hypoparathyroidism is defined by a deficiency of parathyroid hormone (PTH) that results in decreased calcium and elevated phosphorus levels in the blood. Clinical manifestations of hypoparathyroidism vary and impact a large number of tissues and organ systems, including the muscles, brain, heart, and kidneys. Despite available treatments, patients frequently experience persistent, life-altering symptoms and reduced quality of life. In addition, they often develop kidney disease and have abnormal bone architecture. There are approximately 80,000 and 110,000 people with hypoparathyroidism in the U.S. and E.U., respectively, of which about 80% are women. More than two-thirds of women with hypoparathyroidism are peri- and menopausal women who are at an increased risk of developing osteoporosis. It is estimated that about 25% of people with hypoparathyroidism have chronic kidney disease or kidney failure, highlighting the importance of reducing urinary calcium excretion as a key treatment goal.

About AZP-3601
AZP-3601 is a therapeutic peptide designed to target a specific conformation of the parathyroid hormone (PTH) receptor in order to safely produce sustained levels of calcium in the blood and thereby manage the symptoms of hypoparathyroidism. The selective action of AZP-3601 through this distinct conformation of the PTH receptor is also intended to limit urine calcium excretion by stimulating calcium reabsorption by the kidney, consequently preventing chronic kidney disease. In addition, the unique receptor profile and short half-life of AZP-3601 are expected to preserve bone integrity, an important benefit since the majority of patients with hypoparathyroidism are middle-aged women often at increased risk of osteoporosis.

About AZP-3404
AZP-3404 is the first therapeutic peptide to leverage the biology of insulin-like growth factor binding protein 2 (IGFBP2), a key mediator of the beneficial effects of leptin on fat and glucose metabolism. The metabolic-regulating activity of IGFBP2 resides in a small peptide sequence located within its structure. AZP-3404 is a stabilized peptide analog of this sequence and is the first drug candidate to utilize and to reproduce the unique biology of IGFBP2. We are currently conducting pre-investigational new drug activities and exploring target indications for AZP-3404, especially rare metabolic diseases characterized by insulin resistance and/or obesity.

About Amolyt Pharma 
Amolyt Pharma is building on its team’s established expertise in therapeutic peptides to deliver life-changing treatments to patients suffering from rare endocrine and metabolic diseases. Its portfolio includes AZP-3601 as a potential treatment of hypoparathyroidism, AZP-3404, which is undergoing indication prioritization work, and AZP-3813, a small peptide series under evaluation to select a development candidate for the treatment of acromegaly. Amolyt Pharma aims to further expand and develop its portfolio by leveraging its global network in the field of endocrinology and with support from a strong syndicate of international investors. To learn more, visit www.amolytpharma.com or follow us on Twitter at @AmolytPharma.