Amolyt Pharma to Present New Phase 1 Data on AZP-3601, its Parathyroid Hormone Analog for Hypoparathyroidism, and Preclinical Data on AZP-3404 at Upcoming Scientific Conferences
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New data from all cohorts of Phase 1 Single Ascending Dose clinical trial accepted for oral presentation at e-ECE 2021
LYON, France, and Cambridge, MA, May 18, 2021 – Amolyt Pharma, a global pharmaceutical company specializing in developing therapeutic peptides for rare endocrine and metabolic diseases, today announced that it will be presenting four abstracts at the 23rd European Congress of Endocrinology (e-ECE) 2021 to be held virtually from May 22-26, 2021 as well as an abstract at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2021 to be held virtually from May 17-20, 2021.
At e-ECE 2021, Amolyt Pharma will present new data from all cohorts from its Phase 1 Single Ascending Dose clinical trial evaluating AZP-3601, a parathyroid hormone (PTH) analog specifically designed for the treatment of hypoparathyroidism. In addition, Amolyt will present two retrospective Natural History Study methods to identify patients with chronic hypoparathyroidism. Finally, Amolyt will present preclinical data for AZP-3404, a peptide with a new and unique potential mechanism of action on fat and glucose metabolism. At ISPOR 2021, Amolyt will present proposed methods to identify patients with chronic hypoparathyroidism using claims data in the United States (US). Details of the abstracts are as follows:
ISPOR 2021 Poster Presentation
Title: Methods to Identify Patients with Chronic Hypoparathyroidism in the United States (US) Using Claims Data
Session: Virtual Poster Discussion Session 3, Rare & Orphan Diseases, Methodological & Statistical Research
Session Date/Time: Wednesday, May 19, 2021 from 11:30 AM – 1:45 PM EDT
e-ECE 2021 Oral Presentations
Title: Safety, Tolerability and Pharmacodynamics of AZP-3601, a Novel Long-Acting PTH Analog, in Healthy Adults: Data From a Randomized, Double-Blind, Placebo-Controlled Phase 1 Study
Session: Channel 1, Oral Communications 6: Calcium and Bone
Session Date/Time: Tuesday, May 25, 2021 from 14:30 – 15:30 CET
Title: Improved Glucose Metabolism and Decreased Weight Gain in Leptin-Resistant, IGFBP2-Deficient, db/db Mice Induced by AZP-3404, a 9-Amino Acid Analog of IGFBP2
Session: Channel 2, Oral Communications 12: Diabetes, Obesity, Metabolism and Nutrition
Session Date/Time: Wednesday, May 26, 2021 from 14:30 – 15:30 CET
e-ECE 2021 Poster Presentations
Title: Assessment of Clinical Burden and Practice Patterns in Patients with Chronic Hypoparathyroidism in the United States (US): A Claims Data Analysis Using Diagnosis-Based Criteria
Session: Thyroid (non cancer)
Title: Assessment of Clinical Burden and Practice Patterns in Patients with Chronic Hypoparathyroidism in the United States (US): A Claims Data Analysis Using a Surgery-Based Approach
Session: Thyroid (non cancer)
Additional details can be found on the ISPOR and e-ECE websites and copies of the presentations and abstracts will be available on the Amolyt website once the presentations conclude.
Hypoparathyroidism is defined by a deficiency of parathyroid hormone (PTH) that may result 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.
AZP-3601 is an investigational 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. AZP-3601 is designed to be selectively active through this distinct conformation of the PTH receptor and to limit urine calcium excretion by restoring calcium reabsorption by the kidney, with the goal of consequently preventing chronic kidney disease. In addition, AZP-3601 is designed to have unique receptor profile and short half life, which would have the potential to preserve bone integrity, an important potential benefit since the majority of patients with hypoparathyroidism are middle-aged women often at increased risk of osteoporosis.
AZP-3404 is believed to be the first investigational therapeutic peptide designed to leverage the biology of insulin-like growth factor binding protein 2 (IGFBP-2), a key mediator of the beneficial effects of leptin on fat and glucose metabolism. The metabolic-regulating activity of IGFBP-2 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 designed to utilize and to reproduce the unique biology of IGFBP-2. 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 for patients with hypoparathyroidism, AZP-3813, a small peptide series under evaluation to select a development candidate for the treatment of patients with acromegaly and AZP-3404, which is undergoing indication prioritization work. 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.
Cherilyn Cecchini, M.D.
LifeSci Advisors, LLC