AZP-3404

LYON, France, and CAMBRIDGE, Mass., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, and PeptiDream Inc., a public Kanagawa, Japan-based biopharmaceutical company (“PeptiDream”)(Tokyo: 4587), today announced that Amolyt Pharma has exercised its option to globally license a portfolio of macrocyclic peptide growth hormone receptor antagonists (GHRA) under the terms of its research collaboration agreement with PeptiDream announced in December 2020. The identified, optimized drug candidate, AZP-3813, is being developed as a potential treatment for acromegaly to be used in combination with somatostatin analogues (SSAs) for patients who do not adequately respond to SSAs alone. “The addition of acromegaly as a target indication for our company is a strategic fit with our existing pipeline as we build a portfolio of therapeutic peptides to address unmet medical needs in rare endocrine and related diseases,” stated Thierry Abribat, Ph.D., founder and chief executive officer of Amolyt Pharma. “Without effective treatment, acromegaly can lead to a significant number of serious medical complications, and it is estimated that over 60% of patients still have uncontrolled insulin-like growth factor-1 (IGF-1) levels despite the use of current treatments, including SSAs. Through our collaboration with PeptiDream, we have evaluated several optimized macrocyclic peptide GHRAs, and we have selected AZP-3813 as our lead product candidate. We anticipate developing AZP-3813 as a potential next-generation GHRA therapeutic to provide greater efficacy to a broader range of patients with acromegaly. We are already working to advance this candidate through IND-enabling studies with the goal of initiating the first clinical trial by the end of 2022.” Patrick C. Reid, Ph.D., president and chief executive officer of PeptiDream, added, “We are very pleased to have identified an optimized drug candidate for further development in acromegaly through our research collaboration with Amolyt Pharma. With their peptide development capabilities, we believe Amolyt Pharma is well-suited to develop this therapeutic and to bring a much-needed new treatment option to acromegaly patients. We look forward to supporting the Amolyt Pharma team in this process and to continuing this productive partnership between our companies.” About AcromegalyAcromegaly is a rare chronic endocrine disorder that is typically caused by an adenoma (benign tumor) of the pituitary gland and characterized by abnormally high levels of growth hormone (GH), secreted by the pituitary gland, which leads to excess production of IGF-1. Common features in patients with acromegaly include enlargement of the hands, feet and jaw. Medical complications include cardiovascular disease, cardiomyopathy that can potentially lead to heart failure, impaired glucose tolerance with subsequent development of diabetes, hypogonadism, bone and joint disease, cerebrovascular events, sleep apnea and impaired respiratory function. The mean age of diagnosis is 40 to 45 years, but acromegaly is often diagnosed 4 to 10 years after onset due to its slow progression. It is estimated that there are 26,000 acromegaly patients in the United States and an additional 35,000 patients in the European Union. About Amolyt PharmaAmolyt Pharma, a clinical stage biotechnology company, is building on its team’s established expertise in therapeutic peptides to deliver life-changing treatments to patients suffering from rare endocrine and related diseases. Its portfolio includes AZP-3601, a long-acting PTH analog as a potential treatment of hypoparathyroidism, AZP-3813, a macrocyclic peptide growth hormone receptor antagonist for the potential treatment of acromegaly, and AZP-3404, which is undergoing indication selection 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  or follow us on Twitter at @AmolytPharma. About PeptiDreamPeptiDream Inc. is a public (TSE: 4587) biopharmaceutical company founded in 2006 employing its proprietary Peptide Discovery Platform System (PDPS), a state-of-the-art highly versatile discovery platform which enables the production of highly diverse (trillions) non-standard peptide libraries with high efficiency, for the identification of highly potent and selective hit candidates, which then can be developed into peptide-based, small molecule-based or peptide-drug conjugate therapeutics. PeptiDream aspires to be a world leader in drug discovery and development to address unmet medical needs and improve the quality of life of patients worldwide. For further information, please visit . At Amolyt: Media: Cherilyn Cecchini, M.D. LifeSci Communications ccecchini@lifescicomms.com +1.646.876.5196 Investors:Ashley RobinsonLifeSci Advisors, LLCarr@lifesciadvisors.com+1.617.430.7577 At PeptiDream: Investors and Media: Yuko Okimoto, Ph.D. IR & Public Affairs y-okimoto@peptidream.com

LYON, France and NEWTON, Mass., March 22, 2021 (GLOBE NEWSWIRE) -- Amolyt Pharma today presented positive data from the first cohorts of the single ascending dose portion of its Phase 1 clinical trial in healthy volunteers evaluating the company’s lead clinical candidate, AZP-3601, for the treatment of hypoparathyroidism. The data demonstrated a significant, sustained increase in blood calcium levels for at least 24 hours following a single administration of AZP-3601. The data were presented as a virtual poster at the Endocrine Society’s Annual Meeting (ENDO 2021). “We are delighted with this first set of clinical data highlighting AZP-3601’s unique mechanism of action,” said Thierry Abribat, Ph.D., founder and chief executive officer of Amolyt Pharma. “By targeting a specific conformation of the PTH1 receptor, these data demonstrate a prolonged serum calcium response, despite AZP-3601 having a very short half-life. We believe that this pharmacological pro ideally suited to fulfill the clinical needs of patients with hypoparathyroidism, including symptom management and prevention of kidney disease. Additionally, we believe the short pharmacokinetic pro AZP-3601 will maintain bone mass and integrity, a key benefit since the majority of patients with hypoparathyroidism are middle-aged women at risk of osteoporosis. We are encouraged by these early results and look forward to reporting additional data from the multiple ascending dose portion of the study later this year,” he added. The ongoing Phase 1 clinical program aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AZP-3601 following single and multiple ascending doses in healthy subjects, as well as in patients with hypoparathyroidism. In the first four cohorts of the double-blind, SAD study in healthy adults, healthy subjects aged 18-60 years were assigned to receive 5, 10, 20 or 40 µg of AZP-3601 or placebo at a ratio of 3:1. As compared with placebo controls, AZP-3601 treatment produced a clear, dose-dependent increase in mean albumin-adjusted serum calcium values from baseline. With the dose of 40 µg AZP-3601, mean albumin-adjusted serum calcium values were significantly increased, but stayed within normal laboratory range, and remained elevated through at least 24 hours post-administration. A dose-dependent decrease in mean endogenous serum parathyroid hormone was observed that correlates with the concomitant increase in mean serum calcium. These data provide initial evidence of the pharmacodynamic effect of AZP-3601 in healthy humans, characterized by a sustained and long-acting calcemic response following a single administration. Dr. Abribat concluded, “We are proud to have announced and presented these first clinical data for AZP-3601 at ENDO2021 that reflect our mission to deliver life-changing treatments to the endocrinology community, in particular for patients with hypoparathyroidism.” A copy of the Phase 1 data and copies of the additional presentations can be accessed on the Amolyt Pharma website. 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 pro 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 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-38XX, 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 or follow us on Twitter at @AmolytPharma. Contacts Investors: Ashley Robinson LifeSci Advisors, LLC arr@lifesciadvisors.com +1.617-775-5956 Media: Cherilyn Cecchini, M.D. LifeSci Communications ccecchini@lifescicomms.com +1.646.876.5196