Hypercalciuria

Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Date of authorisation: 12/12/2022, Revision: 3, Status: Authorised

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Tuesday, January 2, 2024
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Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Date of authorisation: 12/12/2022, Revision: 3, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Date of authorisation: 12/12/2022, Revision: 3, Status: Authorised

BridgeBio Pharma Announces New England Journal of Medicine Publication of Positive Encaleret Proof-of-Concept Phase 2b Results in Patients with Autosomal Dominant Hypocalcemia Type 1 (ADH1)

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Tuesday, October 10, 2023
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“Conventional therapy for ADH1 includes raising the blood calcium levels with calcium supplements and activated vitamin D, taken in multiple doses throughout day.

Key Points: 
  • “Conventional therapy for ADH1 includes raising the blood calcium levels with calcium supplements and activated vitamin D, taken in multiple doses throughout day.
  • But this burdensome regimen may also increase urine calcium levels above normal, which can damage the kidney, leading to kidney failure in worst-case scenarios.
  • People with ADH1 need better treatments, so they are not constantly walking on a tightrope.
  • As part of the Phase 2b study, participants completed one or two 5-day inpatient dose-ranging periods, followed by a 24-week outpatient period.

Aurinia Showcases Three Oral Presentations for LUPKYNIS® (voclosporin) at 2023 European Renal Association Annual Meeting in Milan, Italy

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Tuesday, June 20, 2023
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The findings presented at ERA this week show that voclosporin achieved a 50% proteinuria reduction at 28 days, compared to 57 days in the control arm (p90% renal reabsorption was observed for both CSA and TAC in this study, whereas the renal handling of VCS suggested a significant component of tubular secretion.

Key Points: 
  • The findings presented at ERA this week show that voclosporin achieved a 50% proteinuria reduction at 28 days, compared to 57 days in the control arm (p
  • “Additionally, in two pre-clinical animal models, voclosporin showed a higher rate of renal secretion, lower overall kidney exposure, and no associated hypercalciuria or hypomagnesemia, compared to the legacy, first-generation CNIs.
  • Higher drug exposure and >90% renal reabsorption was observed for both CSA and TAC in this study, whereas the renal handling of VCS suggested a significant component of tubular secretion.
  • The data showed that the tubulotoxicity observed with TAC is not apparent with VCS treatment at clinically relevant doses.3

Extend Biosciences Announces Positive Data from Phase 1 Trial of EXT608 for the Treatment of Hypoparathyroidism

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Thursday, May 11, 2023
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Extend Biosciences (“ExtendBio”), a clinical stage biopharmaceutical company utilizing a proprietary platform technology to develop advanced therapeutic peptides, today announced positive results from its first-in-human trial of EXT608.

Key Points: 
  • Extend Biosciences (“ExtendBio”), a clinical stage biopharmaceutical company utilizing a proprietary platform technology to develop advanced therapeutic peptides, today announced positive results from its first-in-human trial of EXT608.
  • An interim data analysis shows that EXT608 was safe and well tolerated, with no serious adverse events reported.
  • The data provide a strong rationale to proceed to the next stage of clinical development and also offer valuable guidance for selecting a starting dose in the Phase 2 trial.
  • The ongoing Phase 1 trial is a double-blind, randomized, placebo-controlled trial involving 24 healthy participants across 6 cohorts who receive a single ascending subcutaneous dose of EXT608.

Amolyt Pharma Announces Phase 3 Clinical Trial of Eneboparatide for the Treatment of Hypoparathyroidism following Positive End of Phase 2 Meeting with FDA

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Tuesday, May 2, 2023
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LYON, France and CAMBRIDGE, Mass., May 02, 2023 (GLOBE NEWSWIRE) -- Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced that it will initiate its Phase 3 clinical trial of eneboparatide, a long-acting parathyroid hormone 1 (PTH1) receptor agonist, in patients with hypoparathyroidism following the receipt of End-of-Phase 2 guidance from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • “We appreciate the constructive discussions with the FDA during the End-of-Phase 2 meeting and have designed our trial in line with the Agency’s guidance.
  • We believe the Calypso study will be the largest prospective randomized clinical trial in hypoparathyroidism to date, representing a major milestone for the patient community as well as for Amolyt Pharma,” said Thierry Abribat, Ph.D., founder and chief executive officer of Amolyt Pharma.
  • “We look forward to further evaluating the clinical potential of eneboparatide to uniquely address key treatment goals in hypoparathyroidism.
  • The Calypso trial will be conducted in more than 50 centers in the United States, Europe, Canada, and the United Kingdom.

EQS-News: Andera Partners participates in the $138 Million Series C Financing of Amolyt Pharma led by Sofinnova Partners and co-led by Intermediate Capital Group

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Sunday, January 22, 2023
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Funds will be used to complete phase 3 clinical development of eneboparatide (AZP-3601) for hypoparathyroidism, and advance AZP-3813 into the clinic for acromegaly.

Key Points: 
  • Funds will be used to complete phase 3 clinical development of eneboparatide (AZP-3601) for hypoparathyroidism, and advance AZP-3813 into the clinic for acromegaly.
  • $138M) Series C equity financing.
  • The financing was led by Sofinnova Partners and co-led by Intermediate Capital Group (ICG).
  • Cédric Moreau, partner at Sofinnova Partners and Toby Sykes, managing director at ICG, will join Amolyt’s Board of Directors.

Amolyt Pharma Announces $138 Million Series C Financing led by Sofinnova Partners and co-led by Intermediate Capital Group

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Friday, January 6, 2023
ICG, CTX, Novo Holdings A/S, Serum, Acromegaly, Calcium, Biomarker, Intermediate Capital Group, Series, Sofinnova, Growth, Patient, Hypercalciuria, Hypoparathyroidism, Vitamin D, Therapy, Pharmaceutical industry

$138M) Series C equity financing.

Key Points: 
  • $138M) Series C equity financing.
  • The financing was led by Sofinnova Partners and co-led by Intermediate Capital Group (ICG).
  • Cédric Moreau, partner at Sofinnova Partners and Toby Sykes, managing director at ICG, will join Amolyt’s Board of Directors.
  • “We are very pleased to complete this large Series C financing, which will enable us to build on our momentum with eneboparatide and accelerate the growth of Amolyt Pharma and its pipeline globally,” stated Thierry Abribat, Ph.D., founder, and chief executive officer of Amolyt Pharma.

Amolyt Pharma Announces Positive Safety and Efficacy Results from Second Patient Cohort in its Phase 2a Trial of AZP-3601 for the Treatment of Hypoparathyroidism

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Wednesday, October 12, 2022
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LYON, France and CAMBRIDGE, Mass., Oct. 12, 2022 (GLOBE NEWSWIRE) -- Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced positive results from the second patient cohort in its Phase 2a clinical proof of concept trial of AZP-3601, a PTH1 receptor agonist, which the company is developing as a potential treatment for hypoparathyroidism.

Key Points: 
  • Consistent with Cohort 1, mean albumin-adjusted serum calcium (AdsCa) remained within the target range.
  • 24-hour urinary excretion of calcium was rapidly normalized in all but one patient, including those with hypercalciuria at baseline.
  • Consistent with the findings in bone biomarkers, bone mineral density (BMD) was stable, including in patients with osteopenia.
  • In this second cohort, 16 patients with hypoparathyroidism received daily subcutaneous injections of AZP-3601 during a four-week main treatment period, followed by an eight-week extension phase.

Amolyt Pharma Announces Positive Efficacy and Safety Data from First Cohort of Phase 2a Study of AZP-3601 in Patients with Hypoparathyroidism at the American Society for Bone and Mineral Research 2022 Annual Meeting

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Monday, September 12, 2022
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Normalization of urinary calcium was rapidly achieved in all patients, including those with hypercalciuria at baseline, together with restoration of balanced bone resorption/formation activity.

Key Points: 
  • Normalization of urinary calcium was rapidly achieved in all patients, including those with hypercalciuria at baseline, together with restoration of balanced bone resorption/formation activity.
  • We are very pleased with the compelling results from the first patient cohort of this ongoing trial, said Mark Sumeray, M.D., chief medical officer of Amolyt Pharma.
  • 24-hour urinary excretion of calcium was rapidly normalized in all cases including in patients with hypercalciuria at baseline.
  • Approximately 80% of the estimated 80,000 people in the U.S. and 110,000 in the European Union with hypoparathyroidism are women.

HypoPARAthyroidism Association Launches the First-of-its-Kind Patient-Powered Data Platform to Advance Patient Care

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Tuesday, June 21, 2022
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LEMOORE, Calif., June 21, 2022 (GLOBE NEWSWIRE) -- HypoPARAthyroidism Association, Inc., an organization dedicated to improving the lives of people impacted by hypoparathyroidism (HypoPARA) through education, support, research, and advocacy, today announced the launch of the first-of-its-kind Patient-Powered Data Platform. The platform will aggregate data voluntarily entered by patients about their disease, medical history and quality of life, with the long-term goal of building a patient-driven data repository that can help healthcare providers, researchers and clinicians make informed decisions about the treatments for people living with HypoPARA. This launch is a critical first step to broadening the HypoPARA research journey and an important resource for patients and their caregivers to advance care for the HypoPARA communities.

Key Points: 
  • This launch is a critical first step to broadening the HypoPARA research journey and an important resource for patients and their caregivers to advance care for the HypoPARA communities.
  • The Data Platform is designed to inform researchers understanding of how the symptoms of HypoPARA, or response to therapy, change over time.
  • The Patient-Powered Data Platform will also make it easier to identify endocrinologists and other specialists who may have expertise in treating HypoPARA.
  • HypoPARAthyroidism Association, Inc., is dedicated to improving the lives of people impacted by hypoparathyroidism (HypoPARA) through education, support, research, and advocacy.