Adrenal gland disorders

Glycomine’s Natural History Study Informs Potentially Lifesaving Update to Standard of Care for PMM2-CDG Patients

Retrieved on: 
Tuesday, June 29, 2021
Children, Biotechnology, Baby, Maternity, Health, Pharmaceutical, Other Science, Research, Genetics, Consumer, Science, Clinical trials, Endocrine system, Medical specialties, Organ systems, Adrenal gland disorders, Glucocorticoids, Corticosteroids, Congenital disorders of glycosylation, PMM2 deficiency, Adrenal insufficiency, Adrenocorticotropic hormone, Cortisol, Adrenal gland, PMM2-CDG (CDG-Ia), GLM101, a Potential Treatment for PMM2-CDG, Glycomine, Inc., PMM2-CDG (CDG-IA), GLM101, A POTENTIAL TREATMENT FOR PMM2-CDG, GLYCOMINE, INC.

These data provide key insights to improve standard of care, as early recognition of adrenal insufficiency and initiation of glucocorticoid replacement therapy and stress dosing could be lifesaving.

Key Points: 
  • These data provide key insights to improve standard of care, as early recognition of adrenal insufficiency and initiation of glucocorticoid replacement therapy and stress dosing could be lifesaving.
  • The authors conclude that morning cortisol and ACTH levels should be evaluated at least annually for all patients with PMM2-CDG.
  • Through an international collaboration, this study was the first to identify that patients with PMM2-CDG are at risk for secondary adrenal insufficiency and to suggest that morning cortisol and ACTH monitoring should become part of standard care in these patients.
  • The natural history study completed enrollment with 139 PMM2-CDG patients at 11 sites around the world (ClinicalTrials.gov Identifier: NCT03173300 ).

Antares Pharma Announces Submission of IND Application for ATRS-1902 for Adrenal Crisis Rescue

Retrieved on: 
Tuesday, June 22, 2021
Adrenal gland disorders, Organ systems, Drugs, Adrenal crisis, Adrenal insufficiency, Adrenal gland, Hydrocortisone, Insufficiency, Organs anatomy)

The IND application for ATRS-1902, and its corresponding development program, supports a proposed indication for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver hydrocortisone.

Key Points: 
  • The IND application for ATRS-1902, and its corresponding development program, supports a proposed indication for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver hydrocortisone.
  • Secondary adrenal insufficiency is more common, affecting approximately 150 to 280 people per million(2)(3), commented Dr. Peter Richardson, EVP, Research and Development and Chief Medical Officer of Antares Pharma.
  • Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, This IND submission represents a key milestone for Antares as we continue to advance our proprietary pipeline.
  • The FDA will review our IND application and determine the acceptability of the submission before Antares can commence the proposed phase 1 trial for ATRS-1902.

Zealand Pharma to Present Data on Glucagon Analog, Dasiglucagon, at the 81st Annual American Diabetes Association Scientific Sessions

Retrieved on: 
Wednesday, June 16, 2021
Hormones, Endocrine system, Organ systems, Zealand Pharma, Adrenal gland disorders, Animal products, Pancreatic hormones, Peptide hormones, Glucagon, Pheochromocytoma

Zealand Pharma to Present Data on Glucagon Analog, Dasiglucagon, at the 81st Annual American Diabetes Association Scientific Sessions

Key Points: 
  • Zealand Pharma to Present Data on Glucagon Analog, Dasiglucagon, at the 81st Annual American Diabetes Association Scientific Sessions
    Company to present six abstracts on ZEGALOGUE(dasiglucagon) injection, including one oral presentation
    Copenhagen, DK and Boston, MA, U.S. June 16, 2021 Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no.
  • "We are proud to share such a robust set of clinical data at this years ADA medical meeting, said Adam Steensberg, Executive Vice President, Research & Development of Zealand Pharma.
  • ZEGALOGUE is contraindicated in patients with pheochromocytoma because glucagon products may stimulate the release of catecholamines from the tumor.
  • Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, development and commercialization of innovative peptide-based medicines.

Eton Pharmaceuticals Acquires U.S. and Canadian Rights to ZENEO® Hydrocortisone Autoinjector

Retrieved on: 
Tuesday, June 15, 2021
Steroids, Drugs, Adrenal gland disorders, Organ systems, Glucocorticoids, Antipruritics, Hydrocortisone, Ketones, Mineralocorticoids, Autoinjector, Adrenal insufficiency

The ZENEO autoinjector is a revolutionary delivery system, and this product is a terrific strategic fit with our current adrenal insufficiency business.

Key Points: 
  • The ZENEO autoinjector is a revolutionary delivery system, and this product is a terrific strategic fit with our current adrenal insufficiency business.
  • ETON has successfully established strong relations with the patient communities and medical specialists that are its core focus.
  • ZENEO hydrocortisone is expected to be the first and only hydrocortisone autoinjector available for patients that require a rescue dose of hydrocortisone.
  • Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases.

Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV® (levoketoconazole) for the Treatment of Cushing’s Syndrome

Retrieved on: 
Thursday, June 3, 2021
Drugs, Organ systems, Health, Chloroarenes, CYP17A1 inhibitors, Acetamides, Dioxolanes, Adrenal gland disorders, Cushing's syndrome, Steroidogenesis inhibitor, Ketoconazole, Levoketoconazole

11,020,393 entitled, Methods of Treating Disease with Levoketoconazole which covers a method of treating Cushings syndrome patients with RECORLEV (levoketoconazole) who also take metformin for Type 2 diabetes.

Key Points: 
  • 11,020,393 entitled, Methods of Treating Disease with Levoketoconazole which covers a method of treating Cushings syndrome patients with RECORLEV (levoketoconazole) who also take metformin for Type 2 diabetes.
  • 9,918,984, covers methods of treating Cushings syndrome with levoketoconazole and will expire on January 10, 2026.
  • RECORLEV is an adrenal steroidogenesis inhibitor with a New Drug Application that is currently under review by the U.S. Food and Drug Administration for the treatment of endogenous Cushings syndrome.
  • RECORLEV has received orphan drug designation from the FDA and theEuropean Medicines Agencyfor the treatment of endogenous Cushing's syndrome.

Spruce Biosciences Presents Phase 2 Data for Tildacerfont in Adults with Congenital Adrenal Hyperplasia at 23rd European Congress of Endocrinology

Retrieved on: 
Monday, May 24, 2021
Health, Other Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Medicine, Medical specialties, Organ systems, Congenital adrenal hyperplasia, Adrenal gland disorders, Hyperplasia, Adrenal gland, Rare diseases, Congenital adrenal hyperplasia due to 11β-hydroxylase deficiency, Lipoid congenital adrenal hyperplasia, Tildacerfont, Spruce Biosciences, TILDACERFONT, SPRUCE BIOSCIENCES

Administration of tildacerfont to these patients did not lead to significant changes in these levels.

Key Points: 
  • Administration of tildacerfont to these patients did not lead to significant changes in these levels.
  • Tildacerfont has been evaluated in 171 patients across seven clinical trials in which it has been generally well tolerated.
  • Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet need.
  • Spruce is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy for patients suffering from classic congenital adrenal hyperplasia (CAH).

Spruce Biosciences to Participate in the RBC Capital Markets Global Healthcare Conference

Retrieved on: 
Thursday, May 13, 2021
Biotechnology, Pharmaceutical, Health, Medicine, Medical specialties, Branches of biology, Congenital adrenal hyperplasia, Adrenal gland disorders, CAH, Hyperplasia, Adrenal gland

An archived replay of the webcast will be available after the conclusion of the live presentation for approximately 30 days.\nSpruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet need.

Key Points: 
  • An archived replay of the webcast will be available after the conclusion of the live presentation for approximately 30 days.\nSpruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet need.
  • Spruce is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy for patients suffering from classic congenital adrenal hyperplasia (CAH).
  • Classic CAH is a serious and life-threatening disease with no known novel therapies approved in approximately 50 years.
  • To learn more, visit www.sprucebiosciences.com and follow us on Twitter @Spruce_Bio , LinkedIn , Facebook and YouTube .\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210513005039/en/\n'

Strongbridge Biopharma plc Announces Publication of Diabetes Subgroup Analysis from Phase 3 SONICS Study of RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome in Frontiers in Endocrinology

Retrieved on: 
Wednesday, April 7, 2021
Organ systems, Endocrine diseases, Health, Adrenal gland disorders, Anti-diabetic drugs, Cushing's syndrome, Anti-diabetic medication, Diabetes

Mean urinary-free cortisol (mUFC) normalization rate was similar in patients with and without diabetes at the end of the maintenance phase.

Key Points: 
  • Mean urinary-free cortisol (mUFC) normalization rate was similar in patients with and without diabetes at the end of the maintenance phase.
  • These improvements in glycemia markers were not due to changes in antidiabetic medication use, which were overall stable during treatment.
  • The poster, entitledResults from the Phase 3 Multicenter SONICS Study of Levoketoconazole: Subgroup Analysis of Cushings Syndrome in Patients with Diabetes Mellitus, can be accessed here .
  • SONICS is an open-label, Phase 3 study of RECORLEV as a treatment for endogenous Cushings syndrome that enrolled 94 patients at centers inNorth America,Europeand theMiddle East.

RECORDATI: POSITIVE RESULTS FROM THE PHASE III LINC 4 STUDY PRESENTED AT THE ENDOCRINE SOCIETY’S ANNUAL MEETING REINFORCE THE EFFICACY AND SAFETY OF ISTURISA® (OSILODROSTAT) IN CUSHING’S DISEASE

Retrieved on: 
Tuesday, March 23, 2021
Adrenal gland disorders, Chemical compounds, Orphan drugs, Organ systems, Imidazoles, Nitriles, Osilodrostat, Pyrroles, Health, Cushing's syndrome, Cushing's disease, Placebo-controlled study

These data provide further evidence of the benefits of Isturisa as an effective and well-tolerated oral treatment option for patients with Cushings disease.

Key Points: 
  • These data provide further evidence of the benefits of Isturisa as an effective and well-tolerated oral treatment option for patients with Cushings disease.
  • The key secondary endpoint was also met, with the majority (81%) of patients having normal mUFC levels at week 36.
  • We are delighted that the positive and statistically significant data from the LINC 4 study have been presented at the Endocrine Societys Annual Meeting.
  • Osilodrostat is an effective and well-tolerated treatment for Cushing's disease (CD): results from a Phase III study with an upfront, randomized, double-blind, placebo-controlled phase (LINC 4); presented at ENDO 2021, March 2021.

Strongbridge Biopharma plc Presents Detailed Results from Pivotal Phase 3 LOGICS Study of RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome at the 2021 Annual Meeting of the Endocrine Society (ENDO)

Retrieved on: 
Saturday, March 20, 2021
Adrenal gland disorders, Cushing's syndrome, Orphan drugs, Clinical medicine, Medicine, Health sciences

We remain confident that, if approved, RECORLEV may be an important new treatment option for patients with endogenous Cushings syndrome.

Key Points: 
  • We remain confident that, if approved, RECORLEV may be an important new treatment option for patients with endogenous Cushings syndrome.
  • On March 2, 2021, the Company announced it had submitted an NDA for RECORLEV for the treatment of endogenous Cushings syndrome to the FDA.
  • The Phase 3 program for RECORLEV includes SONICS and LOGICS: two multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat endogenous Cushings syndrome.
  • RECORLEV has received orphan drug designation from the FDA and theEuropean Medicines Agencyfor the treatment of endogenous Cushing's syndrome.