Adrenal gland

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

Retrieved on: 
Tuesday, June 29, 2021

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

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.

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

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

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'

Spruce Biosciences Reports First Quarter 2021 Financial Results and Provides Corporate Updates

Retrieved on: 
Wednesday, May 12, 2021

In the pediatric classic CAH population, the imbalance between excess adrenal androgens and glucocorticoids can lead to irreversible impacts on childhood development.

Key Points: 
  • In the pediatric classic CAH population, the imbalance between excess adrenal androgens and glucocorticoids can lead to irreversible impacts on childhood development.
  • Stock-based compensation for the first quarter ended March 31, 2021 was $1.1 million.
  • Spruce management uses these non-GAAP financial measures to monitor and evaluate its operating results and trends on an on-going basis, and internally for operating, budgeting and financial planning purposes.
  • The non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP but should not be considered a substitute for or superior to GAAP results.\n"

China Budesonide Market Report 2021: Sales Decreased by 29.30% in 2020 - Forecast to 2025 - ResearchAndMarkets.com

Retrieved on: 
Friday, April 30, 2021

b'The "Investigation Report on China\'s Budesonide Market 2021-2025" report has been added to ResearchAndMarkets.com\'s offering.\nSales of Budesonide increased from 2016 to 2019, with a CAGR of approximately 9.26%.

Key Points: 
  • b'The "Investigation Report on China\'s Budesonide Market 2021-2025" report has been added to ResearchAndMarkets.com\'s offering.\nSales of Budesonide increased from 2016 to 2019, with a CAGR of approximately 9.26%.
  • However, the sales of Budesonide decreased by 29.30% in 2020 because of the COVID-19 pandemic.
  • With the improvement of the epidemic situation, the analyst predicts that the sales of Budesonide in China will have a recovery growth in the short run.\nBudesonide is an adrenal cortex hormone medicine.
  • Thus, the analyst analyzes that in addition to the recovery growth, the sales of Budesonide will increase in 2021-2025 as the market expands.\n2 Sales of Budesonide in China, 2016-2020\n2.3 Sales of Budesonide by Dosage Form in China, 2016-2020\n'

Spruce Biosciences Presents Phase 1 and 2 Data for Tildacerfont in Adults with Congenital Adrenal Hyperplasia from Endocrine Society’s 2021 Annual Meeting

Retrieved on: 
Wednesday, March 17, 2021

Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet need, presented data from its Phase 1 and 2 programs of tildacerfont in adults with classic congenital adrenal hyperplasia (CAH) from the Endocrine Societys 2021 Annual Meeting , taking place virtually March 20 23, 2021.

Key Points: 
  • Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet need, presented data from its Phase 1 and 2 programs of tildacerfont in adults with classic congenital adrenal hyperplasia (CAH) from the Endocrine Societys 2021 Annual Meeting , taking place virtually March 20 23, 2021.
  • Participants in the study underwent concurrent salivary and serum concentration measurements of androstenedione (A4), 17-hydroxyprogesterone (17-OHP) and testosterone (T).
  • 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).

Corcept Therapeutics Initiates Phase 1b Trial of Relacorilant Plus Pembrolizumab (Keytruda®) in Patients with Adrenal Cancer with Cortisol Excess

Retrieved on: 
Monday, March 15, 2021

Our trial will examine whether adding relacorilant to pembrolizumab therapy will reduce cortisol-activated immune suppression sufficiently to help pembrolizumab achieve its intended tumor-killing effect, while relacorilant treats the Cushings syndrome caused by excess cortisol activity.

Key Points: 
  • Our trial will examine whether adding relacorilant to pembrolizumab therapy will reduce cortisol-activated immune suppression sufficiently to help pembrolizumab achieve its intended tumor-killing effect, while relacorilant treats the Cushings syndrome caused by excess cortisol activity.
  • The open-label, Phase 1b trial has a planned enrollment of 20 patients with metastatic or unresectable adrenal cancer with cortisol excess at five sites in the United States.
  • Corcept is studying relacorilant in a variety of serious disorders, including Cushings syndrome and adrenal, ovarian and pancreatic cancer.
  • In this press release, forward-looking statements include those concerning the clinical attributes of relacorilant and its effects in patients with adrenal cancer.

Edison Investment Research Limited: Diurnal Group (DNL): Initiation - Improving treatments for endocrine disorders

Retrieved on: 
Monday, March 15, 2021

We are initiating coverage on Diurnal Group, which is developing and commercialising multiple products from the class of steroid hormones.

Key Points: 
  • We are initiating coverage on Diurnal Group, which is developing and commercialising multiple products from the class of steroid hormones.
  • These products are oral formulations of hydrocortisone developed to treat disorders of the adrenal glands.
  • Additionally, Diurnal is developing an oral testosterone, DITEST, which will be re-entering the clinic in 2021.
  • About Edison: Edison is a leading research and investor relations consultancy, connecting listed companies to the widest pool of global investors.

Crinetics Pharmaceuticals Lead ACTH Antagonist for Congenital Adrenal Hyperplasia and Cushing’s Disease (CRN04894) Advances into Phase 1 Study

Retrieved on: 
Thursday, February 4, 2021

Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics , stated, ACTH is the central hormone mediating the endocrine stress response in humans.

Key Points: 
  • Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics , stated, ACTH is the central hormone mediating the endocrine stress response in humans.
  • This is a major step forward towards a new class of therapeutic for patients suffering from devastating diseases of the stress endocrine axis, such as Cushings disease or congenital adrenal hyperplasia.
  • It has the potential to offer a life-saving treatment option to patients with Cushings disease, CAH and related diseases, said Alan Krasner, M.D., Chief Medical Officer of Crinetics .
  • In the SAD phase, study participants will receive synthetic ACTH during the study to replicate conditions of excess ACTH and create a baseline of elevated serum cortisol.