Pituitary adenoma

Enrollment Completed in Phase 3 PATHFNDR-1 Study Evaluating Oral Paltusotine for the Treatment of Acromegaly

Retrieved on: 
Thursday, October 13, 2022

PATHFNDR-1 is one of two ongoing, placebo-controlled Phase 3 studies evaluating the safety and efficacy of once-daily oral paltusotine in acromegaly patients.

Key Points: 
  • PATHFNDR-1 is one of two ongoing, placebo-controlled Phase 3 studies evaluating the safety and efficacy of once-daily oral paltusotine in acromegaly patients.
  • The Phase 3 PATHFNDR-2 studys enrollment is ongoing and topline results are expected in the fourth quarter of 2023.
  • We would like to thank study participants and clinical research professionals for their interest and contributions to the PATHFNDR-1 study.
  • In Phase 2 studies, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily oral paltusotine.

New Long-Term Safety and Efficacy Data Presented with Paltusotine in Participants Living with Acromegaly

Retrieved on: 
Tuesday, September 6, 2022

SAN DIEGO, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals (Nasdaq: CRNX) today announced that Monica R. Gadelha, MD, PhD, professor of endocrinology at the Medical School of the Universidade Federal do Rio de Janeiro and a principal investigator in the Phase 2 ACROBAT program, presented new data from the planned two-year interim analysis of the ACROBAT Advance open label extension (OLE) study at the 35th Brazilian Congress of Endocrinology and Metabolism (CBEM).

Key Points: 
  • This preliminary data, combined with the preference participants had for oral paltusotine over the injected standard-of-care, speaks to the potential paltusotine may have as a long-term therapy for acromegaly.
  • Dr. Gadelha will present an additional poster of the Advance OLE data at the European Neuroendocrine Association (ENEA) meeting.
  • That presentation, titled Long-Term Treatment with Oral Paltusotine for Acromegaly: Results from the ACROBAT Advance study will be made on September 9th.
  • In Phase 2 trials, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily paltusotine.

New Long-Term Safety and Efficacy Data for Investigational Compound Paltusotine to be Presented at the Brazilian Congress of Endocrinology and Metabolism

Retrieved on: 
Friday, September 2, 2022

Acromegaly is a serious disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone.

Key Points: 
  • Acromegaly is a serious disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone.
  • Paltusotine is an investigational, orally available nonpeptide agonist that is designed to be highly selective for the somatostatin receptor type 2 (SST2).
  • In Phase 2 trials, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily paltusotine.
  • All of the companys drug candidates are orally delivered, small molecule new chemical entities resulting from in-house drug discovery efforts.

Recordati Rare Diseases Announce Publication of Long-term Outcomes From the Extension to the Phase III LINC 3 Study of Isturisa® (Osilodrostat) in Patients With Cushing’s Disease in the European Journal of Endocrinology

Retrieved on: 
Wednesday, August 31, 2022

Median duration of exposure to Isturisa from core study baseline to end of the extension was 130 weeks (range 1245).

Key Points: 
  • Median duration of exposure to Isturisa from core study baseline to end of the extension was 130 weeks (range 1245).
  • Recordati Rare Diseases is committed to improving the lives of patients with this rare, debilitating and life-threatening condition.
  • Long-term outcomes of osilodrostat in Cushings disease: LINC 3 study extension The European Journal of Endocrinology 2022.
  • Efficacy and safety of osilodrostat in patients with Cushing's disease (LINC 3): a multicentre phase III study with a double-blind, randomised withdrawal phase.

Recordati Rare Diseases Announces Several Scientific Abstracts to Be Presented at the Upcoming Endo Society Annual Meeting

Retrieved on: 
Wednesday, June 8, 2022

Recordati Rare Diseases Inc. announced today that various scientific abstracts have been accepted and will be presented onsite at the ENDO 2022 annual meeting being held in Atlanta, Georgia from June 11 14, 2022.

Key Points: 
  • Recordati Rare Diseases Inc. announced today that various scientific abstracts have been accepted and will be presented onsite at the ENDO 2022 annual meeting being held in Atlanta, Georgia from June 11 14, 2022.
  • For more information visit www.isturisa.com
    About Recordati Rare Diseases Inc.
    Recordati Rare Diseases Inc. is a biopharmaceutical company committed to providing often-overlooked orphan therapies to the underserved rare disease communities of the United States.
  • Recordati Rare Diseases mission is to reduce the impact of extremely rare and devastating diseases by providing urgently needed therapies.
  • We work side-by-side with rare disease communities to increase awareness, improve diagnosis and expand availability of treatments for people with rare diseases.

Phase III LINC 3 Study Demonstrates That ISTURISA® (osilodrostat) Improves Physical Features Associated With Hypercortisolism in Patients With Cushing’s Disease

Retrieved on: 
Friday, May 13, 2022

Recordati Rare Diseases Inc. announced today that the Phase III LINC 3 study demonstrates ISTURISA (osilodrostat) improves physical features associated with hypercortisolism in patients with Cushings disease.

Key Points: 
  • Recordati Rare Diseases Inc. announced today that the Phase III LINC 3 study demonstrates ISTURISA (osilodrostat) improves physical features associated with hypercortisolism in patients with Cushings disease.
  • Patients with Cushings disease experience multiple physical manifestations of hypercortisolism that may reduce quality of life.
  • According to the abstract entitled Osilodrostat Therapy Improves Physical Features Associated with Hypercortisolism in Patients with Cushings Disease: Findings from the Phase III LINC 3 Study, 137 adult Cushings disease patients with mUFC >1.5 x the upper limit of normal were enrolled in the 48-week core phase to evaluate the safety and efficacy of ISTURISA in patients with Cushings disease.
  • Changes to physical features caused by Cushings disease can have a significant impact on patient health and well-being.

Recordati Rare Diseases Announces Multiple Scientific Abstracts to Be Highlighted at American Association of Clinical Endocrinology

Retrieved on: 
Tuesday, May 10, 2022

Recordati Rare Diseases Inc. announced today that various scientific abstracts have been accepted and will be featured onsite at the American Association of Clinical Endocrinology (AACE) annual meeting being held in San Diego, California from May 12 14, 2022.

Key Points: 
  • Recordati Rare Diseases Inc. announced today that various scientific abstracts have been accepted and will be featured onsite at the American Association of Clinical Endocrinology (AACE) annual meeting being held in San Diego, California from May 12 14, 2022.
  • Key Onsite abstracts presented by Alberto Pedroncelli MD, Head of Clinical Development & Medical Affairs, Global Endocrinology, Recordati AG.
  • For more information visit www.isturisa.com
    About Recordati Rare Diseases Inc.
    Recordati Rare Diseases Inc. is a biopharmaceutical company committed to providing often-overlooked orphan therapies to the underserved rare disease communities of the United States.
  • Recordati Rare Diseases mission is to reduce the impact of extremely rare and devastating diseases by providing urgently needed therapies.

Recordati Rare Diseases Announce Publication in the Journal of Clinical Endocrinology & Metabolism of the Phase III LINC 4 Study Confirming the Efficacy and Safety of Isturisa® (Osilodrostat) in Patients With Cushing’s Disease

Retrieved on: 
Tuesday, March 29, 2022

Improvements in cardiovascular and metabolic parameters of Cushings disease, including blood pressure and blood glucose metabolism, were seen by week 12 and were maintained throughout the study.

Key Points: 
  • Improvements in cardiovascular and metabolic parameters of Cushings disease, including blood pressure and blood glucose metabolism, were seen by week 12 and were maintained throughout the study.
  • Osilodrostat rapidly lowered cortisol excretion to normal in most patients with Cushings disease and maintained normal levels throughout the core phase of the study.
  • Recordati Rare Diseases is committed to improving the lives of patients with this rare, debilitating and life-threatening condition.
  • Efficacy and safety of osilodrostat in patients with Cushing's disease (LINC 3): a multicentre phase III study with a double-blind, randomised withdrawal phase.

Crinetics Pharmaceuticals and Sanwa Kagaku Kenkyusho Enter into Exclusive Licensing Agreement for the Development and Commercialization of Paltusotine in Japan

Retrieved on: 
Monday, February 28, 2022

In addition, upon market approval of paltusotine in Japan, Crinetics will be eligible to receive tiered royalties based on net product sales.

Key Points: 
  • In addition, upon market approval of paltusotine in Japan, Crinetics will be eligible to receive tiered royalties based on net product sales.
  • Sanwa will have an exclusive right to develop and commercialize the product in Japan and will be responsible for leading the development and commercialization of paltusotine for acromegaly and NETs in Japan.
  • Crinetics retains all rights to develop and commercialize paltusotine outside Japan.
  • In Japan, Sanwa expects to initiate Phase 1 development with paltusotine in 2022.

Crinetics Pharmaceuticals Presenting New Data from Open Label Extension Trial of Paltusotine in Acromegaly at the Society for Endocrinology BES Congress

Retrieved on: 
Monday, November 8, 2021

This was true for patients with controlled or uncontrolled IGF-1 at baseline while treated with injected SRLs.

Key Points: 
  • This was true for patients with controlled or uncontrolled IGF-1 at baseline while treated with injected SRLs.
  • It was designed by the Crinetics discovery team to provide a once-daily option for patients with acromegaly and neuroendocrine tumors.
  • In Phase 2 trials, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily oral paltusotine.
  • Crinetics also plans to advance paltusotine into a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors.