Osteocalcin

NextCure Publishes Non-Clinical Data Demonstrating Anti-Siglec-15 Treatment Prevented Bone Loss Due to Immobilization from Acute Spinal Cord Injury

Retrieved on: 
Thursday, December 21, 2023
Veteran, Osteocalcin, Skeleton, Risk, Osteoporosis, Immobilization, Fracture, Messenger, Tibia, Tetraplegia, BSP, Society, Osteoblast, Cancer, Femur, Blood, S15, Manuscript, Patient, Therapy, Osteoclast, BMD, Medical imaging

The data demonstrated that NC605, a novel anti-Siglec-15 (S15) antibody, prevented bone loss, but more importantly preserved bone strength in animal models of severe immobilization resulting from acute spinal cord injury.

Key Points: 
  • The data demonstrated that NC605, a novel anti-Siglec-15 (S15) antibody, prevented bone loss, but more importantly preserved bone strength in animal models of severe immobilization resulting from acute spinal cord injury.
  • Following spinal cord injury, patients typically suffer rapid and extensive bone loss.
  • While anti-resorptive therapies have shown some efficacy in inhibiting bone loss, these agents also inhibit bone formation.
  • Blood and bone structure analyses revealed that the anti-S15 antibody was able to greatly inhibit bone resorption while maintaining bone formation and quality.

Preclinical Data Demonstrate Potential Application of Anti-Siglec-15 Treatment in Bone Disease

Retrieved on: 
Tuesday, September 5, 2023
Osteoporosis, Therapy, Blood, Osteocalcin, Tibia, Cancer, Quality of life, Mount Sinai, BMD, Bone disease, Immobilization, Multiple sclerosis, Messenger, Military personnel, Osteoblast, BSP, Patient, Icahn School of Medicine at Mount Sinai, Femur, Osteoclast, SCI, Vaccine, Medical imaging, S15, Veteran, Medicine

While anti-resorptive therapies have shown some efficacy in inhibiting bone loss, these agents also inhibit bone formation.

Key Points: 
  • While anti-resorptive therapies have shown some efficacy in inhibiting bone loss, these agents also inhibit bone formation.
  • In preclinical testing, NC605 has been shown to prevent bone loss by inhibiting osteoclast maturation and bone resorption by binding S15, which is expressed on the cell surface of immature osteoclasts and upregulated in differentiated osteoclasts.
  • Blood and bone structure analyses revealed that the anti-S15 antibody was able to greatly inhibit bone resorption while maintaining bone quality.
  • Title: Development of a Novel Therapeutic, anti-Siglec-15 Antibody, to Reduce Bone Loss and Enhance Bone Integrity after Acute Spinal Cord Injury-induced Immobilization

Sparrow Pharmaceuticals Expands Phase 2 Clinical Trial of SPI-62 with Prednisolone for Polymyalgia Rheumatica with Second Cohort

Retrieved on: 
Wednesday, March 8, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Prednisolone, Rheumatology, Skin, Patient, Metabolism, Toxicity, HSD, PMR, C-reactive protein, Tissue, NCT, Glucocorticoid, Osteocalcin, Endocrinology, Polymyalgia rheumatica, Knowledge, Doctor of Philosophy, Disease, Liver, Medication, Pharmaceutical industry

“This trial is expected to teach us whether SPI-62 can separate the desired and undesired effects of prednisolone,” said David Katz, PhD, Chief Scientific Officer of Sparrow.

Key Points: 
  • “This trial is expected to teach us whether SPI-62 can separate the desired and undesired effects of prednisolone,” said David Katz, PhD, Chief Scientific Officer of Sparrow.
  • Patients with PMR taking a daily 10mg oral dose of prednisolone may be eligible for the trial.
  • For the PMR trial a fixed-dose combination of prednisolone and SPI-62 will be referred to as SPI-47.
  • To learn more about Sparrow Pharmaceuticals and its clinical trials, visit the website at www.sparrowpharma.com .

Entera Bio Provides Corporate Updates and Financial Results for the Third Quarter of 2022

Retrieved on: 
Thursday, November 10, 2022
GLOBE, Femoral neck, Teriparatide, Investment, Osteoporosis, Patent, Annual general meeting, Food, Tablet, Society, Injection, Population, Protein, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, R, NASDAQ, Oral, Blood, PTH, Hypo, BMD, American Society for Bone and Mineral Research, Research, Woman, Patient, D&O, Vertebral column, Insurance, NDA, Menopause, Fracture, FDA, Trial of the century, Fine chemical, Dietary supplement, Pharmaceutical industry, Renewable energy, Entera, Osteocalcin, Amgen

JERUSALEM, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (Entera or the Company) a leader in the development of orally delivered peptides and therapeutic proteins, today announced its financial results for the third quarter of 2022 and provided the following corporate updates.

Key Points: 
  • JERUSALEM, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (Entera or the Company) a leader in the development of orally delivered peptides and therapeutic proteins, today announced its financial results for the third quarter of 2022 and provided the following corporate updates.
  • Results for Third Quarter Ended September 30, 2022
    Revenues for the three months ended September 30, 2022 were $8,000 compared to $140,000 for the three months ended September 30, 2021.
  • As of September 30, 2022, Entera had cash and cash equivalents of $14.3 million, compared to $17.3 million as of June 30, 2022.
  • Entera expects that its existing cash resources are sufficient to fund operations through the second quarter of 2023.

Entera Bio Announces FDA Agreement for a Single Phase 3 Clinical Trial to Support an NDA for EB613 for the Treatment of Osteoporosis

Retrieved on: 
Thursday, October 6, 2022
Femoral neck, Population, BMD, Woman, NDA, NASDAQ, Teriparatide, Patient, Osteoporosis, Vertebral column, Protein, Totally Hip Hop, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Fracture, Patent, Safety, GLOBE, Clinical trial, FDA, PTH, Biochemistry, Pharmaceutical industry, Entera, Osteocalcin

The single pivotal Phase 3 clinical trial includes a 24-month placebo-controlled duration with change in Total Hip BMD assessed as the primary endpoint.

Key Points: 
  • The single pivotal Phase 3 clinical trial includes a 24-month placebo-controlled duration with change in Total Hip BMD assessed as the primary endpoint.
  • We have agreement with FDA to continue to treat the same patient population that significantly benefited from EB613 treatment during our Phase 2 study.
  • As the first daily tablet PTH osteoanabolic treatment, we believe EB613 could significantly impact the osteoporosis treatment paradigm.
  • The Companys most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in clinical development.

Entera Bio Presents Dose Proportional Absorption and Correlation to BMD Clinical Response Data from its Phase 2 Study of EB613 in Post-Menopausal Osteoporosis Patients at the ASBMR 2022 Annual Meeting

Retrieved on: 
Monday, September 12, 2022
Osteoporosis, Tablet, Gastrointestinal tract, PTH, Woman, BMD, Blood, American Society for Bone and Mineral Research, Poster, Society, Parathyroid hormone, Oral, Menopause, Organic acid, NASDAQ, Calcium, Teriparatide, Parathyroid gland, GLOBE, R, Kidney, Plasma, Pharmaceutical industry, Medical imaging, Entera, Osteocalcin

These new analyses of blood hPTH concentration shortly after a dose of oral EB613 tablets confirm a strong, statistically significant correlation between mean blood level and the dose of EB613 taken.

Key Points: 
  • These new analyses of blood hPTH concentration shortly after a dose of oral EB613 tablets confirm a strong, statistically significant correlation between mean blood level and the dose of EB613 taken.
  • This finding is consistent with excellent correlation between change in lumbar spine BMD and dose of EB613 after 6 months of treatment, Said Dr. Arthur Santora, Chief Medical Officer at Entera.
  • We are encouraged by this important correlation analysis from our positive phase 2 study of EB613.
  • The most recent study was a dose ranging Phase 2 study in postmenopausal women with low bone mass.

Sparrow Pharmaceuticals Doses First Patient in Phase 2 Clinical Trial of SPI-62 with Prednisolone for Polymyalgia Rheumatica

Retrieved on: 
Friday, September 9, 2022
Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Cardiovascular disease, Osteocalcin, Insulin resistance, Osteoporosis, Patient, PMR, Polymyalgia rheumatica, Steroid, Dyslipidemia, Autoimmune disease, Vasculitis, Autoimmunity, Doctor of Philosophy, Toxicity, Rheumatology, Disease, Giant cell arteritis, Medication, C-reactive protein, Tissue, Pains, NCT, Glaucoma, Bruise, Endocrinology, Glucocorticoid, Skin, ACHES, Weight gain, Tissue (biology), Cortisone, Stroke, Hypertension, Aortic aneurysm, Bone loss, GCA, Myalgia, Risk, Motion, Diabetes, Insomnia, Muscle atrophy, Life, Degenerative disease, Prednisolone, Pharmaceutical industry, Dietary supplement

This trial will be the first to evaluate steroid efficacy and toxicity in patients with an autoimmune disease in the presence of a HSD-1 inhibitor.

Key Points: 
  • This trial will be the first to evaluate steroid efficacy and toxicity in patients with an autoimmune disease in the presence of a HSD-1 inhibitor.
  • If we observe separation of the desired from undesired effects of prednisolone, well be an important step closer to solving a decades-old puzzle in autoimmune disease treatment.
  • Patients with PMR taking a daily 10mg oral dose of prednisolone may be eligible for the trial.
  • To learn more about Sparrow Pharmaceuticals and its clinical trials, visit the website at www.sparrowpharma.com .

Entera Bio Provides Business Highlights and Financial Results for the Second Quarter 2022

Retrieved on: 
Thursday, August 11, 2022
FDA, Teriparatide, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Woman, Endocrinology, Gastrointestinal tract, GLOBE, R, Hypoparathyroidism, Clinical trial, Bone, Coronavirus Scientific Advisory Board (Turkey), D&O, Patent, Society, Research, FNIH, Vitamin D, Patient, Parathyroid hormone, Company, American Society for Bone and Mineral Research, Protein, Organic acid, NASDAQ, Parathyroid gland, Lists of diseases, BMD, Maintenance, Kidney, Calcium, Insurance, Type, Consultant, Food, Osteoporosis, CSAB, Disease, PTH, Pharmaceutical industry, Online gambling, Osteocalcin, Amgen, Entera

JERUSALEM, Aug. 11, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (Entera or the Company) a leader in the development of orally delivered peptides and therapeutic proteins, today announced its financial and operating results for the quarter ended June 30, 2022.

Key Points: 
  • JERUSALEM, Aug. 11, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (Entera or the Company) a leader in the development of orally delivered peptides and therapeutic proteins, today announced its financial and operating results for the quarter ended June 30, 2022.
  • Entera expects to hold a Type C Meeting with the FDA to discuss the potential registrational study for its lead clinical asset, EB613 in the second half of 2022.
  • Entera expects that the current cash is sufficient to fund the operations through the second quarter of 2023.
  • Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release.

Neoss, Inc. is celebrating the launch of NeoGenix XP™

Retrieved on: 
Monday, October 25, 2021
Research, Patient, Osteocalcin, Prosthodontics, Type I collagen, Extracellular matrix, Cell adhesion, Multimedia, Membrane, Phosphorus

WOODLAND HILLS, Calif., Oct. 25, 2021 /PRNewswire/ -- Following thesuccessful and well-received Allograft line,Neoss is excited to announce the addition of NeoGenix XP this autumn to our existing product portfolio.

Key Points: 
  • WOODLAND HILLS, Calif., Oct. 25, 2021 /PRNewswire/ -- Following thesuccessful and well-received Allograft line,Neoss is excited to announce the addition of NeoGenix XP this autumn to our existing product portfolio.
  • NeoGenix XP is a safe and clinically proven natural bone substitute, that closer resembles natural bone than those of synthetic materials, such as hydroxyapatite or tricalcium phosphate.
  • "Being a strong partner to our customers has always been important and offering more in terms of total package solutions.
  • NeoGenix XP is an important addition to this and strengthens not only the bone regeneration portfolio but will allow us to serve our customer even better!"

Entera Bio Presents Positive Phase 2 6-Month Bone Mineral Density Data for Oral PTH Formulation at Late Breaker ASBMR Conference Session

Retrieved on: 
Wednesday, October 6, 2021
BMD, Serum, Woman, Patient, Society, Therapy, NASDAQ, American Society for Bone and Mineral Research, Annual general meeting, Menopause, CTX, PTH, Osteocalcin, Oral, Spine, GLOBE, Dietary supplement, Medical imaging

BOSTON and JERUSALEM, Oct. 06, 2021 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, presented the 6-month bone mineral density (BMD) data from its completed Phase 2 clinical trial of EB613, an oral formulation of human parathyroid hormone (1-34), or PTH, for the treatment of osteoporosis. The Late Breaking Presentation “A Six-month Phase 2 Study of Oral PTH in Postmenopausal Women with Low Bone Mass – 6 Month Bone Mineral Density (BMD) Results” was selected for a prestigious oral presentation, given by Entera’s Chief Medical Officer, Dr. Arthur Santora. The oral presentation was given at 12:15 PM PDT at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in San Diego on Monday, October 4, 2021. Many scientific leaders in the field of Osteoporosis expressed great excitement with the data and the possibility of an oral osteoanabolic (bone building) agent which elderly osteoporosis patients would be willing to take.

Key Points: 
  • The Late Breaking Presentation A Six-month Phase 2 Study of Oral PTH in Postmenopausal Women with Low Bone Mass 6 Month Bone Mineral Density (BMD) Results was selected for a prestigious oral presentation, given by Enteras Chief Medical Officer, Dr. Arthur Santora.
  • Patients receiving 2.5 mg oral PTH for 6 months had a placebo-adjusted increase of 3.78% in lumbar spine (LS) BMD (p
  • The data provides an excellent foundation for our Phase 3 registration trial, which we expect to commence in 2022.
  • Entera cautions investors not to rely too heavily on the forward-looking statements Entera makes or that are made on its behalf.