Big read I know! But lots to look forward to!
$Entera Bio(ENTX.US$
EB613: First Oral PTH(1-34) Daily Osteoanabolic Tablets for Osteoporosis
EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for osteoporosis. Entera is prepared to initiate a pivotal phase 3 study in post-menopausal women with high-risk osteoporosis and no prior fracture. Entera successfully completed a phase 2, 6-month, 161-patient, placebo-controlled study. EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD in postmenopausal women with low mass or osteoporosis and no prior fracture. In October 2022, following a Type C meeting and in March 2023 following a Type D meeting, Entera announced the U.S. Food and Drug Administration’s (FDA) concurrence that a 2-year, placebo-controlled phase 3 (registrational) study with Total Hip Bone Mineral Density (BMD) as primary endpoint could support an NDA for EB613. On November 9th, 2023, Entera reported that the American Society for Bone and Mineral Research (ASBMR) announced that the SABRE (Strategy to Advance BMD as a Regulatory Endpoint) project team had submitted to its full qualification plan to FDA for the use of BMD as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs. EB613 stands as the first program to potentially avail itself of the ASBMR-SABRE BMD endpoint.
EB613: First Oral PTH(1-34) Osteoanabolic Tablets to Treat Intense Sport and Military Stress Injuries
Entera’s ability to consistently deliver its oral PTH(1-34) peptide in a simple mini tablet format with reproduceable, dose dependent pharmacokinetics and rapid biological responses across gender, age, and health status was highlighted as part of two poster sessions at the Annual Society of Bone and Mineral Research (ASBMR) 2023 Annual Meeting held on October 13-16, 2023. This work also builds the foundation for Entera’s oral PTH (1-34) tablets to potentially treat diverse patient populations including younger men and women athletes at risk of stress fractures. The Company is working towards a potential Phase 2 study for EB613 in this important indication.
EB612: First Oral PTH(1-34) Peptide Replacement Therapy Tablets for Hypoparathyroidism
EB612, is the first oral formulation of PTH (1-34), as a hormone replacement treatment for hypoparathyroidism. An open-label Phase 2a multicenter Phase 2A study, evaluating the safety, tolerability and PK of EB612 in 19 patients with hypoparathyroidism, achieved its primary and secondary endpoints, including a significant reduction in calcium supplementation (42% reduction from baseline, (p=0.001), a decline of 23% (p=0.0003) in median serum phosphate levels two hours following the first dose that was maintained for the duration of the study, improvement in quality of life score and maintenance of median calcium levels above the lower target level for hypoparathyroidism patients (>7.5 mg/dL) throughout the study. There were no treatment emergent adverse events of hypercalcemia reported and no treatment-emergent serious adverse events. Entera is currently evaluating its hypoparathyroidism program with improved formulations of EB612 based on new intellectual property, tailored to optimize its PK profile and the potential for reduced daily dosing as well as by potentially combining Entera’s platform with alternative PTH analogues. Updates from the ongoing PK/PD study are expected by the end of 2023.
First GLP-2 Peptide Tablets for Short Bowel Syndrome
Under our collaboration agreement with OPKO, OPKO will supply its proprietary long-acting GLP-2 peptide to combine with Entera’s oral peptide platform for the development of the first potential daily oral GLP-2 for the treatment of short bowel syndrome. Treatment with Glucagon-Like Peptide-2 (GLP-2) analogs has been shown to improve the absorption of nutrients in patients with short bowel syndrome (SBS) and reduce parenteral support requirements. Teduglutide, the only approved GLP-2 analog, requires daily subcutaneous injections. In SBS patients, oral drug delivery is particularly challenging because the site of absorption, the intestine, is short and less functional. Entera published pre-clinical data in May 2023 demonstrating that its oral peptide delivery platform enables gastric absorption of teduglutide, as a convenient potential tablet alternative to daily injections. OPKO and Entera expect to update on the program in the first half of 2024.
First GLP-1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity
Oxyntomodulin is a naturally occurring peptide hormone found in the colon, with glucagon-like-peptide 1 (GLP-1) and glucagon dual agonist activity which suppresses appetite and induces weight loss. OPKO has developed several proprietary, modified OXM analogs as potential candidates for treating obesity, including an injectable pegylated peptide which demonstrated significant reductions in weight loss and decreased plasma triglyceride levels with cardioprotective benefits in a 420 patient phase 2 study. Under the collaboration agreement, OPKO will supply certain OXM analogs to combine with Entera’s oral peptide platform. OPKO and Entera expect to update on the program in the first half of 2024.![]()
EB613: First Oral PTH(1-34) Daily Osteoanabolic Tablets for Osteoporosis
EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for osteoporosis. Entera is prepared to initiate a pivotal phase 3 study in post-menopausal women with high-risk osteoporosis and no prior fracture. Entera successfully completed a phase 2, 6-month, 161-patient, placebo-controlled study. EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD in postmenopausal women with low mass or osteoporosis and no prior fracture. In October 2022, following a Type C meeting and in March 2023 following a Type D meeting, Entera announced the U.S. Food and Drug Administration’s (FDA) concurrence that a 2-year, placebo-controlled phase 3 (registrational) study with Total Hip Bone Mineral Density (BMD) as primary endpoint could support an NDA for EB613. On November 9th, 2023, Entera reported that the American Society for Bone and Mineral Research (ASBMR) announced that the SABRE (Strategy to Advance BMD as a Regulatory Endpoint) project team had submitted to its full qualification plan to FDA for the use of BMD as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs. EB613 stands as the first program to potentially avail itself of the ASBMR-SABRE BMD endpoint.
EB613: First Oral PTH(1-34) Osteoanabolic Tablets to Treat Intense Sport and Military Stress Injuries
Entera’s ability to consistently deliver its oral PTH(1-34) peptide in a simple mini tablet format with reproduceable, dose dependent pharmacokinetics and rapid biological responses across gender, age, and health status was highlighted as part of two poster sessions at the Annual Society of Bone and Mineral Research (ASBMR) 2023 Annual Meeting held on October 13-16, 2023. This work also builds the foundation for Entera’s oral PTH (1-34) tablets to potentially treat diverse patient populations including younger men and women athletes at risk of stress fractures. The Company is working towards a potential Phase 2 study for EB613 in this important indication.
EB612: First Oral PTH(1-34) Peptide Replacement Therapy Tablets for Hypoparathyroidism
EB612, is the first oral formulation of PTH (1-34), as a hormone replacement treatment for hypoparathyroidism. An open-label Phase 2a multicenter Phase 2A study, evaluating the safety, tolerability and PK of EB612 in 19 patients with hypoparathyroidism, achieved its primary and secondary endpoints, including a significant reduction in calcium supplementation (42% reduction from baseline, (p=0.001), a decline of 23% (p=0.0003) in median serum phosphate levels two hours following the first dose that was maintained for the duration of the study, improvement in quality of life score and maintenance of median calcium levels above the lower target level for hypoparathyroidism patients (>7.5 mg/dL) throughout the study. There were no treatment emergent adverse events of hypercalcemia reported and no treatment-emergent serious adverse events. Entera is currently evaluating its hypoparathyroidism program with improved formulations of EB612 based on new intellectual property, tailored to optimize its PK profile and the potential for reduced daily dosing as well as by potentially combining Entera’s platform with alternative PTH analogues. Updates from the ongoing PK/PD study are expected by the end of 2023.
First GLP-2 Peptide Tablets for Short Bowel Syndrome
Under our collaboration agreement with OPKO, OPKO will supply its proprietary long-acting GLP-2 peptide to combine with Entera’s oral peptide platform for the development of the first potential daily oral GLP-2 for the treatment of short bowel syndrome. Treatment with Glucagon-Like Peptide-2 (GLP-2) analogs has been shown to improve the absorption of nutrients in patients with short bowel syndrome (SBS) and reduce parenteral support requirements. Teduglutide, the only approved GLP-2 analog, requires daily subcutaneous injections. In SBS patients, oral drug delivery is particularly challenging because the site of absorption, the intestine, is short and less functional. Entera published pre-clinical data in May 2023 demonstrating that its oral peptide delivery platform enables gastric absorption of teduglutide, as a convenient potential tablet alternative to daily injections. OPKO and Entera expect to update on the program in the first half of 2024.
First GLP-1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity
Oxyntomodulin is a naturally occurring peptide hormone found in the colon, with glucagon-like-peptide 1 (GLP-1) and glucagon dual agonist activity which suppresses appetite and induces weight loss. OPKO has developed several proprietary, modified OXM analogs as potential candidates for treating obesity, including an injectable pegylated peptide which demonstrated significant reductions in weight loss and decreased plasma triglyceride levels with cardioprotective benefits in a 420 patient phase 2 study. Under the collaboration agreement, OPKO will supply certain OXM analogs to combine with Entera’s oral peptide platform. OPKO and Entera expect to update on the program in the first half of 2024.
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