Entera Bio Ltd.

On World Menopause Day, we want to highlight the gap in information about the transition women will face as they age. Nearly 1 in 3 women will have their menopause symptoms misdiagnosed making this time in their lives difficult and confusing. Common symptoms include hot flashes, mood changes and sleeping disturbances, just to name a few. Importantly, osteoporosis is most frequently associated with menopause in women, where 1 in 3 women will develop osteoporosis after the age of 50. Maintaining a healthy lifestyle through weight, diet and exercise are important to an individual’s overall bone health. Entera is developing EB613, first osteoanabolic (bone building), mini-tablet treatment of PTH (1-34) dedicated to post-menopausal women with osteoporosis. #menopause #osteoporosis #worldmenopauseday

Bone mineral density (BMD) T-Score is a marker used to categorize and diagnose #osteoporosis. Normal bone density is between -1.0 and 1.0 and high risk osteoporosis is categorized by a T-score between -2.5 and -3.0. Change in #BMD has been proposed as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs. A decision by the FDA will be announced in January 2025. Entera's EB613, an oral PTH (1-34), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis. Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint, which is expected to occur by January 2025. #bonedensity #bonemineraldensity

A report by the Congressional Budget Office of the US. Congress looks at the possible effects of #Medicare covering #antiobesity medications (AOMs), such as #GLP1s like #Ozempic. More than 65% of those covered by Medicare are classified as overweight or obese, with the biggest spend coming from covering those with BMI>40. Full report can be read here: https://lnkd.in/ds8U79Rp Entera has an ongoing collaborative research program focused on developing the first oral dual agonist GLP-1/glucagon peptide as a potential once-daily treatment for patients with obesity, metabolic and fibrotic disorders.

Leading up to World Osteoporosis Day on October 20th, it is important to understand the risk factors of this silent, but deadly disease. Osteoporosis predominantly affects women, where 1 in 3 women will develop it, and 1 in 5 men, after the age of 50. Though some risk factors, like age, genetics and family history cannot be avoided, certain lifestyle factors can. Maintaining a healthy lifestyle through weight, diet and exercise are important to an individuals’ overall bone health. Entera's lead clinical candidate, EB613, is being developed as the first osteoanabolic (bone building), mini-tablet treatment of PTH (1-34) dedicated to post-menopausal women with osteoporosis. #osteo #osteoporosis #bonehealth #protectyourbones #OsteoporosisDay

The STOP Obesity Alliance partnered with the Obesity Action Coalition to analyze how states are covering the treatment of obesity in their Medicaid programs. The review of Medicaid coverage included obesity care such as: -nutrition counseling (NC) -intensive behavioral therapy (IBT) -obesity medications (OM) -metabolic and bariatric surgery (MBS) See what Medicare covers in your state here: https://lnkd.in/ectQygWz

@drlouisenewson published a comprehensive report for Menopause Awareness Month outlining the management of pre-menopausal or menopausal symptoms and treatments. #menopause #menopauseawarenessmonth

Many Gen Xers demand menopause hormone drugs, and they won’t take no for an answer. Osteoporosis is most frequently associated with menopause in women. Entera’s initial product candidates combine our oral drug delivery technology, N-Tab™, with PTH, a hormone that has been used in injectable form for many years for the treatment of osteoporosis and #hypoparathyroidism. The Company’s lead candidate EB613 has plans of being advanced into Phase 3 for the treatment of post-menopausal women with low bone mass and #osteoporosis. https://lnkd.in/eTWPYUsX

Short bowel syndrome (#SBS) is a rare and potentially life-threatening disease that develops when the small intestine does not adequately absorb essential nutrients to maintain health. GLP-2 analogs are often prescribed to help increase nutrient absorption in the intestines, however, the daily subcutaneous injections are inconvenient and expensive. To date, Gattex® (teduglutide), is the only approved GLP-2 therapy for the treatment of #shortbowelsyndrome. In March 2024, Entera announced positive in-vivo PK results from its program combining partner OPKO’s long acting GLP-2 analogue with Entera’s N-Tab™ technology. Plasma levels achieved with the oral tablet form of the GLP-2 analogue were about 10-fold higher than therapeutic plasma concentrations reported for subcutaneously administered teduglutide (Gattex®). 

Mid-late-stage osteoporosis clinical trials are mostly of generics and biosimilar programs of existing drugs. One of the main explanations for this lack of innovation in #osteoporosis is the FDA’s requirement for fracture reduction as a primary endpoint for registrational trials. These studies are large, long and expensive. In March 2024, the #FDA disclosed that a ruling to qualify bone mineral density (BMD) as a surrogate endpoint would be provided by January 2025. This decision could be the inflection point in osteoporosis clinical trial development and innovation. Entera’s EB613, a daily tablet for the treatment of osteoporosis, has its phase 3 study designed to meet the BMD thresholds proposed.

The global impact of #osteoporosis and fragility fractures is staggering. Download the infographic (available in 6 languages) to learn more about the growing burden of a disease that suffers from underdiagnosis and undertreatment worldwide. This #WorldOsteoporosisDay, coming up on October 20th, urge your local health authorities to prioritize bone health and fracture prevention! https://bit.ly/3z1hSoX