25 Jun Entera Bio: A Game Changer in Osteoporosis in the offing!
Entera Bio Ltd. (NASDAQ: ENTX), a clinical-stage biotechnology company, developing leading-edge orally delivered large molecule therapeutics, announced pivotal 6-month bone mineral density (BMD) results from the Phase 2 clinical trial of EB613, intended for the treatment of osteoporosis. EB613, the Company’s lead candidate for the treatment of osteoporosis, and an oral formulation of human parathyroid hormone (1-34), or PTH is on track to become a first-in-class anabolic product, which is the most effective treatment for osteoporosis, however currently lower than 5 percent of the patients undergo treatment with injectable anabolic agents.
Spiros Jamas, CEO of Entera Bio, commented,
“We are very excited and encouraged by these great results which will support advancing discussions with potential strategic partners. These results are in line with our previously reported biomarker results and further validate Entera’s platform technology and its potential to enable oral formulation of various large molecules for a range of indications that could benefit from an oral drug. We are looking forward to an end of Phase 2 meeting with the FDA. More detailed results will also be presented in a future scientific conference and publications. The company will evaluate potential additional osteoporosis market opportunities specifically related to increases in hip BMD.”
The final results from a 6-month double blind, dose-ranging, placebo-controlled study, which had enrolled 161 postmenopausal female subjects with osteoporosis or low bone mineral density (BMD), was held at four leading medical centers in Israel. The primary endpoint of the study was change in lumbar spine (LS) BMD after 6 months, which was successfully met. There were significant dose-dependent increases in LS BMD, besides femoral neck and total hip BMD, especially in patients treated with EB613 2.5 mg.
An increase in LS BMD will enable the Company to apply for the 505(b)(2) pathway, as per its discussion with the FDA during the pre-IND meeting. In addition, Entera will have to conduct a single Phase 3 Pivotal study to undertake a 12-month head-to-head study against Eli Lilly’s Forteo® (teriparatide injection), a recombinant human parathyroid hormone analog (PTH 1-34).
The candidate has significant effect on both femoral neck and total hip BMD at 6 months, which are not observed in treatment with Forteo® for the same time period, which in turn correlate with reduced non-vertebral fracture risk. There was also a significant increase in the P1NP biomarker in the 2.5 mg dose group after 3 months, a biomarker which evaluates the rate of new bone formation.
In addition, the candidate was found to be generally well-tolerated, with minimal adverse events and no serious drug-related adverse events.
Entera Bio Ltd. (NASDAQ: ENTX)
Market Cap: $145.28M; Current Share Price: 6.11 USD
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Industry
Osteoporosis is a medical condition in which hormonal changes such as drop in estrogen levels, tissue loss or deficiency of calcium and vitamin D, cause the bones to become brittle and weak. The condition makes a person more susceptible to fractures of the hip, wrist and spine. Osteoporosis occurs when the body is unable to keep up with the loss of old bones and the creation of new bones is hampered.
The disease affects men and women equally, however Asian and white women who are past menopause are the highest risk. There is currently no cure for the disease, but certain medications, exercising and a healthy diet can preserve bones from degeneration and strengthen them.
Though the disease manifests quite late, with no major symptoms in the early stages, some of the signs of the onset of the disease include back pain, height reduction, postural changes and fragile bones that break easily. Some of the risk factors for developing this condition are gender, old age, race, family history and people with smaller body frames. Other risk factors include lower estrogen levels in women and testosterone levels in men, excessive thyroid hormone and overactive parathyroid and adrenal glands.
Furthermore, dietary factors such as a low -calcium diet, eating disorders, use of steroids and those with pre-existing conditions such as celiac disease, kidney disorders, cancer and Rheumatoid arthritis and most importantly poor lifestyle choices can increase the risk of osteoporosis. The disease affects more than 200 million people globally with 1 in 3 women over the age of 50 years and 1 in 5 men suffering osteoporotic fractures in their lifetime as per an estimate by the International Osteoporosis Foundation.
According to a report by Fortune Business Insights, the global osteoporosis treatment market size will reach USD 15.08 billion by 2026, growing at a CAGR of 4.3 percent, from USD 10.74 billion in 2018. A rising geriatric population, increased research and development activities, improved diagnostics and better medical coverage are driving the growth in the market. However, lack of patient compliance due to side-effects associated with osteoporosis drugs may hamper the growth in the market.
Company
Entera Bio is leveraging an innovative technology platform to orally deliver large molecules and biologics, while improving their absorption in the GI tract. The technology addresses two major issues that plague the delivery of large molecule APIs (active pharmaceutical ingredients), which is poor absorption and rapid degradation by the enzymes and acids in the gastrointestinal tract.
Entera Bio’s lead candidate is an active component of the parathyroid hormone, Teriparatide (PTH 1-34), an active pharmaceutical ingredient that is currently available in the injectable form, which is now being developed orally by the Company. The candidate is being developed for the treatment of three therapeutic areas namely hypoparathyroidism, osteoporosis, and bone healing, by making minor modifications to the formulation and dosing regimen.
The Company is adopting the oral drug delivery route to capitalize on the emergence of treatment approaches that use large molecules, peptides and proteins for treatment of various diseases. The adoption of the oral delivery route improves patient adherence and physician acceptance. This also leads to more flexibility in terms of number of doses and quantity of each dose among others.
Entera’s proprietary technology combines a synthetic absorption enhancer to improve the absorption of large molecules and prevent enzymatic degradation through use of protease inhibitors.
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In addition, the Company’s pipeline consists of EB612 PTH 1-34, intended for the treatment of Hypoparathyroidism. The company received an orphan drug designation for the candidate in April 2014 and a positive opinion from the European Medicines Agency, along with a recognition from the European Commission (EC), as an Orphan Medicinal Product. The candidate has successfully completed a phase II clinical trial in Israel, which met its primary endpoint and the results were at par with commercially available injections.
Key Takeaways
According to the National Osteoporosis Foundation (NOF), over 8 million people already have osteoporosis in the U.S alone, and an additional 44 million may be having low bone density, which puts them at high risk for developing the disease. The number of fractures caused by osteoporosis will rise to three million by 2025 leading to an estimated $25.3 billion in costs and a much higher hospitalization burden when compared to myocardial infarction, strokes and even breast cancer.
PTH (teriparatide) is the current choice of treatment for this disease, however the prohibitive costs, lack of dosing flexibility and the rigmarole of a daily injection, affects patient adherence. The Company’s oral delivery approach addresses these problems and may lead to better adherence and greater physician adoption, even in the early stages of the disease.
The Company has built a robust intellectual property rights portfolio and recently announced the grant of a patent from the European Patent Office covering the Company’s oral PTH formulations that are currently being evaluated in osteoporosis and hypoparathyroidism. Entera has built a strong portfolio in countries such as the USA, China, Japan, Australia, New Zealand and Israel.
Entera plans to initiate a phase 3 trial in Osteoporosis in 2022 and will be meeting with the FDA to discuss the design of the Phase 3 non-inferiority trial as well confirm the possibility of an approval under the 505 (b)(2) regulatory pathway. In addition, the Company intends to initiate a Phase 2b HypoPT trial in 2022.
The Company has initiated a research program to study the possibility of development of an oral glucagon-like peptide-2 (GLP-2) analog and an Oral Human Growth Hormone (hGH) Formulation for treatment of gastrointestinal and metabolic diseases and growth hormone deficiency. Entera is actively seeking industry partnerships to advance this program.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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References
https://www.fortunebusinessinsights.com/industry-reports/osteoporosis-treatment-market-101034
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