Entera Bio reports positive phase 2 results for osteoporosis treatment

JERUSALEM - Entera Bio Ltd. (NASDAQ: ENTX), a biotechnology firm specializing in oral peptide therapies with a current market capitalization of $79 million, has released findings from a recent Phase 2 study of its EB613 oral treatment for osteoporosis. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet. The study, which involved 161 postmenopausal women with low bone mass, showed that EB613 led to significant bone density improvements compared to placebo.

During the six-month trial, participants received either a placebo or one of four different doses of EB613. The results indicated notable increases in bone mineral density (BMD) at various skeletal sites. A post-hoc analysis using 3D-DXA technology, which provides detailed assessments of bone structure, revealed that EB613 treatment resulted in gains in integral volumetric BMD, trabecular volumetric BMD, cortical thickness, and cortical surface BMD. Analysts are optimistic about the company’s prospects, setting a price target of $10 per share, significantly above the current trading price of $1.74.

Dr. Rachel B Wagman presented the findings at the 2025 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases in Rome. She highlighted the broad distribution of bone gain observed in patients treated with EB613. These results have paved the way for a forthcoming Phase 3 trial aimed at further evaluating the safety and efficacy of the drug.

Entera Bio’s CEO, Miranda Toledano, expressed confidence in the potential of EB613 as an oral alternative to current injectable treatments for osteoporosis. Toledano noted that the therapy could address a significant treatment gap for postmenopausal women at high risk of fractures.

Osteoporosis affects a large portion of the aging population, with an estimated 50 percent of women and 20 percent of men over 50 at risk for fragility fractures. Entera Bio’s development of EB613 as a once-daily oral tablet is intended to offer a more accessible treatment option for managing bone health.

The company’s proprietary technology, N-Tab™, underpins a pipeline of oral peptide programs, including EB613. While InvestingPro analysis indicates the company isn’t currently profitable, analysts forecast significant sales growth in the coming year. Entera Bio is preparing to initiate a Phase 3 registrational study for EB613, following the FDA’s qualification of a quantitative BMD endpoint. Investors can access 5 additional exclusive ProTips and comprehensive financial analysis through an InvestingPro subscription.

This announcement is based on a press release statement from Entera Bio Ltd. and reflects the company’s ongoing efforts to innovate in the field of osteoporosis treatment. The company’s next earnings report is scheduled for May 9, 2025, which could provide additional insights into the development program’s progress and financial implications.

In other recent news, OPKO Health, Inc. and Entera Bio Ltd. have announced a collaboration to develop an oral treatment for obesity and other metabolic disorders. The companies plan to move forward with clinical trials using an oral dual agonist GLP-1/glucagon peptide, which is designed as a once-daily tablet for patients with obesity, metabolic, and fibrotic disorders. The treatment combines OPKO’s oxyntomodulin analog with Entera’s N-Tab™ technology, showing promising pharmacodynamic, pharmacokinetic, and bioavailability data from recent in vivo studies. Under the agreement, OPKO and Entera will hold 60% and 40% ownership interests, respectively, and will share development costs accordingly. OPKO has also acquired 3,685,226 ordinary shares of Entera at $2.17 per share, with proceeds funding Entera’s share of costs through Phase 1 of the development program. After Phase 1, Entera can choose to continue funding its share to maintain its ownership interest or opt out, retaining a 15% interest while OPKO assumes 85% ownership. This partnership aims to advance oral peptide therapies, as no approved dual GLP-1/glucagon agonists are currently available.

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