Entera Bio Touts EB613 Oral Anabolic Tablet as Osteoporosis Care Gap Persists, Phase III Near

Key Points

• Entera Bio’s EB613 is an oral anabolic tablet aimed to "democratize anabolic therapy" for osteoporosis and the company says a Phase III program — testing EB613 as up to 12–24 months monotherapy and in sequence with an antiresorptive — will start imminently.
• Phase II data reportedly showed EB613 increases bone mineral density at six months comparable to injectable PTH at hip and spine and exhibits a tissue-level dual effect of stimulating bone formation while suppressing breakdown.
• Physicians reported a significant treatment gap driven by injectable-only anabolics: only 12% currently use injectable anabolics while 92% said they would treat with an oral anabolic if available, suggesting strong potential uptake.

Entera Bio NASDAQ: ENTX executives and physician panelists used a roundtable discussion to highlight what they described as persistent gaps in osteoporosis care and the potential role for the company’s lead candidate, EB613, which it is developing as an oral anabolic (bone-forming) tablet.

Miranda Toledano, Entera Bio’s CEO, said the company’s goal with EB613 is to “democratize anabolic therapy” by offering a tablet alternative to currently available anabolic treatments, which require injections. She positioned osteoporosis as a disease where limitations in “uptake, accessibility, and acceptability” have constrained use of anabolic therapies, despite their clinical potential.

Physicians cite treatment gap tied to injectable-only anabolics

Steve Goldstein, a professor of obstetrics and gynecology at NYU Grossman School of Medicine, said OB-GYNs often act as the primary point of care for bone health for women transitioning through menopause. He shared results from a gynecologist survey he said was conducted recently, noting that while most respondents reported they order DXA scans and treat osteoporosis with established oral antiresorptives, far fewer use injectable anabolics.

Goldstein said the survey showed:

• 92% of gynecologists were ordering DXA scans
• 64% were treating patients with osteoporosis
• More than 90% used alendronate (Fosamax), with significant use of risedronate (Actonel), raloxifene (Evista), and denosumab (Prolia)
• Only 12% were using injectable anabolic agents
• 92% said they would treat with an oral anabolic agent if one were available

Goldstein argued that the need to refer patients to endocrinologists or rheumatologists for anabolic therapy creates another point where patients “fall through the cracks,” citing missed appointments and reluctance to begin injectable therapy.

Felicia Cosman, an osteoporosis specialist participating in the discussion, said the “proof” of the treatment gap can be seen in the volume and impact of fractures, citing approximately two million fractures per year due to osteoporosis “at least in part,” with consequences for quality of life and mortality. Goldstein added that he discusses mortality following hip fracture with patients, saying 21% die within a year and 25% can end up in a nursing home.

Anabolic-first sequencing gaining attention

Panelists contrasted anabolic therapies, which build bone, with antiresorptives, which slow bone loss associated with remodeling. Cosman said anabolic medication can generate “larger and faster increases in bone density” and can repair microstructural defects that contribute to fragility and fracture risk. However, she said the need for daily self-injection or monthly in-office injection for current anabolic options remains a “significant” barrier for both providers and patients.

Goldstein said clinical practice is shifting from an approach that starts with antiresorptives and reserves anabolics for more severe cases toward “an anabolic first” strategy—building bone and then maintaining gains with an antiresorptive. Cosman echoed that sequencing concept, saying anabolic agents are more effective when used as initial therapy, with the aim of moving patients out of the osteoporosis range and then maintaining improvements.

EB613 positioned as an oral option using a known mechanism

Toledano said Entera Bio has worked to understand where osteoporosis is being treated—describing management across gynecology, primary care, and specialist settings—and argued that many patients do not reach specialist offices. She also said Entera sees conservative prescribing patterns globally, with most women receiving bisphosphonates.

Toledano further said the company’s approach is not to “reinvent the wheel,” describing EB613 as a tablet form of a therapy based on a “well-known mechanism of action” and referencing a drug with “24 years” of approval history. She also cited a feasibility study involving more than 400 potential investigators across 22 countries, saying clinicians were familiar with Forteo and teriparatide and had decades of experience with those therapies.

Goldstein said an oral anabolic could be more acceptable to patients who are earlier in the menopausal transition and may be reluctant to treat a “silent disease” until a DXA T-score or FRAX score motivates action. He also noted rising public awareness, including the National Osteoporosis Foundation’s name change to the Bone Health & Osteoporosis Foundation.

Phase II takeaways and phase III goals described

Cosman discussed EB613’s phase II results in general terms, saying the data show EB613 stimulates bone formation while also suppressing bone breakdown, which she described as a dual mechanism at the tissue level. She said bone mineral density (BMD) increases observed at six months were comparable to those seen with injectable PTH at both hip and spine sites, and she linked early BMD changes to improvements in bone strength and quicker reductions in fracture risk.

Looking ahead, Cosman said acceptance could be aided by the familiarity of physicians and patients with daily oral medications versus injectables, and she reiterated that anabolic therapies need to be followed by an antiresorptive to maintain gains.

In closing remarks, Toledano said Entera intends to move into a phase III program “imminently” and said the trial is designed to answer how EB613 performs as monotherapy for up to 12 or 24 months and how it performs in sequence with an antiresorptive drug. She framed the objective as enabling more patients to take a viable anabolic therapy in a format they may be willing to use, with the aim of deterring fractures and downstream complications.

About Entera Bio NASDAQ: ENTX

Entera Bio, Inc is a clinical‐stage biopharmaceutical company pioneering the development of orally delivered peptide therapeutics. Utilizing its proprietary oral delivery platform, Entera Bio seeks to overcome the challenges of gastrointestinal absorption for large peptide molecules. The technology is designed to facilitate transit across the intestinal epithelium while preserving peptide structure and bioactivity, offering the potential for daily oral dosing in lieu of injectable formulations.

The company's lead candidate, EB613, is an oral parathyroid hormone (PTH) analog under investigation for the treatment of osteoporosis.

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