Entera Bio Announces Publication of Oral PTH(1-34) Peptide Tablets (EB613) Phase 2 Trial Data in the Journal of Bone and Mineral Research
- Successful Phase 2 Trial results of EB613 published in JBMR
- Significant gains in bone mineral density observed
- 2.5 mg dose of EB613 showed increased bone formation and decreased breakdown
- No significant safety concerns reported
- EB613 addresses the treatment gap for osteoporosis patients
- None.
The publication of Phase 2 clinical trial results for EB613 in the Journal of Bone and Mineral Research represents a significant milestone in the development of osteoporosis treatments. The primary endpoint of increased bone mineral density (BMD) and the secondary endpoint of safety profile improvement are key indicators for the potential market viability of a new drug.
Current osteoporosis treatments often involve injections, which can be a barrier to patient compliance. The introduction of an oral tablet like EB613 could significantly enhance patient adherence, thereby improving treatment outcomes. The dual action of bone formation stimulation and bone resorption reduction could position EB613 as a competitive player in the osteoporosis treatment market, which was valued at approximately $11.5 billion in 2020 and is expected to grow.
However, it is important to consider that while the results are promising, they are preliminary. Further studies, particularly Phase 3 trials, are necessary to confirm these findings and to assess long-term safety and efficacy. The market impact will also depend on the pricing strategy, insurance coverage and the ability of Entera Bio to scale production to meet potential demand.
The osteoporosis market is highly competitive, with several established players and treatments. The successful development of EB613 could disrupt this market by offering a more convenient treatment option. The shift from injections to oral administration could lead to a reevaluation of market shares among competitors, potentially benefiting Entera Bio.
Investors should monitor Entera Bio's progress towards Phase 3 trials and any partnerships or funding that may be secured to support further development. The company's stock could see volatility based on the outcomes of these trials and regulatory milestones. Moreover, the market's response to an oral osteoanabolic agent will be contingent upon the drug's cost-effectiveness and integration into existing treatment protocols.
Long-term, if EB613 is approved, it could lead to increased revenue streams for Entera Bio and possibly attract acquisition interest from larger pharmaceutical companies seeking to expand their osteoporosis portfolios.
Entera Bio's progression to Phase 2 clinical trials and the publication of results in a reputable journal is an encouraging sign for regulatory approval processes. The FDA and other regulatory bodies place significant emphasis on both efficacy and safety and the reported favorable outcomes on these fronts could facilitate a smoother path to market.
It is important to understand that the regulatory landscape for osteoporosis drugs is stringent, with a high bar set for both efficacy and safety due to the chronic nature of the disease and the population it affects. The company will need to demonstrate that EB613's benefits outweigh any risks and that it provides a clear advantage over existing treatments.
Furthermore, Entera Bio must prepare for rigorous post-marketing surveillance and potentially additional Phase 4 studies to monitor long-term effects. The ability to navigate these regulatory waters will be a determining factor in EB613's commercial success.
JERUSALEM, April 08, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides, announced today that data from the Phase 2 Trial of its lead clinical compound, EB613 (Oral PTH(1-34) Tablets) for the Treatment of Post-Menopausal Women with Low BMD or Osteoporosis compared to placebo were published in the Journal of Bone and Mineral Research (JBMR).
Miranda Toledano, CEO of Entera, commented, “We are excited to share that data from our successful Phase 2 study of EB613 has been accepted and now published in the prestigious JBMR. We believe EB613 addresses the current treatment gap in osteoporosis as the first oral, osteoanabolic (bone building) once-daily tablet treatment due to its unique format and potential dual mode of action. We remain highly committed to moving EB613 forward to meet the needs of patients.”
As reported in the Journal of Bone Mineral Research:
Despite the superior benefits of bone building (anabolic) agents and guidelines supporting their use, these medications are used in a minority of patients for whom they are appropriate, in part because they require daily or monthly injections, which limit patient acceptance.
An oral anabolic tablet has potential to address this substantial treatment gap.
In this double-blind, placebo controlled, dose-finding randomized study, 161 postmenopausal women with low bone mineral density or osteoporosis were treated with varying doses of the active part of parathyroid hormone [PTH(1-34), EB613] or placebo given in daily oral tablets for 6 months.
The highest EB613 oral PTH tablet dose (2.5 mg), produced an increase in markers of bone formation while simultaneously decreasing the markers of bone breakdown.
Significant gains in bone mineral density of the spine and hip were observed at the end of the 6-month study and there were no significant safety concerns.
The 2.5 mg oral PTH tablet dose was well tolerated when patients were instructed to titrate up to the full dose.
We conclude that this PTH tablet might be the first effective orally administered bone building medication and should be studied further in treatment of women with osteoporosis.
Reference:
Liana Tripto-Shkolnik, Auryan Szalat, Gloria Tsvetov, Vanessa Rouach, Chana Sternberg, Anke Hoppe, Gregory Burshtein, Hillel Galitzer, Miranda Toledano, Gil Harari, Arthur C Santora, Felicia Cosman, Oral daily PTH(1-34) tablets (EB613) in postmenopausal women with low BMD or osteoporosis: a randomized, placebo-controlled, six-month, phase 2 study, Journal of Bone and Mineral Research, 2024, zjae057, https://doi.org/10.1093/jbmr/zjae057
About Entera Bio
Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab™) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the into the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (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, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). 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. The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.
Cautionary Statement Regarding Forward Looking Statements
Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.
Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.
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