JERUSALEM and MIAMI - Entera Bio Ltd . (NASDAQ:ENTX) and OPKO Health, Inc. (NASDAQ:OPK) today announced positive preliminary results from their joint research into an orally delivered treatment for obesity and related metabolic disorders. The study focused on a long-acting oxyntomodulin (OXM) analog combined with Entera's N-Tab™ technology, aiming to create the first oral dual agonist GLP-1/glucagon peptide.
The pharmacokinetic/pharmacodynamic (PK/PD) data from in vivo studies in rodent and pig models indicated significant systemic exposure and a favorable pharmacokinetic profile for the oral OXM after a single dose. High plasma concentrations and prolonged systemic exposure were observed in the pig model, aligning with the half-life of the currently approved oral GLP-1 analog, semaglutide.
In a glucose tolerance test on rats, oral OXM significantly reduced plasma glucose levels post-glucose administration compared to a placebo. These findings support the continued development of the treatment towards Investigational New Drug (IND) application.
Entera's CEO, Miranda Toledano, expressed satisfaction with the collaboration's progress, citing the bioavailability and pharmacological data as encouraging signs for the program's future. OPKO's previous Phase 2B study with weekly injections of pegylated OXM showed significant weight loss and reductions in HbA1, triglyceride, and cholesterol levels in obese and diabetic patients.
Entera Bio, a clinical-stage company, is leveraging its proprietary technology platform to develop oral peptide therapies for various medical needs. Its pipeline includes five oral peptide programs, with expected clinical trial commencement ranging from Phase 1 to Phase 3 by 2025. Their most advanced candidate, EB613, is in preparation for a Phase 3 study for post-menopausal osteoporosis.
OPKO Health is a diversified biopharmaceutical and diagnostics company with a focus on novel technologies and large market opportunities.
The companies plan to present the full data at an upcoming clinical conference. There are currently no approved oral OXM agonists, and competitors are developing treatments requiring injections or are small molecules.
This report is based on a press release statement and contains forward-looking statements that involve risks and uncertainties. The actual future results or developments may differ materially from those projected due to various factors.
In other recent news, Entera Bio Ltd., a Jerusalem-based biotechnology firm, has made significant strides in its internal operations. The company's shareholders recently approved several key proposals during their Annual Meeting. Notably, the shareholders elected Miranda Toledano and Yonatan Malca to the company's Board of Directors for a three-year term, following an overwhelmingly positive vote.
In addition to these appointments, the shareholders approved a one-time compensation grant for CEO Miranda Toledano. The revised compensation terms for the company's non-executive directors also received approval, along with an amendment to the company's 2018 Equity Incentive Plan, which includes an increase in the number of shares issuable by 1,788,515 shares.
Lastly, the company's amended and restated compensation policy for directors and officers was ratified, as well as the compensation of the company's named executive officers on an advisory, non-binding basis. These recent developments reflect the ongoing commitment of Entera Bio's shareholders to the company's leadership and strategic direction.
InvestingPro Insights
Entera Bio Ltd. (NASDAQ:ENTX), a clinical-stage biotech company, has recently shown promising results in its collaborative research with OPKO Health. The financial landscape of Entera Bio is characterized by a market capitalization of approximately $70.11 million, indicating a relatively small but potentially agile player in the biotechnology industry. Investors should note that the company's stock has experienced significant volatility, a common trait among clinical-stage biotech companies, highlighting a risk factor for potential investors.
From a financial perspective, Entera Bio's balance sheet reflects a strategic position where cash holdings surpass debt, providing some financial flexibility as it advances its clinical programs. This could be particularly beneficial for the company as it navigates the capital-intensive phases of drug development and clinical trials. Additionally, Entera Bio does not pay dividends, which is typical for companies focused on growth and reinvesting earnings into research and development.
Despite being in the growth phase, Entera Bio is not currently profitable, with a negative P/E ratio of -7.48 and adjusted P/E ratio for the last twelve months as of Q2 2024 standing at -8.34. The company's revenue growth is impressive at 159.09% over the same period, although the absolute revenue figure remains low at $0.06 million. This indicates rapid growth from a small base, which may attract investors looking for high-growth opportunities in the biotech sector.
For readers interested in gaining deeper insights, there are 10 additional InvestingPro Tips available for Entera Bio, which could provide a more comprehensive understanding of the company's financial health and market potential. These insights are accessible through the InvestingPro platform and can be a valuable resource for making informed investment decisions.
As Entera Bio and OPKO Health continue to make strides in their joint research, these financial metrics and InvestingPro Tips serve as important considerations for investors tracking the potential market impact of their oral peptide therapies.
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