Entera Bio recently entered into a $270 million license agreement with Amgen

Entera Bio‘s platform technology enables oral therapies based on molecules that would otherwise undergo gastric degradation and have limited or no bioavailability. By transforming injectable drugs to oral drugs, the treatment becomes more ‘user-friendly’ which may lead to higher patient and physician acceptance and enables personalized care.

On December 11th 2018, Entera Bio announced a research collaboration and license agreement with Amgen in the area of inflammatory disease and other serious illnesses totaling up to $270 million in milestone payments as well as a mid-single digit royalty on commercial sales.

A full report on Entera Bio https://ww2.frost.com/research/equity-research/entera-bio/ was published in the framework of Frost & Sullivan’s Independent Equity Research Program and can be downloaded for free.

In September 2019, Adam Gridley became CEO of Entera Bio and Phillip Scwartz, the founder, became the president.

Entera Bio received positive feedback from the FDA regarding its 505(b)(2) regulatory pathway which saves years and money in development. Entera Bio‘s lead oral PTH product candidates are EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism.

Positive results from its pharmacokinetic (PK) and pharmacodynamic (PD) study in patients with hypoparathyroidism treated with its oral parathyroid hormone (PTH) drug [Oral hPTH(1-34)] were presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Orlando, Florida on September 22, 2019.

Entera’s previous Phase 2 study in hypoparathyroid patients presented in 2016 showed that four times daily (QID) dosing of oral hPTH (1-34) had a positive effect on serum calcium, a reduction in serum phosphate and a reduction in urinary calcium. The goal of this new PK/PD study was to compare twice-daily (BID), three times daily (TID) and QID dosing regimens and dose strengths of Entera’s Oral hPTH (1-34) over a 24-hour period.  The results showed that the largest changes in PD endpoints were found with QID dosing, with moderate changes in PD endpoints generally found with  BID and TID dosing.  In addition, the QID dosing decreased urine calcium over 24-hours, which indicates that it may be able to reduce urinary calcium in hypoparathyroid patients with hypercalciuria during long-term treatment,” stated Professor Sofia Ish-Shalom, a principal investigator at the Endocrine Research Center at Lin Medical Center in Haifa, Israel. “As investigators, we were pleased to see that Oral hPTH (1-34) had a positive impact on PD parameters, an increase in serum calcium, a decrease in serum phosphate and an increase in active vitamin D (1,25-dihycroxyvitamin D) synthesis. Importantly, these data again show the ability of Entera’s oral formulation to deliver PTH to the bloodstream at concentrations that produced the anticipated PD effect. Furthermore, this well controlled study included the highest approved dose of hPTH (1-84) (Natpar®) 100 micrograms as an active control.”

“The data from this study suggest that our Oral PTH delivered at different frequencies, and with different doses, can be used effectively to customize the therapy of individual patients. For example, some patients with elevated urinary calcium might be well served with more frequent dosing three or four times daily, while patients who have milder disease might be adequately served by less frequent twice-a-day dosing. We as clinicians find the severity of disease is a continuum that is best treated by custom titration calcium and each drug to each patient’s needs,” stated Dr. Arthur Santora, Chief Medical Officer of Entera. “Both PK and PD data from this study will be very valuable in helping optimize the formulation of Oral hPTH (1-34) for hypoparathyroidism, as well as designing long-term studies of a diverse hypoparathyroid population.  Importantly, for our ongoing dose ranging study in osteoporosis that employs a single daily dose of oral hPTH (1-34) each morning, the PK profile of the morning dose of oral hPTH (1-34) from this PK/PD study further supports our belief that the blood levels after a single daily morning dose of oral hPTH (1-34) may be sufficient to increase bone formation markers and BMD.”

About Entera Bio Ltd.

Entera Bio, a Jerusalem-based clinical-stage biopharmaceutical company, with US headquarters in Boston, was founded in 2009 by Dr. Phillip Schwartz. The Company is focused on the development and commercialization of orally delivered large molecule therapeutics for use in orphan indications and other areas with significant unmet medical needs. The Company’s technology  is being initially applied to develop an oral formulation of a human parathyroid hormone analog, Oral PTH (1-34), for treatment of hypoparathyroidism and osteoporosis.

Entera has developed a proprietary platform technology that enables oral delivery of biologicals and large molecule drugs, which are typically delivered via injections and or other non-oral pathways. However, oral drug delivery is the easiest method for self-administering medications, offers patients greater dosing flexibility, and has the highest patient acceptance and compliance rates as compared to all other routes of drug administration. The Company employs this technology for its own pipeline products and may enter into licensing agreements with biopharma companies for application of the technology to their proprietary compounds, such as the Amgen strategic research collaboration.

For more information on Entera Bio, visit www.enterabio.com.

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