Entera Bio Ltd. (ENTX)

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Entera Bio Ltd Announces Positive Topline EB613 Phase 2 Biomarker Data


https://finance.yahoo.com/news/entera-bio-ltd-announces-positive-133000303.html

Trial Met Primary Endpoint of Significant Increase in P1NP Based on Final Analysis of 3 Month Data

Final Analysis of 6-Month Data, Including Change in Bone Mineral Density, Expected in Q2:21

BOSTON and JERUSALEM, March 11, 2021 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, announced the complete 3-month bone biomarker data analysis from the ongoing Phase 2 clinical trial of EB613. EB613 is an orally delivered human parathyroid hormone (1-34), or PTH, positioned to be the first oral bone building (anabolic) product to treat osteoporosis patients. The Phase 2 clinical trial of EB613 is a 6-month, dose-ranging, placebo-controlled, study in postmenopausal female subjects with osteoporosis, or low bone mineral density (BMD), and is being conducted at four leading medical centers in Israel to evaluate the safety of EB613 and identify the best dose(s) for a potential Phase 3 registration trial.

The trial’s primary endpoint was met - the complete 3-month results from the trial showed a significant increase in the P1NP biomarker in the 2.5 mg dose group after 3 months of treatment (P <0.04) as compared to placebo. P1NP is a biomarker that indicates the rate of new bone formation and the change at 3-months is the primary endpoint in this Phase 2 trial.

Secondary endpoints in the trial comprised the effect of treatment on several additional serum bone biomarkers at 3-months including, Osteocalcin and CTX. Similar to P1NP, Osteocalcin is a biomarker for bone formation by osteoblasts, the cells that build new bone. CTX is a biomarker that indicates the rate of bone resorption by osteoclasts, the cells that remove old bone. An osteoanabolic, or bone building effect, is based on the difference in bone formation and bone resorption. An increase in P1NP or Osteocalcin, for example, associated with a smaller increase (or decrease) in CTX, usually indicates an increase in bone mass.

Similar to the increase in P1NP, a significant increase in Osteocalcin was also observed in the 2.5 mg group after 3 months (P <0.01). In line with a potential anabolic effect, a significant decrease in CTX was observed after 3 months of treatment (P <0.015). The decrease in CTX taken together with the increase in P1NP and Osteocalcin would indicate a potential positive impact on BMDand a reduced risk of fractures, which is the goal of an anabolic osteoporosis treatment.

Biomarker data from the Placebo and EB613 2.5mg dose group are summarized below:

A significant increase in P1NP from baseline versus placebo at month 3 (P <0.04) as well as significant increases at months 1 (P <0.0001) and 2 (P <0.003);

A significant increase in Osteocalcin from baseline versus placebo at month 3 (P<0.006) as well as significant increases at months 1 (P<0.0001) and 2 (P<0.0001);

A significant decrease in CTX from baseline versus placebo at month 3 (P <0.015) as well as a significant decrease at month 1 (P <0.001)

Study Medication, EB613 or placebo, was generally well tolerated through 3 months of treatment. Common adverse events resembled those known to be associated with teriparatide by subcutaneous injection including dizziness, headache, palpitations, and nausea. There were no adverse events that were severe in intensity in any treatment group and no serious drug-related adverse events. Complete safety evaluations of the fully unblinded data will be conducted with the full 6-month data analyses.

The interim analysis of the 3-month data from the first 50% (n=80) of subjects randomized demonstrated a significant increase in P1NP after one month of treatment at the 1.5 mg dose compared to placebo. The complete 3-month biomarker results now show a significant increase in P1NP at months 1 and 2 and significant increases in Osteocalcin from baseline versus placebo at months 1, 2 and 3, with the 1.5 mg dose. The complete 3-month analysis shows a significant (P<0.0001) dose response effect of EB613 (0.5, 1.0, 1.5 and 2.5 mg) on P1NP. Entera intends to submit the full dataset for publication and/or presentation at an upcoming medical conference.

“We are very pleased and highly encouraged by the complete 3-month biomarker data from this trial. When taken together with the previously reported interim BMD data, these results support a dose response in BMD. We look forward to reporting the final results, including the 6-month BMD data, from this trial in the second quarter of 2021,” stated Entera CEO Spiros Jamas. “We believe these data support ongoing business development discussions with strategic partners with interests in osteoporosis. We also believe these data and previously reported data illustrate the power of Entera’s drug delivery platform for oral dosing of large biological molecules.”

About EB613

EB613 is an orally delivered human parathyroid hormone (1-34), or PTH, drug candidate positioned as the first potential once daily, oral, bone building (anabolic) treatment for osteoporosis patients. Teriparatide for injection (marketed under the brand name Forteo®) was approved in the U.S. in 2002 for the treatment of osteoporosis in men and postmenopausal women who are at high risk for having a fracture and is taken daily via a subcutaneous injection. Entera Bio completed enrollment of a 6-month phase 2 study in postmenopausal women with osteoporosis, or low BMD evaluating multiple doses of oral EB613 (and placebo) on BMD of the spine and proximal femur (hip), and anticipates reporting top-line BMD efficacy and safety results for the trial in the second quarter of 2021.