Benzinga | Aug 20, 2020 06:35AM EDT

Entera Bio Ltd Announces Interim Data From Phase 2 Clinical Trial Of EB613 In Osteoporosis



6-Month Interim Data Indicate EB 613 Has Meaningful and Positive Impact onLumbar Spine Bone Mineral Density (BMD) in a Dose Dependent Manner --

Company Expects to Complete Patient Enrollment in Q3:20 and Report InterimBiomarker Data from 2.5 mg Dose in Q1:21 with Final Data Expected in Q2:21

Company to Host Conference Call and Webcast Today at 8:30 a.m. EDT

BOSTON and JERUSALEM, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of orally delivered large molecule therapeutics, announced financial and operating results for the quarter ended June 30, 2020 as well as 6-month interim biomarker and bone mineral density (BMD) data from the first 50% of the projected enrollment in the ongoing Phase 2 clinical trial of EB613. EB613, Entera's clinical compound, is an orally delivered human parathyroid hormone (1-34), or PTH, program positioned as the first potential oral bone building product to treat osteoporosis patients.

Based on the 6-month data, EB613 generated a mean placebo adjusted increase in lumbar spine BMD of 2.15% (p = 0.08) for the 14 patients in the 1.5 mg treatment arm, as compared to 16 patients in the placebo arm. The placebo-adjusted increase was comprised of a mean BMD increase of 1.44% in the 1.5 mg treatment arm compared to a mean decrease of 0.71% in the placebo arm. An additional analysis of BMD changes in all EB613 treatment groups showed a significant dose-dependent trend in the percentage change in lumbar spine BMD. This dose response supports the use of a higher dose to potentially increase efficacy. As expected and consistent with published data from subcutaneous teriparatide, an analysis of BMD of the total femur and femoral neck did not show a significant effect from treatment with EB613. Increases in and maintenance of BMD are widely accepted by clinicians throughout the world as indicators of an overall improvement of osteoporosis and a change in lumbar spine BMD is typically accepted by the United States Food and Drug Administration as a phase 3 study efficacy endpoint for a novel oral formulation intended to treat osteoporosis using the 505 (b)(2) regulatory pathway. This is due to the fact that PTH (1-34) (teriparatide for injection) has been shown to reduce the risk of fractures.

The 6-month Placebo Adjusted Lumbar Spine BMD results are summarized below (mean, standard error):

https://www.globenewswire.com/NewsRoom/AttachmentNg/43b00428-a38a-41e8-a645-2627ad3fdd9a

"We are highly encouraged by the dose dependent improvement in lumbar spine BMD as seen in the interim data from the first half of the patients in the EB613 Phase 2 dose ranging clinical trial, especially given the small sample size of only 14 patients in the 1.5 mg treatment group. While the data reported today include favorable results from the 1.5 mg treatment arm, we believe that 1.5 mg may not be the maximum effective dose. This belief which is supported by the 3-month biomarker data we reported earlier this year, led us to amend the protocol in July to add a 2.5 mg treatment arm to the trial," stated Roger Garceau, MD, Director and Interim CEO of Entera. "Given the results we saw in the 1.5mg treatment group, we are very much looking forward to seeing the performance of the 2.5 mg treatment arm," continued Dr. Garceau.

6-Month Interim Results from Phase 2 Study of EB613 in Osteoporosis

The Phase 2 clinical trial of EB613 is a dose-ranging, placebo-controlled, study in postmenopausal female subjects with osteoporosis, or low BMD, and is being conducted at four leading medical centers in Israel. Phase 2 dose-ranging studies are utilized to determine the best dose to move into later stage clinical trials. Based on the three-month interim biochemical marker and safety data from the first 80 subjects randomized, the Phase 2 protocol was amended in July 2020 to discontinue the two lower doses (0.5 mg and 1.0 mg) and add a 2.5 mg dose of EB613. The clinical trial is currently enrolling subjects in the 2.5 mg, 1.5 mg and placebo groups, with completion of enrollment for the targeted 160 patients expected by the end of the third quarter. There are currently 131 subjects enrolled in the trial.

Of the first 80 subjects who were enrolled in the trial, 72 completed their 3-month visit and 68 completed their 6-month visit. Bone biomarker data at 6-months including P1NP, Osteocalcin and CTX were consistent with the results seen after three months of treatment at the 1.5 mg dose. There were no significant changes in any of these bone biomarkers after treatment with EB613 for 6 months, versus placebo. The demographics for the EB613 Phase 2 clinical trial such as age, BMI and baseline levels of bone markers were generally consistent with demographics from similar osteoporosis studies in the literature.