Shares of the leading developer of orally delivered large molecule therapeutics firm Entera Bio (NASDAQ: ENTX) have been skyrocketing in early trades today. As of the writing, ENTX stock was surging 180% following news of the completion of phase-2 trial of a hormone.
What did the study results reveal?
An in depth analysis of 3-month bone biomarker data from the ongoing Phase 2 clinical trial of EB613 has been released by Entera Bio today. Highlights of the findings by the company are as follows:
- EB613 is a new orally delivered human parathyroid hormone, or PTH, which is first to reach the market for patients with osteoporosis.
- Study participants in the Phase 2 trial of EB613 were postmenopausal women with osteoporosis, or low bone mineral density, during a 6-month, dose-ranging, placebo-controlled study.
- The four Israeli leading medical centers are conducting this trial in order to determine the safety of EB613 and identify the appropriate dose for a Phase 3 registration trial.
- After 3 months of treatment, the 2.5 mg dose group demonstrated a significant increase in the P1NP biomarker when compared to placebo (P 0.04).
- The primary end point of this Phase 2 trial is the extent of bone resorption after 3 months, as measured by P1NP, a biomarker of bone formation.
- P1NP levels significantly increased after one month of treatment at the 1.5 mg dose compared to placebo in the interim analysis of the three-month data from the first 50% of subjects randomized.
- At months 1 and 2, the 1.5 mg dose has resulted in significant increases in P1NP and Osteocalcin in comparison to placebo at months 1 and 2.
- With dosages of 0.5, 1.0, 1.5 and 2.5 mg, EB613 has a significant dose response effect on P1NP over the 3-month analysis.
- Entera have plans of submitting the complete dataset to the peer-reviewed medical journals and/or expose it at a medical conference.
The latest clinical trials and previous reports illustrate Entera Bio’s (ENTX) drug delivery platform’s ability to deliver large biological molecules administered orally. Eventually, these technological advancements will translate into the growth of the ENTX stock in the coming months.