Entera Bio Ltd (NASDAQ: ENTX) has announced the concluding 6-month bone mineral density (BMD) consequences from the finished Phase 2 clinical trial of EB613 to cure osteoporosis. EB613 is an oral preparation of human parathyroid hormone (1-34), or PTH, sited to be the first oral bone-building product to treat osteoporosis patients.
Presently less than 5% of osteoporosis patients are treated with an injectable anabolic agent
Presently, less than 5% of osteoporosis patients on any form of treatment are treated with an injectable anabolic agent, extensively acknowledged as the most operative form of treatment1. The Phase 2 scientific pilot of EB613 was a 6-month dual blind study in 161 postmenopausal female subjects with osteoporosis or low bone mineral density (BMD).
The company steered the study at four leading medical centers in Israel to assess the security and effectiveness of variable doses of EB613. All lab examinations, including biomarkers and security monitoring, were done at a certified central laboratory and examined BMD statistics from scientific sites at an autonomous specialized worldwide imaging center.
The most significant BMD endpoint — alteration in the lumbar spine (LS) BMD after six months — was encountered. There were statistically meaningful dose-related tendencies in the upsurges in LS BMD and femoral neck and total hip BMD. Dose-dependent upsurges in biochemical markers of bone development were formerly reported.
A noteworthy upsurge in the lumbar spine (LS) BMD was perceived
A significant upsurge in the lumbar spine (LS) BMD was perceived in the 1.5 mg cluster, the non-titrated 2.5 mg cluster, and the titrated 2.5 mg cluster. An upsurge in LS BMD is the principal endpoint for the 505(b) (2) trail as was defined by the FDA in Entera’s pre-IND conference.
At present, it is supposed that the solitary Phase 3 Pivotal study essential under the 505b2 path would require a 12-month head-to-head revision against Forteo®, intended to realize non-dependency for the upsurge in BMD of the lumbar spine.
Upsurges in LS BMD versus placebo perceived at six months preceding Forteo® studies directed with similar patient inhabitants were in the 3.9% range.