Entera Bio ( NASDAQ: ENTX ) appointed its CFO Miranda Toledano as its CEO, effective July 15, replacing Spiros Jamas.
In May, Toledano was appointed as CFO, chief business officer and head of Corporate Strategy. Toledano has served as a board member since 2018.
In addition, Entera said that the U.S. Food and Drug Administration (FDA) agreed to a Type C meeting, which is expected to happen in H2, based on a revised phase 3 study for the company's lead clinical asset EB613 (oral formulation of PTH (1-34, teriparatide) to treat post-menopausal women with osteoporosis.
Entera noted that it had submitted to the FDA, as part of its Type C briefing documents, a revised phase 3 protocol after the agency suggested the company to explore the FNIH BQP STEs and the design of a placebo-controlled study as an alternative to the originally planned non-inferiority design versus Eli Lilly's Forteo (teriparatide).
The company said in the study, patients will now receive EB613 (N=400) 2.5mg dose of oral PTH or placebo (N=200).
The main goal of the trial is to evaluate the effect of daily oral EB613 on percent change in Total Hip BMD over 18 months versus placebo.
"We are appreciative of FDA’s inputs and believe that the current Phase 3 design is a much de-risked pivotal study pathway and enables us to continue to study a similar patient population, based on T-Score and other criteria, as in our Phase 2 dose ranging study which met its 3-month biomarker and 6-month BMD endpoints," said Toledano.
ENTX +12.86% to $1.58 premarket July 18
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Entera stock rises 12% amid CFO taking charge as CFO, getting FDA meeting for lead drug