September 2026 • PharmaTimes Magazine • 8
// CLINICAL TRIALS //
Entera Bio has announced that post hoc findings from its phase 2 trial of EB613, an oral PTH(1-34) tablet, have been chosen for two presentations at the ASBMR 2026 annual meeting in Boston.
The data includes a plenary poster, one of the highest-ranked categories selected by the ASBMR committee.
EB613 is in development as the first oral anabolic tablet for osteoporosis. The phase 2 study enrolled 161 postmenopausal women with low bone mass or osteoporosis and randomised them to placebo or four EB613 dose levels for six months.
Entera plans a single, randomised, double-blind, placebo-controlled phase 3 trial involving around 750 postmenopausal women to support a potential New Drug Application. A post hoc sensitivity analysis examined how baseline T-score severity influenced EB613’s effects on bone mineral density and bone turnover markers at six months.
Tripto-Shkolnik explained: “EB613 produced rapid dose-proportional increases in biochemical markers of bone formation and reductions in markers of bone resorption.”
He added: “The effects on trabecular and cortical bone suggest that bone strengthening and fracture resistance may occur rapidly with EB613.”
The company noted that EB613 increased lumbar spine, total hip and femoral neck BMD, with 3D-DXA analysis showing improvements in integral volumetric BMD, trabecular volumetric BMD, cortical thickness and cortical surface BMD.
Oblenio has begun dosing patients in its phase 1a first-in-human trial of LBL-051, a tri-specific T cell engager designed to deplete both B cells and plasma cells in refractory autoimmune diseases.
The company said the therapy aims to deliver a durable immune system reset with the potential for sustained drug-free remission.
The open-label, multicentre study is enrolling patients across multiple autoimmune indications and uses subcutaneous dosing to assess safety, tolerability, clinical response, B cell and plasma cell depletion and selected biomarkers.
Ricardo Grieshaber-Bouyer, Professor of Clinical Systems Immunology and Head of the Clinical Trial Unit at FAU Erlangen-Nürnberg and Principal Investigator, said: “LBL-051 preclinical data have shown complete depletion of both B and plasma cells through dual targeting of CD19 and BCMA, with minimal cytokine release.
“These data support LBL-051’s potential to achieve full B lineage immune reset consistently, which may outperform the results from approaches using a single B cell target.”
He added: “The Paul Ehrlich Institute (PEI) has allowed us to pioneer a highly innovative, first-in-human, dose escalation trial design which enables rapid and thoughtful evaluation of this off-the-shelf therapeutic approach, while prioritising patient safety, in a range of autoimmune diseases.”