Entera Bio (ENTX) Oppenheimer 35th Annual Healthcare Life Sciences Conference (Virtual) 2025 summary

Company overview and technology

• Focuses on developing oral peptide therapeutics in mini-tablet formats for gynecology, endocrinology, GI, and metabolic diseases.

• Lead candidate EB613 is the first PTH(1-34) osteoanabolic bone-forming tablet for postmenopausal osteoporosis.

• NTAB technology stabilizes peptides in the GI tract and enhances absorption via SNAC.

• Pipeline includes programs for hypoparathyroidism (EB612), metabolic, and GI diseases, some in partnership with OPCO.

• All programs aim for once-daily oral dosing.

Clinical development and data

• EB613 phase three initiation planned for the second half of 2025, pending FDA endpoint qualification.

• Phase two study in postmenopausal women showed dual mechanism: increased bone formation and mild suppression of bone resorption.

• EB613 demonstrated rapid and significant increases in total hip bone mineral density at six months, outperforming injectable comparators.

• Safety profile includes expected PTH agonist effects, mitigated by dose titration.

• Phase three will target high-risk postmenopausal women with fragility fractures but no major fractures.

Regulatory and industry context

• FDA, in collaboration with the SABRE group, is considering BMD as a surrogate endpoint for osteoporosis drug approval.

• SABRE meta-analysis of 173,000 patients found total hip BMD most closely linked to fracture risk reduction.

• EB613 phase three is designed to meet SABRE’s quantitative BMD thresholds.

• Final FDA determination on the endpoint is expected within 10 months from March 2024.

• Company is in ongoing discussions with FDA and SABRE, expecting updates this quarter.