Entera Bio Ltd. (NASDAQ: ENTX) has released its financial results for the third quarter of 2024, alongside key business updates highlighting advancements in its oral peptide and small therapeutic protein programs. The company is focused on developing oral alternatives to injectable peptide therapies, addressing unmet needs in osteoporosis, obesity, short bowel syndrome, and hypoparathyroidism.
EB613 for Osteoporosis
EB613, Entera's lead product candidate, is an oral parathyroid hormone (PTH(1-34)) tablet designed for post-menopausal women at high risk of osteoporosis. New comparative pharmacological data for EB613 were presented at the American Society for Bone Mineral Research (ASBMR) 2024 Annual Meeting. According to Entera's CEO Miranda Toledano, the company anticipates the FDA's decision on the ASBMR-FNIH SABRE regulatory endpoint for osteoporosis drugs in January 2025, which could accelerate the approval pathway for EB613 by using total hip Bone Mineral Density (BMD) as a surrogate endpoint correlated to fracture outcomes.
Toledano emphasized the need for new treatments for osteoporosis, particularly oral anabolic therapies, to address the significant treatment gap in women's health. Despite available injectable anabolic treatments, their use remains limited. EB613 aims to provide a more accessible and convenient oral option.
Oral GLP-1/Glucagon Agonist for Obesity
Entera Bio, in collaboration with OPKO Health, Inc., announced topline pharmacokinetic/pharmacodynamic (PK/PD) results for their oral oxyntomodulin (OXM) tablet program. This program is developing a once-daily oral dual agonist GLP-1/glucagon peptide for obesity and metabolic disorders, utilizing Entera’s proprietary N-Tab™ platform. The oral OXM demonstrated significant systemic exposure, a favorable PK profile, and bioavailability comparable to semaglutide (Rybelsus®). Additionally, it showed a statistically significant reduction in plasma glucose levels compared to placebo. The data will be presented at an upcoming clinical conference.
Oral GLP-2 for Short Bowel Syndrome and EB612 for Hypoparathyroidism
Entera is also progressing with the pre-IND validation of its oral GLP-2 tablet for Short Bowel Syndrome in partnership with OPKO. Final in vivo PK/PD data is expected in the second half of 2024. This program aims to provide an oral alternative to injectable GLP-2 replacement therapy for patients with this rare intestinal failure condition. Furthermore, Entera continues to collaborate with a third party on the development of EB612, an oral PTH replacement treatment for hypoparathyroidism.
Financial Update
As of September 30, 2024, Entera Bio reported cash and cash equivalents of $6.9 million, which are expected to fund operations into the third quarter of 2025. Research and development expenses for the quarter were $1.5 million, compared to $1.4 million in the same period of 2023. General and administrative expenses increased to $1.5 million from $1.0 million year-over-year, primarily due to increased intellectual property expenses and consultancy fees. The net loss for the quarter was $3.0 million, or $0.08 per ordinary share.
