OPKO Health (OPK) And Entera Bio Announce Data for GLP-2
OPK Health, Inc. OPK and Entera Bio Ltd. ENTX recently announced the positive pharmacokinetic outcomes from their joint study that combines Entera's exclusive N-Tab technology with a long-acting, proprietary GLP-2 agonist created by OPK.
The program's primary objective is to create the first and only GLP-2 peptide pill substitute for individuals with short bowel syndrome (SBS) and other conditions that cause inflammation of the mucosa and loss of nutrients.
More on Short Bowel Syndrome
SBS is a rare and potentially life-threatening malabsorptive condition caused by a significant loss of functional bowel mass or physical bowel mass. SBS patients have a reduced ability to absorb nutrients and fluids and are at risk of malnutrition, unintended weight loss and additional symptoms due to the loss of essential vitamins and minerals.
More on the Study
The program's primary goal is to create the first and only GLP-2 peptide pill substitute for individuals with short bowel syndrome and other conditions characterized by inflammation of the mucosa and loss of nutrients. The only GLP-2 agonist that is currently licensed for use is Takeda Pharmaceuticals’ TAK GATTEX (teduglutide), and it is administered subcutaneously once a day.
As the first validation for oral administration of the GLP-2 therapy, OPK and Entera undertook a proof-of-concept single-dose pharmacokinetic research in rodents. The study tested two administration processes — intravenous (IV) injections (2 mg/kg; n = 6) and oral tablets (1.8 mg; n = 15). Blood samples were obtained 24 hours after the medicine was administered for pharmacokinetic analysis using a validated LC-MS/MS method to determine drug concentrations.
The goals of the trial were achieved by the oral GLP-2 pills showing a notable systemic exposure. Furthermore, plasma levels were almost 10 times greater for oral tablets of the GLP-2 therapy versus subcutaneous injection of teduglutide.
Rat plasma half-life was found to be almost six times longer by pharmacokinetic analysis of data collected after intravenous injections of the GLP-2 therapy than it was for teduglutide in the same animal model. This information aligns with previously published PK data about the long-acting profile of OPK's GLP-2 peptide, which was first created as a weekly subcutaneous injection.
The companies are looking forward to updating these data later in 2024.
Comparison With Peers
Takeda Pharmaceuticals currently distributes the GLP-2 analog, GATTEX, in the United States and REVESTIVE in Europe. Takeda announced the FDA’s approval for extending the indication of GATTEX for injection to pediatric patients aged one year or older with SBS who need additional nutrition or fluids from IV feeding. TAK also aims at improving the lives of patients with gastrointestinal disorders through the delivery of innovative medicines and dedicated patient disease management support, which can lead to a competitive challenge for OPK’s business.
Ironwood Pharma IRWD is focused on the development and commercialization of treatments primarily addressing gastrointestinal diseases.
With the acquisition of VectivBio, a Switzerland-based biotech company, in June 2023, Ironwood gained the rights to develop and market apraglutide. This candidate is being evaluated in the phase III STARS study for treating short-bowel syndrome patients with intestinal failure. In February, IRWD announced positive top-line data from the pivotal phase III STARS study, which met the primary endpoint of relative change from baseline in actual weekly PS volume, comparing apraglutide versus placebo at week 24 of treatment. A successful development of Ironwood's candidate may increase competition for Opko Health's under-development GLP-2 therapy.
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