RBP4 Pty Ltd, a subsidiary of Lin BioScience, has applied for a Phase I clinical trial on the interaction between food and drugs in healthy adults in Australia, and Bonvadis, a topical wound cream developed by Oneness Biotech, has filed an application for registration with the Food and Drug Administration (FDA) of Thailand.
A new drug, LBS-008, a retinol-binding protein 4 antagonist (RBP4 Antagonist), is subject to review of a Phase 1b clinical trial on the interaction between food effects and drugs in healthy adults.
The clinical trial is a single-centre, open-ended study of 48 healthy adults aged 18-55 years in Australia and will assess the effect of food on LBS-008 and whether LBS-008 interacts with a number of drugs based on pharmacokinetic (PK) results.
In addition to food effects and drug-drug interactions, LBS-008 is also being tested in global Phase III trials for the treatment of advanced dry macular degeneration and Steger's disease. According to statistics, about 20 million people in the U.S. suffer from macular degeneration, and about 200 million people worldwide suffer from macular degeneration, 90% of which are dry macular degeneration for which there is no effective oral drug.
Oneness Biotech adopts a parallel strategy for wound care products, including Bonvadis, which has already obtained marketing approval in the U.S., India, New Zealand, and South Africa, and has filed an application with the FDA in Thailand for registration of Bonvadis Wound Topical Cream. In order to expand the wound use, Oneness has also filed a 510(k) application with the U.S. FDA to add a number of chronic wound indications, and will continue to file market access in countries where the company plans to market Bonvadis.