“These results, in combination with our approval from the FDA to utilize a 505(b)(2) pathway, provide a clear pathway to approval that can be leveraged for many pharmaceutical products using the Optimμm® technology platform,” says Maria Flynn, President and CEO, Orbis Biosciences.
Orbis Biosciences Completes Successful Phase I Clinical Trial
LENEXA, KS – May 19, 2017 – Orbis Biosciences, Inc., is proud to announce the completion of its first-in-human clinical trial with ORB-101, its taste-masked prednisone product. This study is a continuation of the successful palatability study in which Orbis demonstrated that ORB-101 significantly outperformed the currently marketed drug in the key categories of taste and compliance.
This pilot bioavailability study marks a key milestone in showcasing the capabilities of Orbis’ Optimμm® technology. Among these proven capabilities are the ability to mask bitter and foul-tasting drugs without compromising total-body exposure of the drug in human patients and the delivery of extended-release formulations in patient-friendly formats. Orbis delivers these capabilities via its proprietary technology, which offers R&D to scaled manufacturing reproducibility for speed to market.
Orbis’ Primary Investigator, Dr. Gregory Kearns of Arkansas Children’s Hospital, led both the bioavailability trial and the previous palatability study testing Orbis’ taste-masked prednisone product. When describing the results of the palatability study, Dr. Kearns noted, “This study proved, without a shadow of a doubt, that Orbis’ technology is completely effective at taste masking.”
The Optimμm® technology is available for licensing.
About Orbis Biosciences – Orbis is a pharmaceutical manufacturing technology company focused on licensing its technology to pharmaceutical companies to optimize their product portfolios. Orbis develops customized formulations and intellectual property for pharmaceutical product manufacture, leveraging Orbis’ novel technology platforms: Optimµm® precision encapsulation for oral delivery, StratµmTM precision encapsulation for injectable delivery, and the Unisun® platform for enabling sustained-release otic therapies. Providing industry innovation, the company offers cost-effective reformulation pathways to improve pharmaceutical products for improved health outcomes.
Media Contact: Brad Spitz (913-544-1199)