Qrono Inc. today announced that the Food and Drug Administration (FDA) awarded Qrono a $612K contract to design and construct physiologically-based pharmacokinetic models relating the critical quality attributes of long acting injectable microspheres to in vivo performance.
Long-acting injections (LAIs) that rely on complex microsphere formulations, such as Sandostatin LAR and Risperdal Consta, have been improving the lives of patients for nearly two decades. Generic versions of these and other complex formulations would reduce billions of dollars in strain on our nation's healthcare systems and allow a broader range of patients to benefit from medications that improve adherence, improve patient outcomes, and improve overall quality of care. Yet patients lack generic formulations of these products, due in large part to the high clinical and research burden to develop these generics and demonstrate bioequivalence.
The primary objective of this program is to compare a computationally driven approach to a more experimentally intensive approach for the development of complex long acting injectable microspheres. Qrono's initial studies will focus on Risperdal Consta and Sandostatin LAR as two model drug products. Qrono aims at developing microsphere formulations that have the same composition and can provide the same therapeutic performance as these two model products through the proposed computationally driven approach. Completion of these studies will yield valuable data about approaches to designing long acting injectable microspheres that may also be applicable to other complex products. Qrono's long-term objective is to establish computational drug delivery simulations as the state-of-the-art best practice for the development of reformulated LAI products.
"It is beneficial for pharmaceutical and regulatory scientists to have a method that can assess the impact of formulation composition of LAI products on their drug release and clinical pharmacokinetic profiles in a more timely and cost-effective way than the standard experimental approach," said Qrono CEO Larry Zana. "The long term goal of this project is to establish product development methods for long acting, complex drug products that will facilitate the production and regulatory approval of generic LAIs for patients in need of efficacious and cost-effective solutions to adherence and drug delivery challenges."
LAI medications have been approved since the early 1990s, but to date there has not been a single generic LAI approved in the US due to the large burden on industry and the complex nature of the LAI formulations. The developed technology, which will streamline preclinical development, scale up, and clinical testing, will reduce financial risk, thus facilitate generic industries in developing generic forms of LAI products. Successful completion of this project will also help the Agency understand how drug product characteristics relate to in vivo performance and aid in understanding how simulation can be utilized to determine bioequivalence standards for LAI products.
This contract is funded by the FDA. The views, opinions and/or findings contained herein are those of the author and should not be construed as an official FDA position, policy or decision unless so designated by other documentation.
About Qrono:
Qrono reformulates FDA approved drug products and creates new, long-acting injectable (LAI) medications with improved clinical and economic benefits. Our product pipeline focuses on therapeutic areas where LAIs offer high therapeutic and economic value, such as addressing high non-adherence or solving specific drug delivery challenges. Using our computational drug delivery technology, we can design LAIs significantly faster than legacy practice and with reduced regulatory and technical risk.