Epidel™ is founded on a discovery that with a small amount of chemical engineering drugs can be designed to deliver themselves without the need for polymers or excipients. Epidel™ prodrug materials are readily manufactured into implantable forms like cylinders and microspheres. Drug dissolves from the surface of the Epidel implant via surface erosion in a highly predictable manner: dose is dictated by implant surface area; dose duration by implant diameter. The result is an ability to finely tune pharmacokinetics to meet the needs of a target indication with precision control of drug dosing without the bulk added by a polymer.

In the true spirit of invention, Epidel was borne out of constraint. In the mid-nighties the Controlled Release Field was focused on conjugating drugs into polymer backbones as a way of controlling drug release. While the science was conceptually appealing the lack of reproducible manufacturing and the complexity of a polydisperse polymeric breakdown profile limited the translation into approval products. There are still no approved products in this class.

In our Toronto laboratories, constraint inspired a “What if” line of thinking: What if we could create a drug conjugate that is so small that when it dissolves from a surface it cleaves into the active drug and a small biocompatible linker component in a highly predictable, uncomplicated, and reproducible manner?

In 2016, the Team was working on a promising Epidel™ prodrug for medical device coating applications. Now known as IBE-814 within the Epidel™ family, the dexamethasone triethylene dimer, coated on typical medical device surface such as stainless steel and polyurethane, exhibited highly reproducible zero-order release kinetics. A highly unexpected result given the only thing controlling the release of the drug from the surface was the small molecule prodrug itself: a demonstration of a small amount of chemical engineering can lead to drugs that deliver themselves.

The next remarkable surprise was that IBE-814 could be formed into fibers all on its own. Completely unpredicted given that we don’t expect small molecules to have the mechanical integrity to form 3-dimensional objects.

Realizing the potential of this discovery, the Ripple Team shifted their focus to Pharma applications. Ophthalmology was a natural place to start given the large unmet need that centers around challenges with patient compliance and durability of benefit with current therapies. The added benefit being the small size of the Epidel implant relative to other implants due to the lack of an additive polymer casing.

The Ripple Team has gone on to demonstrate how processable these Epidel materials are using standard polymer manufacturing techniques. The preclinical PK, PD, and degradation data strongly correlate to support the slow sustained surface erosion based mechanism of drug release. This data is now translating into the clinic demonstrating the potential to design Epidel prodrugs with meaningful therapeutic potential.

Pharma focus. Clinical stage. Pipeline. Platform.