We collaborate with Pharma Partners interested in evaluating our prodrug technology with their unique APIs and Medical Device Partners interested in coating our prodrug technology on their devices to improve functionality and/or longevity.
The Ripple Therapeutics’ Epidel® technology is founded on a discovery that drugs can be engineered into controlled release materials without the use of polymers or excipients. The proprietary prodrugs are new chemical entities (NCEs) that have unique properties that allow them to be processed into standalone drug delivery implants (e.g. intravitreal implants, micro/nanoparticles, etc.) or as coatings on medical devices. Ripple Therapeutics’ implants and coatings are made up entirely from the prodrug without a polymeric carrier to control the implant or drug release properties. The implants and coatings undergo surface erosion to give zero order drug release profiles and are highly engineerable (e.g. different forms, shapes, and sizes) to tailor drug dose and duration for the specific indication of interest. The flexibility in molecular design results in drug doses that are within the therapeutic window, delivering the right amount of drug for the right amount of time. This has the potential to improve patient safety and clinical outcomes.
Ripple Therapeutics is developing a library of proprietary prodrugs with unique polymer-like properties from different active pharmaceutical ingredients and local, sustained drug delivery products from these. Ripple Therapeutics is developing products on their own and in combination with strategic partners.
IBE-814 Dexamethasone-Releasing Intravitreal Implant (IBE 814-IVT)
IBE-81 IVT is aimed at being best-in-class therapy for the treatment of posterior inflammatory eye diseases, including diabetic macular edema (DME), retinal vein occlusion (RVO) and non-infectious uveitis (NIU). The IBE-814 IVT implant is minimally invasive, delivered through a 30-gauge needle (vs. currently marketed intravitreal sustained-release steroid therapies which range from 22-25 gauge needle delivery). IBE-814 is designed to deliver a low, consistent, efficacious dose for approximately six to nine months. Our goal is to extend clinical benefit while decreasing common steroid-induced adverse events.
Ripple Therapeutics (formerly Interface Biologics) held a positive pre-IND meeting with the FDA in October 2018, securing agreement on a 505(b)(2) regulatory pathway, including an accelerated clinical plan. Ripple is currently focused on CMC development to support initiation of a Phase II clinical trial in 2020 to treat DME and RVO.
Our lead product (IBE-814 IVT) is a fully degradable intravitreal dexamethasone prodrug implant targeting DME, RVO and NIU indications. Our target product profile is zero-order drug release for 6-9 months with a 30G needle and 1/10th the loading of the leading commercial IVT product which suggests a potential to reduce steroid related cataract and IOP AEs. We have a strong preclinical data set and the FDA has confirmed an abbreviated regulatory path via 505(b)(2). We are currently planning a 50 patient, two dose Phase II clinical trial which will be initiated in Australia in Q3 2020
We are in the process of raising a $10-12M Series A round which will allow us to complete the Phase II clinical trial for our lead program as well as to continue to develop our technology platform. Our current investors will contribute ~$5M to the financing so we are looking for external investors for the balance of the round.
Our team is made up of Chemists, Engineers and Material Scientists. Our leaders are experienced in managing industries through various stages of growth.
We post all open positions on this website, and regularly review applications for employment from experienced individuals interested in working on challenging projects. We thank all who express an interest in joining the company. Due to the volume of applications, only those individuals chosen for an initial interview will be contacted.