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Interface Biologics Announces Spinout, Ripple Therapeutics

,p.TORONTO, Canada, January 14, 2020 – Following the sale of its surface modification business to Evonik (EVR:ETK), Interface Biologics Inc. (“IBI”), is pleased to announce the launch of Ripple Therapeutics Corporation (“Ripple”), a privately held, clinical stage developer of novel drugs.

The Ripple Epidel ® technology is founded on a discovery that drugs can be engineered into controlled release Pharmaceuticals and Medical Device Coatings 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 and micro/nanoparticles) or as coatings on medical devices. 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’s lead product, IBE-814 IVT, is a fully degradable intravitreal dexamethasone prodrug implant that targets diabetic macular edema and retinal vein occlusion.  IBE-814 is designed to deliver a low, consistent, efficacious dose for six to nine months which is significantly longer than the leading commercial product.  With ~1/10th the drug loading, there is also the potential of reducing the steroid-related adverse events that affect the current commercial products.  The FDA has confirmed an abbreviated regulatory path via 505(b)(2) and the company is planning to initiate its Phase II clinical trial in Australia in the second half of 2020.

“Following the successful sale of our surface modification business to Evonik, we felt that the best way to capitalize on our Epidel technology was to create a new company – Ripple Therapeutics – in order to facilitate incremental investment,” stated Tom Reeves, President & CEO of Interface Biologics and Ripple Therapeutics. “IBI will continue to focus on its licensing agreement with Fresenius Medical Care and to develop its drug coated balloon program using the Kinesyx platform. The majority of former IBI management and employees will transition to Ripple Therapeutics.  Ripple’s initial focus is in ophthalmology, but this technology platform has wide ranging capabilities for sustained local drug delivery across a variety of drug classes and therapeutic areas.  We are actively pursuing a $25M Series A financing which will allow us to take our lead product, IBE-814 IVT, through a Phase II clinical trial as well as to continue to develop the technology platform and other product applications.”

About Interface Biologics:

Interface Biologics (IBI) is an early commercial stage privately held company that develops innovative materials for Medtech applications. IBI surface modification additives are used in FDA- approved medical devices and are clinically proven to reduce infection and thrombus-related complications.     www.interfacebiologics.com

About Ripple Therapeutics:

Ripple Therapeutics Corporation is an early clinical stage privately held company that develops novel drugs. Ripple’s EpidelÒ technology is founded on a discovery that drugs can be engineered into controlled release Pharmaceuticals and Medical Device Coatings 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 or as coatings on medical devices. www.rippletherapeutics.com

Media Contact:

Julie Fotheringham, Partner, Hageman Communications

M: 416-951-7988 E: Julie.fotheringham@hageman.ca

16 Apr, 2024
TORONTO, ON, CANADA / APRIL 4, 2024 - Ripple Therapeutics Corporation, a clinical stage company focused on improving ophthalmic therapeutics with controllable sustained delivery implants, was pleased to present at Eyecelerator @ ASCRS 2024 in Boston.
28 Mar, 2024
TORONTO, ON, CANADA / MARCH 28, 2024 - Ripple Therapeutics Corporation, a clinical stage, ophthalmology-focused developer of novel therapeutics, is presenting findings from the RIPPLE-1 clinical trial of the IBE-814 IVT Implant at a number of key Ophthalmology conferences. Results from RIPPLE-1 showed reduced CST and improved or stable BCVA at Month 6 in all cohorts (high dose and low dose, DME and RVO), a reduction in treatment burden compared to pre-study and safety comparable to other intravitreal steroids. Long-term follow-up is now complete, and analysis of the final data set is in progress. The IBE-814 IVT Implant is comprised solely of a prodrug, IBE-814, and enables sustained dexamethasone delivery to the retina over a period of at least 6 months. The implant is administered by intravitreal injection using a 30G needle. RIPPLE-1 was a first-in-human phase II, multi-center, single-masked dose-ranging study designed to evaluate the safety, efficacy, and durability of two dosage regimens of the IBE-814 IVT Implant. The study enrolled 60participants with diabetic macular edema (DME) and retinal vein occlusion (RVO). Participants were randomized to receive either the low dose (70 µg) dexamethasone, one implant) or high dose implant (140 µg dexamethasone, two implants) and were followed for up to 18 months post-baseline treatment. Presented: American Academy of Ophthalmology (AAO) Date: November 4, 2023 Presenter: Sumit Sharma, MD, FASRS Title: Intravitreal Sustained-Release Dexamethasone Implant for DME and RVO: 6-Month Results from the First In-Human Phase 2 RIPPLE-1 Trial View Presentation Hawaiian Eye and Retina Date: January 18, 2024 Presenter: Sumit Sharma, MD, FASRS Title: Intravitreal Sustained-Release Dexamethasone Implant for DME and RVO: 9-Month Results from the First In-Human Phase 2 RIPPLE-1 Trial View Presentation Angiogenesis, Exudation, and Degeneration Date: February 3, 2024 Presenter: Baruch Kuppermann, MD, PhD Title: Intravitreal Sustained-Release Dexamethasone Implant for DME and RVO: Interim Results from the First In-Human Phase 2 RIPPLE-1 Trial View Presentation Accepted: The Association for Research in Vision and Ophthalmology (ARVO ) Date: May 9, 2024 Session: 530 Diabetic macular edema, 11:45 am Presenter: Hemal Mehta, MBBS MD(Cantab.) FRCOphth FRANZCO Title: Efficacy and safety of a low dose dexamethasone implant for diabetic macular edema and retinal vein occlusion: Results of the first-in-human phase 2 RIPPLE-1 trial Date: May 7, 2024 Session: 320 Retinitis pigmentosa and macular diseases, 8:30 am Presenter: Wendy Naimark, PhD, on behalf of Kelli Wootton, MASc Title: IBE-814 IVT Implants demonstrate a treatment burden reduction in subjects with DME and RVO due to extended-release of dexamethasone: An analysis of the first-in-human phase 2 RIPPLE-1 trial Retina World Congress Date: May 12, 2024, Session: Late Breakers, 11:15 am Presenter: Baruch Kuppermann, MD, PhD Title: Ripple Therapeutics Steroid Drug Delivery Clinical Trial for DME and RVO About Ripple Therapeutics Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple’s Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with surface erosion release kinetics without the use of polymers or excipients. Ripple’s novel therapeutics provide for better outcomes for patients, easier management of care for physicians and lower costs for payors. Ripple has a full product pipeline in development. www.rippletherapeutics.com  Media Contact Julie Fotheringham, V.P. Marketing, People & Culture M: 416-951-7988 E: jfotheringham@rippletherapeutics.com
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