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Ripple Therapeutics Research on Polymer-Free Drug Delivery Published in Nature Communications

TORONTO, ON, CANADA / ACCESSWIRE / JUNE 1, 2021 - Ripple Therapeutics Corporation (“Ripple”), a clinical stage, ophthalmology-focused developer of novel pharmaceuticals, announced today that the article Polymer-Free Corticosteroid Dimer Implants for Controlled and Sustained Drug Delivery was recently published in Nature Communications.

The article describes Ripple’s Epidel™ technology platform which is founded on a discovery that drugs can be engineered into drug delivery implants 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. implantable cylinders, micro/nanoparticles, etc.) or as coatings for medical devices without a polymeric carrier. Ripple Therapeutics’ implants and coatings are made up entirely from the prodrug so when the drug is gone the implant is gone. The implants and coatings undergo surface erosion achieving tightly controlled and reproducible release kinetics. Drug release profiles 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 for a specified duration, delivering the right amount of drug for the right amount of time. This has the potential to improve patient safety and clinical outcomes.

“Surface erosion-based drug release enables the most controllable way to precisely design pharmacokinetics and pharmacodynamics for a target indication,” commented Dr. Wendy Naimark, Chief Technology Officer, Ripple Therapeutics. “We purposely design for simplicity to meet both safety and manufacturing goals. The less material the better from a physiological perspective and manufacturing simplicity is important for ensuring process control and ultimately a lower cost of goods.” 

Ripple recently announced that the first patients have been enrolled in RIPPLE-1, a Phase II clinical trial evaluating IBE-814 IVT, a proprietary intravitreal dexamethasone implant targeting DME (diabetic macular edema) and RVO (retinal vein occlusion) patients.  The trial seeks to provide a much-needed treatment option: a safer steroid implant with an extended clinical benefit.

Ripple is developing a full product pipeline including sustained release therapeutics for glaucoma, post cataract surgery and AMD.  Ripple’s glaucoma product (RTC-1119) is an intracameral prostaglandin implant for primary open-angle glaucoma.  The target product profile for RTC-1119 is to provide controlled, predictable drug release for 6-12 months and to allow retreatments as required.  The product is currently in preclinical development and the company is on target to submit a pre-IND in the second quarter of 2022.

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 zero-order release kinetics without the use of polymers or excipients.  Ripple has a full product pipeline in development. www.rippletherapeutics.com  

Media Contact

Julie Fotheringham, V.P. Marketing, People & Culture

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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