Phase 3 trial recruiting children with EB to test wound-healing cream
Study to see if experimental treatment SD-101 promotes wound closure
Written by |
Recruitment is now underway in a new Phase 3 clinical trial testing SD-101, an experimental cream designed to promote wound healing in people with epidermolysis bullosa (EB).
The Phase 3 SD-007 study (NCT07482787) is open to children, ages four weeks through 12 years, who have EB simplex, recessive dystrophic EB, or junctional EB. For two months, participants will apply either SD-101 or a placebo cream across the whole body every day.
The study’s main goal is to test if the therapeutic cream is better than the placebo at promoting wound closure. Participants who complete the placebo-controlled part of the study will have the option to continue into an extension trial where all will receive long-term SD-101 treatment.
The trial is sponsored by Paradigm Therapeutics, which is developing SD-101 after a 2023 deal with the therapy’s prior developer. According to Paradigm, the Phase 3 study is expected to enroll about 80 participants at 17 clinical sites across 14 countries. Recruitment is currently active at four sites in the U.S., and the first participant was recently enrolled.
“Initiating this Phase 3 study is an important milestone in the development of SD-101,” Robert Ryan, PhD, president and CEO of Paradigm, said in a company press release.
New study could support future application for approval
EB encompasses several diseases marked by abnormally fragile skin that is prone to wounds that do not heal well. SD-101 is a cream containing 6% allantoin, a compound believed to promote wound healing.
“People living with EB can experience skin blistering, chronic wounds, persistent pain and itching, infections, and scarring. Available treatment options have important limitations, and there remains a significant unmet need for therapies designed to address the widespread skin involvement associated with EB,” Ryan said. “We believe SD-101 has the potential to offer a different approach by targeting wounds and lesions across the skin surface in patients with EB simplex, recessive dystrophic EB, and junctional EB.”
SD-101 was previously tested in a Phase 3 study called ESSENCE (NCT02384460). That study failed to meet its main goal; SD-101 was no better than a placebo cream at promoting wound healing. One potential explanation for that failure is that the placebo cream was more effective than expected, because although it contained no allantoin, it did contain other compounds that may affect healing.
We believe SD-101 has the potential to offer a different approach by targeting wounds and lesions across the skin surface in patients with EB simplex, recessive dystrophic EB, and junctional EB.
Last year, Paradigm announced it was planning to pursue regulatory approval of SD-101 based on data from ESSENCE and earlier trials, but now the company has pivoted to running an additional Phase 3 study. Paradigm is hoping that the new study will help support an application for approval sometime in the future.
“Results from our completed Phase II and Phase III clinical studies support continued evaluation of daily, whole-body application, including its potential to promote target-wound closure and reduce the overall area of skin affected by lesions,” Ryan said. “We are committed to completing the development program and advancing SD-101 toward potential regulatory approval, with the goal of expanding treatment options for patients and families affected by this debilitating disease. We are also working with potential partners to support the therapy’s future global development and availability.”
Leave a comment
Fill in the required fields to post. Your email address will not be published.