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news.Vancouver-based iCo Therapeutics has completed drug product manufacturing activities as part of its Phase 2 clinical program investigating multiple doses and injections of iCo-007 in patients with diabetic macular edema (DME).
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iCo is evaluating potential clinical activities in several regulatory jurisdictions, including Canada, where it has received a No Objection Letter from Health Canada’s Therapeutic Products Directorate related to its submitted Phase 2 DME clinical trial plan.
Designed and discovered by ISIS Pharmaceuticals, iCo-007 is a second-generation antisense drug targeting c-Raf kinase for the treatment of DME and diabetic retinopathy.
iCo-007 completed an open label, dose escalating Phase 1 trial with safety as the primary endpoint, and visual acuity and measures of retinal thickness serving as secondary endpoints.
Importantly, iCo saw no drug-related serious adverse events, no signs of ocular inflammation, no intraocular pressure issues and no systemic exposure. Encouraging trends in measured secondary endpoints warrant further investigation.
Four US clinical sites participated in the trial.