Circadian Technologies Limited (ASX:CIR, OTCQX:CKDXY) through its wholly owned subsidiary Opthea Pty Ltd has unveiled that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate its Phase 1 clinical trial of OPT-302 in patients with wet age-related macular degeneration (wet AMD).
Circadian's CEO and Managing Director Dr Megan Baldwin said The FDA's acceptance of our IND for the Phase 1 clinical trial of OPT-302 is a major milestone for the Company. It is the result of a detailed review by the FDA of our non- clinical data package including preclinical safety/toxicology, efficacy testing and manufacturing processes for OPT-302, as well our Phase 1 study design. We look forward to bringing this important novel therapy to wet AMD patients for whom there remains a significant unmet medical need.
Opthea's first-in-human multi-centre clinical trial is a sequential dose escalation study of OPT-302 administered to patients with wet AMD on a monthly basis for three months by ocular injection either alone or in combination with ranibizumab (Lucentis). The primary endpoint of the study will be an assessment of the safety and tolerability of OPT- 302. Secondary endpoints include the pharmacokinetic profile of OPT-302 as well as preliminary measures of clinical efficacy as measured by visual acuity (eye charts) and sophisticated imaging techniques to determine retinal thickness and wet AMD lesion area using optical coherence tomography (OCT) and fluorescein angiography.
David Boyer MD, a Senior Partner at Retina-Vitreous Associates Medical Group and Clinical Professor of Ophthalmology at the University of Southern California Keck School of Medicine, and one of the clinical trial investigators, commented We are excited to be participating in this Phase 1 clinical study of OPT-302 as it is a promising novel therapy with potential to improve outcomes for wet AMD patients.
OPT-302 is a soluble receptor or Trap' molecule that blocks the activity of two proteins (VEGF-C and VEGF-D) that cause blood vessels to grow and leak. In preclinical models of wet AMD, OPT-302 demonstrates significant activity as a monotherapy and additive activity when used in combination with existing agents that block VEGF-A.
Dr Baldwin commented We are aggressively pursuing the development of this molecule following the compelling preclinical activity we have observed. Importantly, OPT-302 shuts down two proteins that are...