OcuTerra Announces Topline Data from Phase 2 DR:EAM Trial Evaluating Nesvategrast (OTT166 5%) for Patients with Diabetic Retinopathy

2024-03-14

临床2期临床结果

Nesvategrast (OTT166 5%) was demonstrated to be safe and well tolerated but did not meet primary efficacy endpoint Company will further analyze DR:EAM secondary endpoints and other measures OcuTerra is evaluating strategic alternatives BOSTON--(BUSINESS WIRE)-- OcuTerra Therapeutics, Inc. (“OcuTerra”), a clinical stage ophthalmology company developing innovative drugs to treat ophthalmic diseases, today announced topline results from its Phase 2 DR:EAM (Diabetic Retinopathy: Early Active Management) clinical trial of nesvategrast (OTT166), a novel, selective RGD integrin inhibitor developed as an eye drop. The clinical trial did not meet its primary or key secondary efficacy endpoints. Nesvategrast (OTT166 5%) was shown to be safe and well tolerated, meeting its primary safety endpoint. OcuTerra plans to evaluate its strategic alternatives and will share additional details at a later date. “We are disappointed that the topline data on nesvategrast from our Phase 2 DR:EAM clinical trial did not demonstrate a statistically significant impact on severity or progression of diabetic retinopathy,” said Kerrie Brady, CEO and President of OcuTerra. “We plan to review the full dataset from the DR:EAM study to evaluate the future of the nesvategrast program. I want to wholeheartedly thank the patients and investigators who participated in the DR:EAM trial as well as the OcuTerra team for making this study possible.” Topline data did show nesvategrast was safe and well tolerated. However, the data failed to demonstrate a statistically significant improvement on the diabetic retinopathy severity scale (DRSS) for patients treated with nesvategrast compared to the placebo group, the primary efficacy endpoint. Data also did not show nesvategrast to have significant impact on the progression of disease as measured by DRSS, a key secondary endpoint. However, analysis of the development of vision threatening events (VTEs), another key secondary endpoint, stratified by level of disease severity at baseline, demonstrated a statistically significant improvement in patients with DRSS level 47 and 53 (moderately severe, and severe non-proliferative diabetic retinopathy respectively) at baseline in preventing the onset of VTEs by week 24 (p=0.045). “OcuTerra’s work is based on scientific rigor and commitment to identifying the best possible opportunity to improve the lives of patients living with serious ophthalmic diseases,” said David Tanzer, M.D., Chief Medical Officer of OcuTerra Therapeutics. “While our Phase 2 topline data did not show the efficacy we had hoped, we had advanced the program with substantial preclinical and clinical data and will use learnings to help inform the ophthalmic community and their future work.” About the DR:EAM Clinical Trial DR:EAM is a multicenter, randomized, double-masked clinical trial designed to assess the safety and efficacy of a high and low dose of daily topical administration of nesvategrast (OTT166) versus placebo for 24 weeks in 225 adult patients with moderately severe to severe NPDR or mild PDR with minimal vision loss. The primary efficacy endpoint of the clinical trial is the percentage of patients that have a ≥2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS). Additional endpoints of the clinical trial include measuring the prevention of progression to vision-threatening events, amount of delayed time to intravitreal injection and/or laser treatment, and exploratory imaging endpoints. More information about this trial is available at ClinicalTrials.gov. About Diabetic Retinopathy Diabetic retinopathy is the most common diabetic eye disease and the leading cause of vision loss and blindness in American working age adults, which affects nearly 10 million people in the US1. The current standard of care for diabetic retinopathy is active surveillance or “watch-and-wait”2 until a sight threatening complication arises. When vision deteriorates further due to complications, the patient must undergo injections of medication directly into the back of their eye (intravitreal injection) or undergo destructive laser procedures to help stop the growth of new blood vessels and decrease fluid buildup. About Nesvategrast Nesvategrast (OTT166) is an investigational, novel, patented, potent and selective small molecule RGD integrin inhibitor designed with purpose engineering to have an optimum balance of physiochemical properties to allow it to distribute to the retina in high concentrations after topical (eye drop) administration to the eye. In preclinical studies, nesvategrast selectively inhibited key RGD integrin subtypes, including αvβ3, to regulate cellular responses to VEGF and other growth factors known to contribute to development and progression of diabetic retinopathy and other ocular diseases. In early clinical trials in patients with diabetic retinal disease, nesvategrast eye drops have demonstrated preliminary evidence of tolerability and biological activity. About OcuTerra Therapeutics OcuTerra Therapeutics, Inc. is developing innovative drugs for ophthalmic diseases for which the current standard of care does not prevent or control the early progression of disease. Our initial therapeutic candidate, nesvategrast (OTT166), administered as an eye drop containing a novel, potent and selective integrin-inhibitor, is in clinical development as an early, non-invasive intervention for diabetic retinopathy, a chronic, progressive disease that is one of the leading causes of vision loss globally. Our goal is to bring transformative treatments to patients and their clinicians who are currently consigned to watch and wait as disease progresses, ultimately requiring medically intensive and invasive therapy. ___________________________ 1 Lundeen EA et. Al. Prevalence of Diabetic Retinopathy in the US in 2021. JAMA Ophthalmology doi:10.1001/jamaophthalmol.2023.2289 Published online June 15, 2023. 2 American Academy of Ophthalmology: Preferred Practice Pattern for Diabetic Retinopathy, 2019