Latest news with #NPDR
Business Wire
29-07-2025
- Business
- Business Wire
Exonate plans ‘CLEAR-DE' Phase IIb clinical trial of lead candidate EXN407 for diabetic eye disease
CAMBRIDGE, England--(BUSINESS WIRE)--Exonate Ltd., a biotechnology company developing novel, non-invasive, small-molecule therapeutics for patients with retinal vascular diseases, today announced plans to initiate a Phase IIb clinical trial for its lead candidate EXN407. The CLEAR-DE (Clinical Evaluation of a New Eye Drop for Alleviating Retinopathy in Diabetic Eye Disease) trial will further evaluate the clinical efficacy, optimal dosing and safety profile of EXN407 in patients with non-proliferative diabetic retinopathy (NPDR). The progression to a Phase IIb clinical study follows encouraging results from Exonate's Phase Ib/IIa study in March 2024. In the study, lead candidate EXN407 met its primary safety and tolerability endpoints, with no drug-related serious adverse events, and high patient compliance. Importantly, exploratory efficacy signals showed a reduction in vascular leakage, a key pathological driver in diabetic retinopathy. The Phase IIb trial to investigate the efficacy of EXN407 in NPDR patients is planned to begin in early 2026, with 140 patients currently enrolled across multiple sites in Australia, the Middle East and China. Diabetic retinopathy (DR) is a leading cause of vision loss globally. An estimated one-third of the nearly 500 million people living with diabetes are affected by NPDR, the early stage of diabetic eye disease, which can lead to more severe, vision-threatening complications. Current therapeutic approaches involve monthly intraocular injections, initiated only after symptoms appear. This limits opportunities for early therapeutic benefit, and due to the invasive nature and frequency, is often deferred until irreversible damage has occurred. EXN407 is a first-in-class, twice-daily topical formulation of a selective SRPK1 inhibitor – a minimally-invasive approach with potential to become the first effective eye-drop therapy for NPDR and diabetic macular oedema (DME). Designed to modulate expression of vascular endothelial growth factor (VEGF) via alternative mRNA splicing, EXN407 selectively inhibits the pro-angiogenic isoforms that drive disease progression, causing abnormal and leaky blood vessel formation in the retina. ' The Phase Ib/IIa data demonstrated the clear potential of EXN407 as a non-invasive treatment for diabetic eye disease, ' said Dr. Catherine Beech, Chief Executive Officer of Exonate. ' This therapy could transform the treatment landscape for early-stage disease by providing clinical benefit while avoiding the burden of injections, representing a significant advancement for patients and physicians alike. We're excited to progress to the CLEAR-DE Phase IIb trial and are actively seeking strategic partners to support its execution.' For more information about Exonate's pipeline and clinical development plans, please visit:
Yahoo
11-04-2025
- Health
- Yahoo
Vantage Biosciences Doses First Patient in Phase 2 Clinical Study of Oral VX-01 for Non-Proliferative Diabetic Retinopathy
LONDON, April 11, 2025 (GLOBE NEWSWIRE) -- Vantage Biosciences, a clinical stage biotechnology company advancing innovative therapies for diabetic eye diseases, today announced that the first patient has been successfully dosed in its Phase 2 clinical study evaluating VX-01, an oral therapy for the treatment of non-proliferative diabetic retinopathy (NPDR). Diabetic retinopathy affects more than 100 million people worldwide and is one of the leading causes of blindness among working-age adults. Without timely intervention, NPDR can progress to more severe stages of diabetic eye disease, increasing the risk of vision loss. This milestone marks a significant step forward in the clinical development of VX-01, potentially the first oral treatment for this condition, designed to target the inflammatory mechanisms underlying NPDR progression. 'We are pleased to initiate patient dosing in this important Phase 2 study, which evaluates VX-01 as a potential early intervention for diabetic retinopathy,' said Alek Safarian, Co-Founder and Chairman of Vantage Biosciences. 'By targeting the disease at an earlier stage, VX-01 has the potential to slow or prevent progression to more severe forms of diabetic retinopathy, reducing the likelihood that patients will require invasive treatments in the future.' The Phase II study is expected to read out in 2027 and is being run at 27 sites across the US, Australia, and a number of Southeast Asian countries. About the VX01-DR-201 Study This is a Phase 2, multi-center, double-masked, randomized, placebo-controlled study designed to evaluate the efficacy of oral dose of VX-01 in patients with moderate to severe NPDR without center-involved diabetic macular edema (CI-DME). Eligible participants will be randomized 1:1 into one of two study cohorts. All participants will take VX-01 or placebo BID for 52 consecutive weeks, followed by a 12-week post-treatment observation period. About VX-01 VX-01 is an orally administered small molecule therapy designed to target neurovascular inflammation associated with diabetic eye disease. By addressing the underlying biological processes that contribute to microvascular complications in the retina, VX-01 aims to slow or prevent disease progression in NPDR patients before irreversible vision loss occurs. About Vantage Biosciences Vantage Biosciences is a clinical stage biotechnology company dedicated to developing innovative therapies for diabetic eye diseases. Founded by ALSA Ventures, the company is committed to scientific excellence and patient-centred approach in advancing treatments that address significant unmet medical needs in diabetic eye disease. Vantage Biosciences is backed by ALSA Ventures, a leading biotech investment firm focused on the creation and development of breakthrough therapeutic companies. For more information, visit ALSA Ventures. CONTACT: Media contact: DMG Biopharma Agency Susan Fitzpatrick-Napier Team@ in to access your portfolio
