Annexin Pharmaceuticals AB today announces a shortening of the ANXV treatment regimen from five to three days at the same dose level. A three-day treatment is expected to strengthen the commercial value of the ANXV program. To date, a total of six patients have been treated at the Retina Clinic London, including four patients with RVO (one of whom has received the three-day treatment) and two with DR. No safety-related findings have been observed to date. The company plans to provide more information on study results by the end of June.
The NEXUS study evaluates the drug candidate ANXV in the two retinal vascular diseases retinal vein occlusion (RVO) and diabetic retinopathy (DR) regarding safety, tolerability and signals of effect. The study is an important part of Annexin's clinical strategy for ANXV in ophthalmology.
As planned a review of safety and signals of effect data from three patients diagnosed with RVO, who received ANXV daily for five days, has been performed. No safety concerns were identified and based on signals of effect data the decision was made to continue at the same dose level and reduce the number of treatment days from five to three. The change aims to provide information regarding sustainment of the rapid effect signals following a three-day regimen and if this may be used in future Phase 2b and Phase 3 trials. In total six patients have received ANXV in the NEXUS study without safety concerns to date. One patient has already been treated for three days. Information on signals of effect will be provided before the end of June.
"A reduction of the number of treatment days from five to three would make ANXV more attractive in clinical practice, while reducing the burden on patients diagnosed with RVO. Combined with the positive signals of effect we have observed, this gives us strong confidence as we move toward the next development phase for the program. We are in a good position with the NEXUS trial and look forward to sharing emerging results before end of this quarter," says Anders Haegerstrand, CEO of Annexin Pharmaceuticals.
About the NEXUS study
Annexin's Phase 2a/proof of concept study NEXUS has an adaptive design and includes patients with diabetic retinopathy (DR), where there is a clear impact on retinal blood vessels and blood supply, as well as newly diagnosed RVO patients. It is an open-label study without a placebo group or comparison with another treatment. The study is being conducted at The Retina Clinic London, UK, with Professor Paulo-Eduardo Stanga as Principal Investigator, and from May 2026 also at STZ eyetrial, Department for Ophthalmology, University Hospital Tübingen, Germany, with Dr Immanuel P. Seitz as Principal Investigator.
The study is planned to initially include three patients with DR, as well as three patients with newly diagnosed RVO. Patients are treated with ANXV for five days and followed up with detailed tests for 30 days, after which decisions are made regarding further patient recruitment. If the results are deemed promising, the intention within DR is to increase the number of patients and within RVO to study whether the treatment time can be shortened to three days, which was initiated in May 2026.
All patients are followed less intensively for an additional 90 days to evaluate whether any effects persist. Both standard and high-advanced image analyses, functional and anatomical ophthalmological assessments, are performed monthly for four months following ANXV treatment. Evaluation is made of safety, tolerability and any signals of effect that may be related to ANXV. In addition to standardized tests of best corrected visual acuity (BCVA), the degree of diabetes-caused retinal damage, swelling of the retina and the need for anti-VEGF injections, objective functional tests and analyses of blood flow and vascular changes are performed. Initially, up to twelve patients in total are planned to be included in the study.
About diabetic retinopathy (DR)
DR is a serious eye disease and one of the leading causes of vision loss and blindness in people with diabetes. A significant proportion of patients suffer from vision loss during their working life. The disease occurs when high blood sugar levels damage the small blood vessels in the retina, leading to leakage, lack of oxygen and the formation of new, fragile blood vessels. Today's treatments include anti-VEGF injections, laser treatment, and surgery, but these are often costly, require repeated interventions, and do not always provide sufficient effect as they do not target the loss of blood flow in the retina. Therefore, there is a great need for new, more effective and long-term effective treatment options. Globally, it is estimated that over 100 million people are living with DR, and with an increasing prevalence of diabetes, the number of people affected is expected to rise sharply.
About Retinal Vein Occlusion (RVO)
RVO is a vascular disease of the eye in which blood flow in the retinal veins is acutely blocked. The disease often leads to severe visual impairment or blindness and the need for long-term treatment. Today's standard treatment for RVO consists of injections directly into the eye, usually once every 4 to 8 weeks, to treat swelling of the macula, the central area of the retina that we use to see details and distinguish between faces, but has no effect on the actual blockage of blood vessels that is the cause of RVO. Sources put the prevalence of RVO in the world at between 16 and 28 million people being affected. Most patients only have one eye affected. However, some patients may have a second occlusion in the same eye or an occlusion in the other eye.
For further information, please contact:
Anders Haegerstrand, CEO
Phone: +46 (0)70 575 50 37
Mail: anders.haegerstrand@annexinpharma.com
About Annexin Pharmaceuticals AB
Annexin Pharmaceuticals is a clinical stage biotechnology company active in the therapeutic areas ophthalmology and oncology. The company develops ANXV, a recombinant human Annexin A5 protein, as a first-in-class biologic with potentially disease-modifying mechanisms of action. The ANXV program is currently in Phase 2 in ophthalmology for retinal vein occlusion (RVO) and diabetic retinopathy (DR) and in pre-clinical stage in oncology.
The company is based in Stockholm and listed on Nasdaq First North Growth Market Sweden under the ticker ANNX. Redeye Nordic Growth AB is the company's Certified Adviser.
