ANNEXIN PHARMACEUTICALS AB In
"We have every reason to be optimistic as we observe signals of effect and limited need for the standard anti-VEGF treatments in 6 out of 8 ANXV-treated patients followed for several months, especially as RVO patients typically need at least four intra-ocular injections of anti-VEGF within the first six months of diagnosis. It is encouraging that a patient with CRVO, and associated visual impairment and retinal swelling who would typically need multiple injections of anti-VEGF, experiences significant improvement for more than three months after being treated with ANXV alone. It is also important to emphasize that the study is not designed to show statistical significance regarding either safety or efficacy, but to provide information and guidance for an upcoming phase 2b study," says Dr. Anna Frostegård, Chief Scientific and Medical Officer at
Since the placebo group in the study was removed, the patient recruitment rate has increased and so far 11 patients have been enrolled, 10 have been fully treated and 8 have been evaluated for 3 months or longer. If the safety and signal of effect data do not motivate further patient enrolments in the study, the company expects to have evaluated the data from the study´s last patient by mid-2024.
"We are very pleased with these new observations that confirm our previously reported findings and our expectation that ANXV can have clinically meaningful and lasting effects on visual acuity and reduce the need for unwanted drug injections directly into the eye. We are approaching the timepoint where we can plan for further clinical studies based on additional promising clinical data. Activities to find a license partner are ongoing and I am convinced that today's update will generate increased interest" says
About the study
Annexin's phase 2a/proof-of-concept study includes patients who have recently suffered RVO, but have not been treated with the standard anti-VEGF therapy. After the protocol update, the study is an open-label study where patients receive the investigational new drug ANXV followed by anti-VEGF (as needed) and are followed up to four months with examinations to assess safety, tolerability and any signals of effect that may be related to ANXV. The company plans to include up to 16 patients at three different dose levels. The study is conducted at 7 different eye clinics in the US.
About retinal vein occlusion (RVO)
RVO isa vascular disease of the eye in which blood flow in the veins of the retina is blocked. The disease often leads to severe visual impairment or blindness and the need for long-term treatment. The treatments for RVO that are available today are injected directly into the eye, usually monthly, and have no effect on the blockage of blood vessels that causes RVO. According to a 2021 report by
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