"It is very gratifying that we see continued progress in this important study. Five out of seven dedicated eye clinics have now treated patients with good experiences, which bodes well for continued recruitment. With more patients treated, we now hope to be able to confirm the promising effect signals, and with an increased dose, hopefully also strengthened", says
All six planned patients have now completed treatment in the phase 2 study's first patient group (cohort) where the patients were treated at the lowest dose level, 2 mg/day, for five days. No limiting side effects have been observed in the first cohort and after the recommendation by an independent Safety Review Committee, which evaluates the study based on safety, among other things, the first patient has now been treated in the second cohort of the study, where up to ten patients are planned to be treated with the higher dose, 4 mg/day, for five days. After two patients have been treated with the higher dose, a safety evaluation will be performed before the remaining patients can be enrolled. The company intends to continuously update the market on any efficacy signals, or any treatment-related side effects, as clinical data and other patient information have been verified and assessed by experts.
"During the autumn, we have visited several of our active eye clinics in the US and we are experiencing great enthusiasm after the promising signals of effect. We also see an increase in recruitment rates after we changed the study protocol and removed the placebo group. We remain committed to our plan to have all patients included in the study during the first quarter of next year and to be able to report 4-month follow-up data thereafter", says Dr. Anna Frostegård, Chief Scientific and Medical Officer at
In
About the Phase 2 study
Annexin's Phase 2 clinical trial includes patients who have recently received their RVO diagnosis, but who have not been treated with the standard anti-VEGF therapy. It is an open-label study in which patients receive ANXV followed by anti-VEGF (if needed) and followed for up to four months with examinations to evaluate safety, tolerability and any signals of efficacy related to ANXV. The company plans to include up to 16 patients, of which six patients have been treated at the lower dose level, 2 mg/day, and up to ten patients are intended to be treated at the higher dose level, 4 mg/day.
About retinal vein occlusion (RVO)
RVO is a 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 a 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
For further information, please contact:
About
The Company is based in
susanne.andersson@annexinpharma.com
Susanne Andersson CFO/IR @
https://news.cision.com/annexin-pharmaceuticals-ab/r/first-patient-treated-in-the-second-dose-group-in-annexin-s-rvo-study,c3859788
https://mb.cision.com/Main/15539/3859788/2381754.pdf
(c) 2023 Cision. All rights reserved., source