Annexin Pharmaceuticals has announced that an independent evaluation of potential signals of effect has been carried out in the company’s Phase 2-study in retinal vein occlusion with the investigational new drug ANXV.
Positive findings justify an extended follow-up period, states the company.
“With these early signals in the RVO study, a favorable safety profile and the imaging data that we reported last spring, we have several interesting clinical findings. In the simplified study design we are removing the placebo group and altogether we believe the changes will accelerate patient enrolment,” says Anders Haegerstrand, CEO.
A group of leading independent US ophthalmologists has conducted an evaluation of the available information from patients treated so far in the placebo-controlled study. The evaluation confirmed an unexpectedly long duration of effect with a single dose of standard of care anti-VEGF treatment in two of five treated patients. These two patients also had some positive effects on visual acuity and the retina already during the four weeks before standard of care treatment was used. The expert group recommended unmasking the treatment to clarify whether the treated patients received placebo or ANXV. The unmasking showed that the two patients with potential signals of effect had received ANXV. No clear signals of effect were observed in the other patients in the study where two had received ANXV and one had received placebo. The experts also recommended that the study should continue with a longer follow-up time and without a placebo group, since ANXV treatment has not raised safety concerns.
It is not possible to draw any firm conclusions from two patients, but it is unusual for such patients to respond to just a single anti-VEGF injection in the first six months after diagnosis.”
“The observations are interesting and indicate that ANXV may have a positive effect on the course of the disease in RVO, which is in line with our hypothesis. It is not possible to draw any firm conclusions from two patients, but it is unusual for such patients to respond to just a single anti-VEGF injection in the first six months after diagnosis. We intend to recruit and treat two more patients at the current dose and up to ten patients at a higher dose to gather more safety and tolerability data and to possibly confirm signals of effect,” says Anna Frostegård, Chief Scientific and Medical Officer at Annexin.
Photo of Anders Haegerstrand: Annexin