Annexin Pharmaceuticals develops the drug candidate ANXV with the goal of offering a new type of treatment for the eye disease retinal vein occlusion, RVO. ANXV is 99,5 percent identical to the body's own protein Annexin A5, which protects cells in blood vessels, is anti-inflammatory and reduces the tendency of red blood cells to clump together, which are some of the main causes of RVO. ANXV is given intravenously and in this way the company wants to offer a significantly more patient-friendly and effective treatment compared to today's main alternative, which requires repeated anti-VEGF injections into the eye and also has limited effect.
Annexin also has two cancer tracks where the candidate is being explored in immuno-oncology and through conjugation with cytotoxic agents, which opens up significant opportunities in this field as well.
Phase II study completed recruiting
On Thursday last week, Annexin announced that it had chosen to close recruitment for the Proof-of-Concept Phase II study in RVO. The study includes patients with newly diagnosed and untreated RVO. The company chose to close recruitment because 15 patients have now been treated with ANXV at various dose levels from 2 mg, 4 mg and 6 mg, and where no treatment-related adverse events have been reported to date.
– We are very pleased to see the continued favorable safety and tolerability profile of ANXV. This is the first study with ANXV in a patient population and it is extremely important that a new investigational drug demonstrates a safety profile that enables further development, says Dr. Anna Frostegård, CSO and CMO at Annexin Pharmaceuticals.
Continued positive impact signals
In addition, where information is available for at least three months after treatment, signs of efficacy have been shown in 8 out of 10 of these patients. These signs of efficacy include more stable visual acuity and reduced swelling in the eye.
Among the patients who have been followed for at least two months, 10 out of 12 have been assessed as not needing any – or only one – anti-VEGF treatment. This can be compared to the fact that patients affected by RVO typically need 4–6 such treatments in the first year.
The biological effect signals in the eye that the patients showed are well consistent with ANXV's presumed mechanisms of action, which provides the company with support that ANXV works in humans in exactly the way it was hoped. Annexin is expected to report top line data from the study in the summer of 2024. Before that, the company plans to conduct a rights issue of approximately SEK 14 million between May 28–45.