Annexin’s phase II study fully recruited with positive signals
Annexin Pharmaceuticals has announced that the final patient has been treated in the phase II study with ANXV for the eye disease retinal vein occlusion. A total of 15 patients have been treated, and the results so far show a favorable safety profile and promising efficacy signals. The company is expected to present top-line data during the summer of 2024.
Annexin Pharmaceuticals is developing the drug candidate ANXV with the aim of offering a new type of treatment for the eye disease, retinal vein occlusion (RVO). ANXV is 99.5 per cent identical to the body’s own protein Annexin A5, which protects cells in blood vessels, has anti-inflammatory properties, and reduces the red blood cells’ tendency to clump together – all main causes of RVO. Since ANXV is administered intravenously, the company aims to offer a significantly more patient-friendly and effective treatment compared to today’s lead alternative, which requires repeated anti-VEGF injections in the eye and provides only limited effectiveness.
Annexin also has two cancer tracks where the candidate is being explored in immuno-oncology as well as through conjugation with chemotherapy drugs, opening up significant opportunities in this field as well.
Phase II study fully recruited
Last Thursday, Annexin announced that they had chosen to close the recruitment for the Proof-of-Concept phase II study in RVO, which includes patients with newly diagnosed and untreated RVO. The choice was made because 15 patients have now been treated with ANXV at different dose levels – 2 mg, 4 mg, and 6 mg – and no treatment-related adverse effects have been reported so far.
“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 exhibits a safety profile that allows for further development,” says Dr Anna Frostegård, CSO and CMO at Annexin Pharmaceuticals.
Continued positive efficacy signals
Additionally, where information is available for at least three months after treatment, efficacy signals have been shown in 8 out of 10 of these patients. These include improved visual acuity and reduced eye swelling.
Among the patients followed for at least two months, 10 out of 12 have not been deemed to need any – or only one – anti-VEGF treatment. This can be compared to patients affected by RVO usually needing 4-6 such treatments in the first year.
The biological efficacy signals in the eye shown by the patients are consistent with ANXV’s presumed mechanisms of action, providing the company with support that ANXV acts in humans just as they had hoped. Annexin is expected to report top-line data from the study during the summer of 2024. Before that, the company plans to conduct a rights issue of approximately SEK 45 million between May 14-28.
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