Annexin confirms promising results and strengthens financial position
Annexin Pharmaceuticals announces that the phase IIa study with its drug candidate ANXV for the eye disease retinal vein occlusion (RVO) has achieved all primary objectives. The results confirm previously reported topline data, demonstrating strong signals of effect and a favourable safety profile. The company has also announced a capital raise of approximately SEK 50 million, primarily for continued investments in the RVO program, a focused clinical study on diabetic retinopathy, but also for studies exploring the potential of ANXV treatment in cancer and sickle cell anemia.
RVO is one of the most common causes of vision loss, affecting more than 16 million patients worldwide. Currently, there is no effective treatment targeting the underlying causes of the disease, which is something that Stockholm-based Annexin Pharmaceuticals aims to change with its biological drug candidate ANXV.
A significant part of the company’s focus is on business development for the out-licensing of rights to ANXV and its ophthalmology program. Ongoing discussions with ophthalmologists and potential partners have recently led to the decision to expand ANXV’s use within ophthalmology. The drug candidate has also shown potential in the cancer field, in which the company has ongoing activities, as well as in other diseases such as sickle cell anemia.
Promising results strengthen ANXV’s potential
Annexin recently announced that the database for its Proof-of-Concept phase IIa study has been locked. The study evaluates ANXV for the treatment of patients with newly diagnosed RVO who have not been treated with the standard anti-VEGF therapy. The results are consistent with previous observations, showing that ANXV has a favourable safety profile without limiting side effects and clinically relevant signals of effect. Furthermore, ANXV’s expected mechanism of action has been confirmed through blood measurements in patients, where a reduction in its target molecule, phosphatidylserine, has been observed, while ANXV levels remained as expected. The study has thus achieved its primary objectives.
Fourteen out of 15 patients treated with ANXV have been followed up for four months. Based on visual acuity and retinal swelling, 12 of these patients have shown either improvement or a stable condition. Notably, seven patients were assessed as not needing any standard treatment with anti-VEGF injections, while an additional five required only a single injection. This represents a significant deviation from the standard treatment regimen in the U.S., where patients typically receive an average of five anti-VEGF injections within the first six months.
A crucial milestone for business development
Annexin’s goal is to enter a licensing agreement for the continued development of ANXV. The new results provide a stronger foundation for discussions with potential partners, some of whom have been waiting for the full data readout to conduct an in-depth evaluation.
Annexin’s CEO, Anders Haegerstrand, emphasises that the positive results create favourable conditions for discussions with potential licensing partners:
“We are very pleased with the results, which confirm ANXV’s potential, and the database now being locked, this significantly facilitates discussions with potential licensing partners as some have been waiting for complete dataset before the final evaluation of the project. We are seeing great interest and our goal is still closing a license agreement that both enables further development of ANXV and is advantageous from an ownership perspective.”
Rights issue to fund continued development in RVO and ANXV’s broader potential
In conjunction with the announcement of the confirmed phase IIa results, the company also disclosed its plans for a rights issue of approximately SEK 50 million. The capital raise is intended to fund preparations for a phase IIb study in RVO, including some further development of ANXV production, altogether strenghtening the possibility for an out-licensing agreement. To expand ANXV’s applications in ophthalmology and increase opportunities for future licensing agreements, the company is planning a limited Proof-of-Concept study in DR.
Discussions with potential partners and ophthalmologists have reinforced the value of clinical data in another eye disease — chronic vision problems caused by type 1 or type 2 diabetes, known as diabetic retinopathy (DR). Independent research links phosphatidylserine on blood cells to difficult-to-treat DR. Therefore, the company believes that ANXV could play a role in DR treatment if it can demonstrate a corresponding reduction in phosphatidylserine along with signals of efficacy, similar to what has been reported in RVO. As a result, the company is planning a focused and limited clinical Proof-of-Concept study in DR.
At the same time, the company has presented promising data from both in vitro and preliminary in vivo studies in the cancer field, justifying continued investment (for more information on the company’s cancer research, listen to this interview). In addition, Annexin intends to explore the potential of using ANXV in the treatment of sickle cell anemia (SCD), a debilitating and difficult-to-treat disease where phosphatidylserine is also considered a driving factor.
The subscription period for the rights issue will take place between March 7–24, 2025, provided that the company’s general meeting approves the decision on February 25.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
