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Initiation of clinical imaging study

Annexin Pharmaceuticals and Collaborators Initiate a Clinical Study in Patients with Retinal Vein Occlusion (RVO) Using Fluorescent Labelled ANXV.

STOCKHOLM, SWEDEN (September 29, 2021) – Annexin Pharmaceuticals AB (publ) (“Annexin”) announces that its collaborators have received approval from the Dutch regulatory authority to start an innovative clinical molecular imaging study of Annexin’s fluorescent labelled candidate drug ANXV in patients with venous occlusion in the retina (RVO). The trial is managed by TRACER, a CRO specialized in fast-track clinical imaging trials, and is being conducted at the University Medical Center Groningen (UMCG), one of the largest hospitals in the Netherlands.

ANXV holds the potential to rapidly improve retinal blood supply and reduce the risk of blindness and provide other short-term and long-term benefits in the acute setting, prior to the emergence of complications.

In the approved clinical imaging study, by using state-of-the-art clinical NIR fluorescent camera systems, ANXV will be traced in the patient´s eye over time. The results can serve as a confirmation of the specificity of the drug and may lead to e.g. refinement in selection of patients with RVO in future clinical trials.

ANXV has been found safe and tolerable in healthy volunteers in a Phase 1 study and a Phase 2 clinical study in RVO patients is planned to be initiated in the United States later this year.

About Annexin Pharmaceuticals AB (publ)

Annexin Pharmaceuticals AB is a world-leading biotechnology company in the Annexin A5 area, for the treatment of various cardiovascular diseases, which today is the most common cause of death. The company’s biological drug candidate ANXV – a human recombinant protein, Annexin A5 – is primarily intended for the acute treatment of patients with injuries and inflammation of the blood vessels. The company has an extensive patent portfolio for the treatment of diseases that occur due to the damage and inflammation of the blood vessels. Annexin pharmaceuticals has established and optimized a cell line for large-scale production of Annexin A5.

The Company is based in Stockholm and listed on Nasdaq First Growth Market, ticker ANNX. Redeye is the company´s Certified Adviser, email certifiedadviser@redeye.se or phone      +46 (0) 8-121 576 90.

About TRACER B.V.

TRACER B.V. is a Clinical Research Organization (CRO) specializing in fast-track solutions for the clinical testing of innovative biologic therapies as well as advanced nuclear and optical molecular imaging methodologies. TRACER provides its clients with the expertise, infrastructure and capacity to generate fast accurate first-in-human clinical data. This data shows whether the tested compound reaches the target tissue in humans, making clinical trials more cost efficient and products reach the market faster. For more information contact info@tracercro.com or visit www.tracercro.com.

About University Medical Center Groningen
The University Medical Center Groningen (UMCG) is one of the largest hospitals in the Netherlands. Its more than 12,000 employees work together on care, research, training and education with the common goal: building the future of health. Through innovative and sound research UMCG aims to understand mechanisms of disease; to push borders for diagnostics and treatment; and to help build a network for sustainable health. All of its research focuses on Healthy Aging. Talent development and state-of-the-art infrastructure are of paramount importance to UMCG.

For further information please visit www.annexinpharma.com or contact Anders Haegerstrand (CEO) at +46 (0) 707-575 50 37.

The information was provided, under the above contact person's auspices, for publication on 29 September 2021 at 09.00 CET.