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2022-01-19

Annexin Pharmaceuticals AB: Approval of COVID19-study

Maastricht University Hospital receives approvals to start study with Annexin Pharmaceuticals drug candidate, ANXV, in patients with COVID19.

STOCKHOLM, SWEDEN (January 19, 2022) - Annexin Pharmaceuticals AB (publ) announces that its collaborators at Maastricht University Hospital, Maastricht, The Netherlands, have received approvals from the Dutch regulatory authority and Hospital committees to start a trial with ANXV (a recombinant human Annexin A5) in hospitalised COVID-19 patients.

The study follows upon Annexin Pharmaceutical's completed Phase 1 trial of ANXV in healthy volunteers. Annexin A5's potential in viral diseases has been highlighted in multiple high impact scientific publications and very recently Annexin A5 was directly proposed as a drug candidate to reduce the damage observed in the vascular system and lungs of patients with severe disease (see Plasma microparticles of intubated COVID-19 patients cause endothelial cell death, neutrophil adhesion and netosis, in a phosphatidylserine-dependent manner - PubMed (nih.gov) (https://pubmed.ncbi.nlm.nih.gov/34962643/).

This open-label, standard of care-controlled study will evaluate the safety, tolerability, pharmacokinetics and clinical efficacy potential of multiple intravenous doses of ANXV given to approx. 12 patients. The efficacy parameters to be investigated will include heart- and lung-function and markers of hyper-coagulation and -inflammation state. Dr Pieter van Paassen will act as Principal Investigator:

"I am really excited to welcome the fascinating protein Annexin A5 in the recombinant form back in its Alma Mater Maastricht, where it once was discovered by Prof. Chris Reutelingsperger in his biochemistry lab. The close collaboration with the Swedish team now enables us to explore whether ANXV inhibits the devastating amplifying feedback loop we observed in severe COVID-19, which really could be a gamechanger" (see Neutrophils and Contact Activation of Coagulation as Potential Drivers of COVID-19 - PubMed (nih.gov) (https://pubmed.ncbi.nlm.nih.gov/32946302/))

"We are glad to collaborate with Dr. van Paassen and his team taking this initial important step in evaluation of ANXV in patients. Annexin A5 has multiple potential roles in reducing the organ damage caused by the SARS-Cov-2 and potentially other viruses. Positive data will support continued clinical development in a potentially long-lasting pandemic as well as in other diseases associated with thrombosis and inflammation," said Dr Anna Frostegård, Chief Medical and Scientific Officer, Annexin Pharmaceuticals.

In this investigator-initiated study Annexin Pharmaceuticals will contribute ANXV, limited patient-related costs and drug-specific documentation and analyses.

About Annexin Pharmaceuticals AB (publ)

Annexin Pharmaceuticals AB is a world-leading biotechnology company in the Annexin A5 field for the treatment of various vascular diseases. The company's biological drug candidate ANXV - a human recombinant protein, Annexin A5 - is primarily intended for short term 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 ANXV.

The Company is based in Stockholm, Sweden and listed on Nasdaq First North Growth Market, under the ticker ANNX. Redeye is the company's Certified Adviser, email certifiedadviser@redeye.seor phone 08-121 576 90.

About University Hospital Maastricht
Maastricht UMC+ (MUMC+) is one of the Netherlands' eight university medical centres. It provides top-level referral and clinical care to a large part of the southeast of the Netherlands. Together with Maastricht University, it delivers scientific education, conducts translational and clinical research and provides patient care.

For further information please visit www.annexinpharma.com or contact CEO Anders Haegerstrand  at +46 0707 575 50 37.

The information was provided, under the above contact person's auspices, for publication on Januari 19, 2022 at 11.00 CET.

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