The results from Annexin Pharmaceuticals’ phase-1 study show that the drug candidate ANXV was well tolerated by healthy volunteers. The Company thus proceeds with its preparations for a phase-2 study with the drug candidate in the United States.
During the year, the Company carried out a phase-1 study, which now has demonstrated that ANXV is well tolerated at the doses tested. No restrictive safety signals were detected. The results will form the basis of the future development of ANXV for the treatment of the disease retinal vein occlusion (RVO) as well as other diseases.
“It is very gratifying to see a satisfactory safety profile for ANXV in a phase-1 study. Some laboratory analyses and verification of data remain, but based on the clinical signs at dosage levels we believe may be effective in RVO and other indications, and according to the independent data and safety monitoring board that evaluates the results, ANXV was well tolerated. We look forward to beginning an intensive clinical development effort with ANXV in patients,” says Anna Frostegård, CSO/CMO at Annexin.
As previously disclosed, the Company intends to submit an application to carry out a phase-2 study in RVO to the US FDA in the fall of 2021. The study will be designed to establish Proof-of-Concept.
For further information, please contact:
Anders Haegerstrand, CEO, tel +46 70 575 50 37
The information was submitted for publication at 14.00 CET on 14 September 2021.
About Annexin Pharmaceuticals AB (publ)
Annexin Pharmaceuticals AB (publ) is a world-leading biotech company in the Annexin A5 field, for treatment of various cardiovascular diseases, which are currently the most common cause of death. The Company’s biological drug candidate ANXV – a human recombinant protein, Annexin A5 – is intended primarily for the acute treatment of patients with vascular damages and inflammation. The Company has a comprehensive patent portfolio for the treatment of diseases caused by vascular damage and inflammation. Annexin Pharmaceuticals has established and optimized a cell line for large-scale production of Annexin A5. The Company is based i Stockholm and is listed on Nasdaq First North Growth Market, short name ANNX. Redeye is the Company’s Certified Adviser. Tel. +46 (0) 8 121 576 90, email certifiedadviser [at] redeye [dot] se.