Annexin reports first imaging-study results in Retinal Vein Occlusion
Annexin Pharmaceuticals AB (“Annexin”) provides an update on its ongoing clinical study in patients with Retinal Vein Occlusion (RVO) using fluorescent labelled ANXV. Images in a case-report of a patient with RVO indicates site-specific accumulation of ANXV in the vessels affected by retinal vein occlusion.
Annexin is collaborating with TRACER Europe BV (“TRACER”) and the University Medical Center Groningen (“UMCG”) on an innovative clinical molecular imaging trial. The trial, also referred to as the SIGHT study, uses Annexin’s fluorescently labelled drug candidate ANXV to visualize the effect of ANXV in in patients with retinal vein occlusion (RVO). Recently, Dutch regulatory authorities also approved the inclusion of patients with diabetic retinopathy.
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 in RVO, prior to the emergence of complications.
The SIGHT study is managed by TRACER, a CRO specializing in molecular imaging techniques and fast in-human clinical trials, and is sponsored by the UMCG, one of the largest hospitals in the Netherlands. The trial will include up to 16 patients is expected to be completed by the end of 2023.
“When performing fluorescence imaging we observed a likely fluorescent signal in the vessels located at the site of the affected retinal area. This is supported by phosphatidylserine (PS) overexpression by red blood cells at the day of imaging. All together, these observations are indicative of site-specific accumulation of ANXV-800CW at the retinal vessels. In conclusion, these findings warrant continuation of the SIGHT study, including a dose escalation to a higher dose of ANXV-800CW in the subsequent cohort, to substantiate and confirm this promising observation”, say Dr. Yester Janssen, Director Clinical Operations at TRACER and Dr. Hendrikus Boersma, Principal Investigator of the SIGHT study and Hospital Pharmacist at the UMCG.,
“This is a first observation, and we expect more data at higher doses and in several patients. We are also pleased to see a confirmation that PS, the target for ANXV, was exposed on the surface of red blood cells in this patient, which is in line with previous studies suggesting PS as a potential cause of the disease”, says Anna Frostegård, MD, PhD, Chief Scientific and Medical Officer at Annexin.
The results from the trial are expected to be a confirmation that ANXV reaches its target and may lead to 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 is currently in Phase 2 clinical trial in the United States.
About Annexin Pharmaceuticals AB
Annexin Pharmaceuticals AB is a leading biotechnology company in the Annexin A5 field for the treatment of various diseases. The company’s biological drug candidate ANXV – a human recombinant protein, Annexin A5 – is primarily intended for treatment of patients with injuries and inflammation of the blood vessels, but also for cancer. The company has an extensive patent portfolio for the treatment of diseases with Annexin A5 and for production of Annexin A5.
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.
About TRACER Europe B.V.
TRACER is a Clinical Research Organization (CRO) specializing in 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 [email protected] or visit www.tracercro.com.
For further information, please contact:
Anders Haegerstrand, CEO, tel +4670 - 575 50 37
The information was submitted for publication at 08:30 on April 18, 2023