Annexin Pharmaceuticals has decided to carry out its phase 2/proof of concept study in RVO in the US. The US is the largest market for RVO, and leading experts in the field can thereby participate in the study.
During the spring, the company had a dialogue with several pharmaceutical authorities, including the FDA, and in parallel worked with experts in the field to design and plan a phase 2/proof of concept study in patients with retinal vein occlusion (RVO). The company has chosen to carry out the study in the US in collaboration with a contract organisation within clinical research (CRO) that has extensive experience and expertise in eye diseases, and specifically of RVO. Annexin Pharmaceuticals is of the opinion that the RVO study in the US can be carried out with high efficiency.
The US is the largest market for drugs to treat RVO. Annexin Pharmaceuticals therefore sees great value in the FDA acting as the evaluating authority, and in being able to engage globally recognised so-called “key opinion leaders” in the field of eye diseases.
The company and its collaboration partner in the US plan to submit an application, an IND (Investigational New Drug), to the FDA in the autumn of 2021, based on the phase 1 data which the company expects to have available within approximately two months.
“The decision to carry out the next development phase with ANXV in the US is a natural step towards the most important market. We perceived the FDA as both interested and positive about our plans during the dialogue this spring. ANXV is a potential breakthrough product within RVO, and as such it is important to work with the leading authority and prominent doctors in order to gain trust, arouse the interest of potential partners, and accelerate the next stages towards registration and marketing “, says Anders Haegerstrand, CEO.
For further information, please contact:
Anders Haegerstrand, CEO
Phone: +46 70 575 50 37