Annexin receives FDA approval for phase II study
Earlier this week, Annexin Pharmaceuticals announced that they had received green light from FDA to begin a phase II clinical trial within RVO – a step that the company describes as the most important in its history. The FDA’s decision, which provides a quality seal for the company’s project, also means a shorter path to the application for phase II within additional indications.
RVO is the main focus
The main focus of Annexin Pharmaceuticals is retinal vein occlusion, RVO, one of the most common causes of blindness. Today’s treatment for the disease leaves a lot to desire. On the one hand, it means great discomfort for the patient because of regular needle pricks in the eye for at least six months, and, on the other hand, it has a relatively low effect as only 2 out of 10 patients regain their vision. Annexin’s drug candidate ANXV is instead given intravenously and for a short period, two aspects that the company considers to be of great importance from a patient perspective.
Results are expected this year
The company has now received the green light from the FDA to start a clinical phase II study with ANXV in patients with RVO in the US. The study aims to investigate safety, tolerability, and effects on patients’ vision and retinal function. The plan is for the placebo-controlled multiple-dose study to include about 20 patients from approximately 6–8 eye clinics, and results are expected later in 2022.
The choice of the US as a location for conducting the studies is strategically important for several reasons. The country is not only the largest potential market, over 50 percent, for ANXV. Furthermore, the US has several leading doctors, so-called Key Opinion Leaders, in the RVO area, and Annexin believes a study approval in the country provides a good opportunity to find licensees.
Significant stamp of approval
According to Annexin, the FDA’s decision represents the most important step in the company’s history. In addition to the quality stamp an FDA approval entails, as well as the fact that it is now possible in practical terms to start the phase II study, the announcement also means that the company has a much shorter route – both in terms of time and cost – to apply for phase II approval for studies in other indications in the US. This is because the information package for ANXV regarding animal studies, ANXV production, and the quality have already been approved.
CEO comments
BioStock contacted Annexin Pharmaceuticals CEO Anders Haegerstrand to find out more about the FDA approval and what it means for the company.
Anders, you describe the FDA approval as the biggest step in your history. Would you be able to develop around what approval means for Annexin?
– Choosing the US for the study is a bit like taking the bull by the horns as FDA’s assessment will still be the most important piece of the puzzle in the end. FDA regulates a market with over 300 million people and over 50 per cent of the value in RVO, in monetary terms, is there. I have previously discussed licensing deals with large companies, and I know how much the FDA’s positions weighs. We had a good interaction about a year ago and now we have gotten confirmation that we were thinking right.
When do you expect to be able to start patient recruitment for the phase II study?
– We are working to get ANXV and other material in place and to arrange formal start-up meetings at the eye clinics, something that couldn’t be done until now, after FDA’s announcement. I believe and hope for the first patient included within a month or so. We experience a great deal of interest from the eye clinics we engage in and maintaining the commitment and pace in the recruitment of patients for the study will be a key issue for us.
The approval also means a shorter path to approval for studies in other indications. Can you tell us something about what other indications you are looking for, for ANXV?
– We have received and do receive questions from doctors about being allowed to try ANXV on their patients, such as in covid-19 where we support a study in the Netherlands. We recently licensed the rights to use ANXV in the field of cancer, and this is of course an area that is very important and where ANXV has a unique point of action. I could list at least five diseases where there is data in animal models where ANXV has good effects, but not everything fits here.
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