To all the shareholders and other interested parties in Annexin Pharmaceuticals,
2017 turned out to be an exciting and in many ways challenging year for Annexin Pharmaceuticals. I took over as CEO in mid-October and since then, I have worked hard to get to know the business, especially the development of our drug candidate ANXV – the recombinant human protein Annexin A5 – which we believe will be able to address the considerable treatment needs that exist within several cardiovascular diseases.
In October, two new members joined the Company’s Board of Directors: Carl-Fredrik Lindner (President) and Gisela Sitbon. Together with the Board, we have created a plan for a thorough strategic review of the development program, something we communicated just before Christmas. We expect to complete this work during the first quarter of 2018 and will thereafter inform the market about the Company’s development plan.
The large potential efficacy of ANXV in several therapeutic areas also carries the challenge to make the appropriate strategic decision regarding the choice of prioritized indications. As a consequence of the strategic review, the choice of the first prioritized indication and date of application for orphan drug designation in applicable cases will be dependent on the completion of this work.
Once the strategic review has been completed, we will also be able to make more precise statements regarding the financing needs of the company. However, we have already begun plans for a financing round and feel that the Company is in a good position to get additional funding through a new share issue.
In parallel with the strategic review, activities are fully under way to begin our first phase I clinical trial in 2018. Our current preclinical trials are in progress, and we plan to carry out the first clinical trial in human in such a way that the results will give us or a potential partner, a wide range of options for the choice of indication for future efficacy trials in phase II. The initial plan was to begin the first clinical trial already in 2017. Unfortunately, our contracting lab suffered from technical problems related to the infusion ports used, which has caused some delays. Today, we note that no further technical problems with infusion technology have occurred, and our ongoing preclinical safety trial is expected to be formally completed during the second quarter of 2018. This will be followed by an application to the Medical Products Agency for the initiation of clinical trials, and we expect the dosing of the first patient to take place during the third quarter.
ANXV could become a so-called first-in-class product, that is, the first of its kind in the market with a unique mechanism of action. ANXV looks for and repairs damaged cells in the body, builds a “shield” around the repaired cells and also has anti-inflammatory effects. This anti-inflammatory property opens up a whole new way of treating cardiovascular disease, which remains the category of diseases that causes the greatest number of deaths worldwide. In the fall of last year, positive results were presented within the field, which have led to a renewed interest in anti-inflammatory approaches to the treatment of cardiovascular disease.
Our assessment is that the entire field of cardiovascular disease will change in the future, and we see us as having a good chance of being at the forefront. This, as well as the ability to evaluate efficacy in many patient groups, feels very exciting. I would also like to emphasize the importance of already having an established and large-scale GMP production process in place for future clinical trials.
Together with the knowledgeable Annexin team, I feel tremendous motivation for the task of contributing to the development of new drugs for patients worldwide with large, unmet medical needs. I also look forward to realizing as much as possible of the fantastic potential I see in ANXV, and thereby delivering significant shareholder value.
Jamal El-Mosleh – CEO
Annexin Pharmaceuticals AB (publ)