Gilles Avenard, co-founder and CEO of Actcor Biotech. (Photo credit: Acticor Biotech)
–
Acticor Biotech yesterday announced positive results from its Phase 1b/2a study, ACTIMIS, in patients with acute ischemic stroke. The opportunity to take stock with Gilles Avenard, co-founder and general manager of the biotech which has been listed since last November.
Boursorama: Can you give us an overview of the innovation developed by Acticor Biotech?
Gilles Avenard : Acticor is developing a monoclonal antibody (Fab) fragment directed against platelet glycoprotein 6 (GPVI). This biological medicinal product is intended for the treatment of cardiovascular emergencies and, in particular, ischemic stroke, in the acute phase, when the patient arrives at the hospital. This emergency treatment is intended to improve the effectiveness of standard management (reference treatment) which is thrombolysis (dissolution of the clot by injection of alteplase intravenously) associated or not with thrombectomy.
Boursorama: Apart from your product, glenzocimab, which is currently in development: what therapeutic solutions are available to patients suffering from an acute ischemic stroke today?
Gilles Avenard : Patients, when they arrive within 4 or 5 hours after the first symptom, can receive thrombolysis with alteplase. This thrombolysis can be completed, depending on the location of the clogged artery and its diameter, by a mechanical thrombectomy which consists of mounting a catheter in the clogged cerebral artery in order to aspirate the thrombus or to remove it. These are the only two treatments that can be used. This is the reference treatment.
Boursorama: What were the objectives of the ACTIMIS study and how are the results obtained interesting?
Gilles Avenard : The objectives of ACTIMIS were to demonstrate the good tolerance of glenzocimab associated with standard treatment, and in particular to show that glenzocimab did not cause more intracerebral haemorrhage, which is the main complication of stroke. This primary endpoint was associated with secondary endpoints seeking to highlight efficacy signals on clinical scores and imaging signs.
The results obtained show not only very good tolerance of the product but also a reduction in cerebral hemorrhages in the group treated with glenzocimab compared with the placebo. This result was not expected and it is the first time that a treatment has reduced bleeding. In addition, mortality is reduced by 3 times in the group treated with glenzocimab compared to the placebo; which is probably the consequence of the decrease in bleeding. Finally, if we consider the patients who have the greatest disability (clinical score 4 & 5) and the deceased patients, the number of patients is always reduced compared to the placebo group. Finally, it seems that the treatment is particularly effective in the oldest patients, the most severe and those treated by thrombectomy. For the doctors in charge of these patients, this is the first time that a new treatment has shown this type of results.
Boursorama: Why did you conduct the ACTIMIS study in combination with standard stroke treatment and not as monotherapy?
Gilles Avenard : For ethical reasons, in such a serious pathology, it is not possible to start studying a new treatment in place of reference treatments. It is therefore logical to see whether the new treatment associated with the reference treatment does better than the reference treatment associated with the placebo. Moreover, the claimed mechanism of action required, at least initially, to be associated with the reference treatment insofar as glenzocimab does not claim to “unclog” the artery. During development, it may be proposed to test glenzocimab as monotherapy in certain patient populations.
Boursorama: What development prospects are now open to glenzocimab following these very promising results?
Gilles Avenard : Faced with these results, we will continue to analyze the results more finely on other parameters such as the treatment schedule, certain categories of patients, etc. to learn all the lessons and, of course, publish these results in a journal. international. At the same time, we will review the current ACTISAVE and GREEN protocols in order to modify a certain number of parameters according to these results and to continue the development of this product in this indication with the best chance of success.
–
