(CercleFinance.com) – The French biopharmaceutical company Acticor Biotech found itself in the spotlight last week after the success of a clinical trial in the emergency treatment of stroke. Gilles Avenard, the company’s general manager, discusses the implications of this success in an interview with Cercle Finance.
Cercle Finance: The stock price of your company jumped by more than 40% last week in the wake of the publication of positive clinical results in cerebrovascular accidents (CVA). How do you explain this enthusiasm on the part of the market?
Gilles Avenard: We, of course, welcome the market interest following the publication of the results of the phase 1/2 ACTIMIS clinical trial in the international scientific journal ‘The Lancet Neurology’. This publication by M. Mazighi et al. describes all the results obtained during the ACTIMIS study, already presented at international conferences, in particular the significant reduction in mortality and the reduction in intracerebral hemorrhages in the group of patients. treated with glenzocimab. ‘The Lancet Neurology’ is, for the scientific and medical community, a reference journal which highlights glenzocimab in the treatment of ischemic stroke, thus strengthening our confidence in the clinical value of our drug candidate. We are pleased to observe the market reaction to this encouraging data.
CF: A pivotal phase III study must now be initiated by the end of the year. When can we imagine your drug being placed on the market?
GA: The results of our ongoing phase 2/3 clinical study, ACTISAVE, currently evaluating glenzocimab in more than 400 patients in ischemic stroke, will be an important milestone. Results are expected in the second quarter of 2024 and will be essential to confirm the effectiveness of glenzocimab in these patients.
Based on these results and the recommendations of international experts in stroke, we plan to consult the EMA and the FDA again in 2024 to discuss the final registration phase, both in Europe and in the States. -United. Depending on the results and requests from the agencies, marketing is planned no later than 2028.
The interest shown by The Lancet Neurology and the community of experts in the field in our current results underlines the scientific seriousness of our approach, reinforcing our determination to advance glenzocimab towards a major therapeutic solution for patients.
CF: This good news puts you in an ideal situation as you consider tapping the market soon. We are talking about fundraising of at least 4.5 million euros. When do you plan to make the operation official?
GA: The significant interest from investors following the publication of these results in ‘The Lancet Neurology’ is a strong testimony to the growing confidence in the potential of glenzocimab.
Acticor Biotech is currently evaluating all strategic options to ensure adequate financing of its research and development activities. Although preliminary discussions have taken place, no official decision has yet been made regarding fundraising. We are aware of the importance of this approach and we will communicate with the market in due course.
Our objective remains to maintain a solid financial balance while allowing the continuation of our development program until the final stages of registration.
CF: With the good results recently obtained by Novo Nordisk in the areas of obesity and the prevention of cardiovascular accidents, investors have realized that certain molecules could have numerous functions. Although Acticor is not involved in the prevention of cardiovascular events, could your candidate have benefits in other indications?
GA: Although the primary scope of application for glenzocimab is focused on the treatment of ischemic stroke, we are open to exploring other potential indications to maximize the impact of our drug candidate.
A notable step forward in this direction is the LIBERATE clinical study, which obtained approval from the British regulatory agency (MHRA) at the end of last year. Carried out in partnership with the University of Birmingham, LIBERATE will evaluate the effectiveness of glenzocimab in the treatment of myocardial infarction. Based on solid foundations resulting from a long-standing collaboration, this phase 2b, randomized and double-blind study aims to evaluate the tolerance and effectiveness of glenzocimab compared to placebo in reducing the size of the infarct of the myocardium in more than 200 patients.
The positive results of this study could not only expand the scope of application of glenzocimab to cardiovascular emergencies, but also provide a new therapeutic perspective for patients facing this critical condition.
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