Acticor Biotech first-in-human clinical trial in healthy volunteers

Press Release ACTICOR BIOTECH FIRST-IN-HUMAN CLINICAL TRIAL IN HEALTHY VOLUNTEERS Paris, October 17 th , 2017 – Acticor Biotech, a clinical stage biotechnology company involved in the acute phase of thrombotic diseases, including s troke and myocardial infarction, today announced the agreement of Dutch Authorities for th e initiation of a phase I clinical trial in healthy volunteers with its drug candidate, ACT017. ACT017 is a humanized fragment of monoclonal antibody (Fab) directed against a platel et glycoprotein (GPVI) involved in thrombosis. The study is a randomized, double blind, placebo-controlled single escalating dose, conducted in the clinical research center of QPS, in The Netherl ands. On time with the development plan announced a year ago, the first cohort of volunteer s will be enrolled end of October 2017. The clinical study will include 48 subjects in 6 escala ting dose level cohorts, with each cohort consisting of 8 subjects: 6 on active and 2 on placebo at the following planned doses: 62,5 – 125 – 250 – 500 – 1 000 and 2 000 mg. The primary endpoint is to assess safety and tolera nce. Bleeding time, and parameters of haemostasis and coagulation will also be determined as well as pharmacokinetic and pharmacodynamics parameters. The results of this first-in-human study are expected for Q1 2018, and will be used to determine the appropriate ACT017 dosage for phase II studies. In preparation of the first phase II, positive data from a pharmacology study in primates associating ACT017 with rtPA (Actilyse ®), the only approved fibrinolytic drug for acute ischemic stroke, were obtained. This study demonstrated that there is no interference between ACT017 and rtPA given together compared with ACT017 or rtP A given alone. These results are paving the way for the first phase II in patients in the acute phase of ischemic stroke in association with rtPA. The company also reports positive safety data in a stroke animal model in primates. In the group treated with ACT017, 3 hours after the induction of cerebral thrombosis with ACT017 there is no additional intracerebral bleeding compared with the control group of primates. A decrease of the infarct volume in the cortex was also observed in the group treated 1 hour after the induction. Pr. Michael Mazighi, Neurologist, Hospital Laribois ière, Paris, France: “We consider that these results provide enough data to make the assumption that ACT017 will have a positive effect in human on micro-thrombosis downstream to proximal la rge vessel occlusion; and as a consequence with an expected benefit in the setting of acute ischemic stroke patients’ reperfusion.” About ACT017, the Therapeutic Candidate Acticor is developing ACT017, a humanized Antibody Fragment (Fab). The therapeutic candidate is directed against a novel target of major interes t, platelet glycoprotein VI (GPVI), and inhibits its action. Evidence of antithrombotic efficacy of ACT017 and safety of inhibition of GPVI have been established both ex vivo and in vivo . The target is involved in the growth of the throm bus, but not in physiological haemostasis. This limits the bleeding risk associated with its inhibition. About Acticor Biotech Acticor Biotech is a clinical stage biotechnology c ompany, spin-off of Inserm (U1148 – Bichat Hospital, Paris, France) founded late 2013, dedicat ed to developing an innovative treatment in the therapy of acute thrombotic diseases, a Fab dir ected against platelet glycoprotein GPVI. Acticor Biotech is built upon the expertise and the results of researches conducted by, the founders: Dr. Martine Jandrot-Perrus at INSERM Paris and Professor Philippe Billiald at Paris-Sud University. For more information, go to: https://acticor-biotech.com/ Contacts: Acticor Biotech: Gilles Avenard Chief Executive Officer [email protected] Media – NewCap: Annie-Florence Loyer [email protected] +33(0) 1 44 71 00 12 / +33(0) 6 88 20 35 59

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