B1140 is intended to treat Acute Ischemic Stroke for both the 0-4.5 hour treatment window and the 4.5-6 hour treatment window and its mechanism of action is the same as that of PUK for treating STEMI.
Results of the 0-4.5 hour treatment window study show: in terms of both 90-day Modified Rankin Scale (mRS; 0-1) and 24-hour National Institute of Health Stroke Scale (NIHSS), the efficacy data of the two B1140 doses were comparable to those of recombinant tissue plasminogen activator (rt-PA); B1140 was found to have a lower rate of serious adverse drug reaction (SADR) and a lower rate of all-cause mortality than rt-PA, with a similar number of 90-day all-cause mortality to rt-PA. In terms of bleeding rate within 90 days after thrombosis, the 35mg dose was reported with a lower rate than rt-PA, and the 50mg dose was comparable to rt-PA.
Results of the 4.5-6 hour treatment window study show: both 90-day mRS (0-1) and 24-hour NIHSS for B1140 demonstrated enhanced efficacy and safety.
Clinical Progress——Phase III