Currently, it is assessed in a multinational 350 patient phase II efficacy trial in ischemic stroke (AXIS 2). In a previously successfully completed phase IIa study (AXIS 1) it was demonstrated that AX200 is safe and well tolerated even in high doses and first signs of efficacy have been obtained. All primary and secondary endpoints were met.
Today, there is only one drug approved for treatment of ischemic stroke: tissue plasminogen activator (t-PA), a lytic agent which helps to dissolve the blood clots which cause an ischemic stroke. Treatment with t-PA should only be initiated within 4,5 hours after the onset of stroke symptoms. Only a limited number of stroke patients are currently eligible for this treatment.
In contrast to many previous treatment strategies, which addressed single mechanisms, AX200 acts beneficial on multiple levels, making it one of the most attractive candidates to treat stroke, a disease with a complex and quite personalized pathophysiology.
SYGNIS has built a comprehensive IP-strategy around the use of G-CSF in different neurological applications, with granted patent protection for stroke.
The proprietary sourcing of SYGNIS own G-CSF, AX200, is secured on the basis of an exclusive supply agreement with Dr. Reddy’s Laboratories for a broad spectrum of CNS indications with product characteristics fulfilling the highest standards and complying with regulatory requirements.