Heidelberg, January 14, 2009 – SYGNIS Pharma AG (Frankfurt: LIO; ISIN DE0005043509; Prime Standard) today provided an update on its preparations for the next trial with AX200 in acute stroke as well as highlighting the milestones achieved in 2008.
AX200: Preparations for Phase II study successfully completed
In the past year SYGNIS has made significant progress in the development of AX200 for acute stroke and in the preparation of the multinational Phase II efficacy study, for which patient enrolment is expected to commence in spring 2009. The AX200 material used in the clinical trial is produced by Dr. Reddy's Laboratories and has successfully passed pharmacological and toxicological testing. In addition, full technical and preclinical documentation (IMPD) has been submitted and approved by the German regulatory authority (BfArM). A clinical trial involving 36 healthy volunteers was completed in December in which the safety and tolerability of the new material was proven in the dose range planned for the upcoming Phase II efficacy study.
In parallel, under the leadership of Dr. Frank Rathgeb, who joined SYGNIS in April 2008 as Chief Medical Officer, the study protocol for the upcoming Phase II study has been finalized. SYGNIS has also been able to attract leading international stroke experts to serve on the trial’s Steering Committee. To date, over 80 stroke centres in 7 European countries have confirmed their interest in participating in the study which is scheduled to enrol approximately 350 patients.
Dr. Alfred Bach, SYGNIS CEO, commented: "We have now successfully completed our program for the preparation of the Phase II efficacy study and our technical and preclinical dossier has passed the first review by the German authority. We are now updating the documents for submission in all countries that will participate in this upcoming study which will be ongoing for about 18 months. Moreover we look back on a successful and key year for SYGNIS in which we have reached a number of strategic milestones alongside the further strengthening of our cash position.
Orphan Drug Designation for Amyotrophic Lateral Sclerosis and Spinal Cord Injury
Alongside its development in SYGNIS’ lead indication of acute stroke, AX200 has received Orphan Drug Designation for Amyotrophic Lateral Sclerosis as well as Spinal Cord Injury. In Spring 2009 SYGNIS will decide on the future development of AX200 in those indications and the next steps with respect to clinical development.
Capabilities increased significantly through acquisition of Amnestix and capital increase
In June, SYGNIS acquired Amnestix Inc., a US pioneer in neurogenomics and neurotherapeutics, with an important business relationship to the worldrenowned Translational Genomics Research Institute (TGen). Through the addition of Amnestix’ drug discovery capabilities to SYGNIS’ development expertise, the company has created a discovery engine that will fuel SYGNIS’ pipeline in the future with innovative projects for neurodegenerative diseases.
In November, SYGNIS raised €18.3m through a capital increase. The company issued 12,694,967 new shares from authorized capital and sold them at a price of €1.44 to existing shareholders. With the placement of the additional shares, SYGNIS’ total registered share capital increased from €28,563,676 to €41,258,643. As a result of the capital increase SYGNIS has access to approximately €27m (as of November 30, 2008) and considers itself well financed for the Phase II efficacy study and the further expansion of the product pipeline.