Avigen announced that it will refocus its research and drug development efforts.
"The company has made a strategic decision to discontinue its current Phase I trial for Coagulin-B and shift those resources into product candidates that more closely align with the company's new mission, in which it will expand and pursue its R&D efforts on serious and life threatening neurological disorders, including Parkinson's disease and chronic neuropathic pain," said Kenneth Chahine, Avigen's president and chief executive officer.
Dr. Chahine added, "While we are focusing on neurological disorders, we have every intention of preserving the large investment we have made in AAV gene therapy for hemophilia. We are currently exploring with our partners at Bayer HealthCare avenues to leverage the value we have created over the years in know-how, manufacturing, intellectual property and clinical expertise with the hope that our efforts will be a stepping stone to future hemophilia trials."
"However, we believe that focusing on serious neurological conditions, affecting millions of people worldwide, will make the best use of our current financial and scientific resources," Dr. Chahine said, adding, "Serious neurological disorders present unique opportunities for DNA-based drugs and our management team has both pre-clinical expertise as well as start-to-finish neurological drug development experience."
Avigen currently has two promising neurological product candidates. The first is AV201 for the treatment of Parkinson's disease. After extensive preclinical research, Avigen filed an Investigational New Drug ("IND") application seeking clearance to begin clinical testing of AV201. Avigen has responded to The Food and Drug Administration's ("FDA") request for further information and will be working with the FDA to facilitate an expeditious review and initiation of the phase I trial.
Following receipt of FDA clearance, the drug will initially be administered to individuals in the late stages of Parkinson's disease who have exhausted most of their therapeutic options. The second program is AV333 for the treatment of severe chronic pain, a very poorly managed condition resulting from a variety of disease states. AV333 represents an innovative approach to the treatment of unremitting pain, with demonstrated success in reversing neuropathic pain in established preclinical models.
Additionally, Avigen is actively seeking to broaden its portfolio of drug development candidates through an in-licensing program. This effort has identified several validated small molecule opportunities that are currently being investigated, some of which are currently in human clinical trials.