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EMEA recommends Orphan Drug Designation for AX200

SYGNIS Pharma AG today announced that it has received a positive recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency for AX200 in the treatment of spinal cord injury.

Premises Sygnis Pharma AG (Photo: Sygnis)
A spinal cord injury (SCI) is damage or trauma to the spinal cord which interrupts communication of the brain with body regions below the site of injury. Spinal cord injuries are predominantly caused by accidents and, in the majority of cases, result in life-long loss of control of motor functions and sensation. After the primary injury to the spinal cord, a cascade of events leads to progressive loss of tissue which may further deteriorate the patient’s prognosis.

Spinal cord injuries most commonly affect young people in the fourth decade of life. Patients have an average life expectancy of more than 30 years after injury in which, alongside paralysis, they suffer from a large number of secondary conditions including chronic pain, circulatory problems or bladder dysfunction. There is a tremendous demand for novel therapies in view of the poor treatment options currently available.

Pre-clinical studies have shown that AX200 can counteract the processes leading to neuronal cell death. In addition, the compound has demonstrated a profound ability to foster neuronal regeneration and to support neuronal plasticity which facilitates functional recovery after SCI.

In April 2008, SYGNIS received Orphan Drug Designation from the European Commission for AX200 in the treatment of Amyotrophic Lateral Sclerosis.

Dr. Alfred Bach, CEO of SYGNIS Pharma AG, said: "We are pleased to announce the positive opinion of the EMEA which further validates our lead product AX200 as a promising neuroprotectant and recovery enhancer for the treatment of devastating CNS disorders. We continue to progress the development of AX200 in acute stroke and look forward to collaborating with the European Medicines Agency (EMEA) as we plan the initiation of clinical trials in ALS and SCI."
Source: Sygnis - 18.09.08
Website address: https://www.gesundheitsindustrie-bw.de/en/article/news/emea-recommends-orphan-drug-designation-for-ax200