Policy & Regulation
BioArctic reports product candidate SC0806 in phase 2 for treatment of patients with complete spinal cord injury
14 February 2019 -

BioArctic AB (STO:BIOAB), a Swedish research-based biopharmaceutical company, announced on Wednesday that the first patient in the second panel of the phase 1/2 study has now been treated with SC0806.

Reportedly, this implies that the study with the product candidate SC0806 for complete spinal cord injury has progressed into phase 2.

BioArctic has developed a new innovative treatment for patients with complete spinal cord injury. The product candidate SC0806 is a combination of a biodegradable medical device and a drug substance (FGF1).

According to the company, SC0806 is designed to support nerve regeneration across the injured area in the spinal cord. Due to the novelty of the treatment, patients have been included sequentially, in order to monitor the effect and safety.

Also, a safety evaluation of all the patients in the first panel has been performed and provided support to start the next panel. The first patient in the second panel has now received treatment with SC0806 and hereby the phase 2 part of the study has been initiated.

The inclusion of patients to the second of the three panels in the study is on-going, the company added.

Each panel consists of six patients receiving SC0806 and three control patients. In addition, an interim analysis of safety and efficacy of SC0806 in the first panel at 18 months is planned Q4 2019/Q1 2020.

BioArctic is focused on disease-modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer's disease and Parkinson's disease. The company also develops a potential treatment for Complete Spinal Cord Injury.

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