Hepatera LLC, a biotechnology company of Maxwell Biotech Group and a resident of the Skolkovo Foundation Biomed Cluster, has completed the patient recruitment for phase 2b clinical trials of Myrcludex B innovative medical drug.
Hepatera is implementing a clinical program for patients suffering from chronic viral hepatitis B with delta agent, which includes two clinical trials and extensive laboratory research intended for comprehensive study of the pharmacological activity of Myrcludex B innovative drug.
A clinical trial according to MYR 202 protocol involves the assessment of a viral load, activity of liver ferments and a histologic pattern for three dosages. The patients take Myrcludex B in a combination with a nucleotide analogue tenofovir to suppress the replication of hepatitis B virus. The trial includes 120 patients in 15 clinical centres of Russia and Germany. The active therapy stage duration will be 24 weeks.
The second clinical trial according to MYR 203 protocol assesses safety and anti-viral activity of various Myrcludex B dosages in combination with pegylated interferon ?-2a. The trial includes 60 Russian patients who will undergo an active therapy stage during 48 weeks.
Aleksandr Aleksandrov, Medical Director, Hepatera: “We do everything possible to speed up the market launch of Myrcludex B, awaited by the patients who suffer from the most severe form of viral hepatitis and have no treatment alternatives. Hepatera is implementing the world’s largest clinical program for the patients with this rare but very serious disease, and has recently completed the recruitment of 180 patients for two parallel trials.”
The program of clinical trials has been supported by the Skolkovo Foundation. A grant received in the end of 2015 allowed the company to focus its strategy of Myrcludex B studies on an orphan hepatitis B disease with delta agent, while the commercialization strategy switched to the accelerated market launch of the drug.
Kirill Kaem, VP, Executive Director of ?iomed Cluster, Skolkovo Foundation: “Hepatera, which is one of a few Russian startups to independently launch clinical trials both in Russia and Germany, has overcome all regulatory obstacles and quickly completed the patient recruitment, thus emphasizing a high market demand for the drug being developed. The Foundation and the patients’ community are eagerly waiting for the results of the clinical trials that will determine the further strategy for the commercialization of Myrcludex B innovative medical drug.”