According to a story from BioSpace, the pharmaceutical company Advicenne has been granted clearance from Health Canada’s Office of Clinical Trial to extend its Phase III clinical trial, which is testing the company’s investigational therapy ADV7103 as a potential treatment for renal tubular acidosis. Advicenne specializes in the development of child friendly treatments for orphan neurological and kidney diseases. The company has also received a similar clearance for the extension from the US Food and Drug Administration (FDA) last month.
About Renal Tubular Acidosis
Renal tubular acidosis is a rare condition in which acid begins to accumulate in the body due to malfunction of the kidneys that prevents them from acidifying urine. There are several different types of this condition and all them have slightly different causal mechanisms; genes play a role in some cases, but it can also occur as an autoimmune disease. Symptoms of renal tubular acidosis include acidemia, bone softening (leading to rickets or osteomalacia), urinary stones, hypokalemia, hypocalcemia, Sjogren’s syndrome, and calcium deposits in the kidneys (kidney stones). These complications can eventually lead to issues with kidney function and even kidney failure. There are around 20,000 patients in the US and 30,000 in Europe. There is a serious need for better treatment options for this condition. To learn more about renal tubular acidosis, click here.
About the Phase III Trial
The Phase III trial is expected to utilize around 40 patients with renal tubular acidosis. The trial will measure the safety and effectiveness of ADV7103 as a potential treatment for this condition in both children and adults. The trial will include patients from both the US and Canada. This experimental drug has already displayed promising results in the similar trial which took place the Europe. Advicenne also plans to test ADV7103 as a treatment for a disease that is related to renal tubular acidosis, cystinuria.
Given the current outlook of data and the pace of trials, the company hopes that ADV7103 will become commercially available in the EU in 2020 and in the US by 2021.
