The speciality pharmaceutical company Advicenne has announced that the US FDA has cleared the Investigational New Drug (IND) application submitted on behalf of ADV7103. ADV7103 is an investigational treatment for distal renal tubular acidosis, and the clearing of the application will allow a Phase 3 study of the drug to go ahead as planned. For more detailed information about this news, you can read the source press release at Business Wire by clicking here.
About Distal Renal Tubular Acidosis
Renal tubular acidosis (RTA) is a rare condition caused by the kidneys failing to excrete acids into the urine. As a result, people affected by RTA have blood that is too acidic, which, if left untreated, may cause reduced growth, kidney stones, bone disease, chronic kidney disease, and, in some cases, kidney failure.
There are several types of RTA. Classical distal RTA (dRTA) is typically associated with a defect in the ‘distal’ part of a tube in the kidney. The disorder can occur alone, or as one symptom of a condition that affects many different areas of the body, such as lupus or sickle cell anaemia.
About an Investigational New Drug Application (IND)
By law, a drug needs to have an approved marketing application before it can be transported across federal lines. However, many drug developers want to carry out studies of the drug in several states before applying for drug approval. To get around this, the developers can apply for an IND for the experimental drug. This can allow it to be legally transported across state lines without needing marketing approval. This means that, as in the case of ADV7103, an application for an IND has to be submitted and cleared before further clinical studies can take place.
For more information about INDs, you can click here to view the FDA’s information on them.
About the ARENA-2 Study
Following the news that the FDA had cleared the IND for ADV7103, Advicenne announced that they would be able to go ahead with their planned pivotal Phase 3 ARENA-2 study of ADV7103 in patients with dRTA.
ARENA-2 is a double-blind study that will compare ADV7103 to a placebo. Around forty patients are expected to take part in the study across the US. The study will look at the effectiveness and safety of the drug in preventing the development of metabolic acidosis (defined by serum bicarbonate levels) in patients aged between six months and sixty-five years old who have primary dRTA.
