A1M Pharma has successfully and according to plan conducted the first part of the company’s toxicology/safety studies with the pharmaceutical compound in the company’s candidate drug ROSGard.
In the studies, a maximum tolerated dose (MTD) has been established in two different animal models. These results will be used to establish the dosage levels to be used in the GLP-compliant toxicology studies.
On the way towards clinical studies within treatment of preeclampsia, A1M Pharma is conducting several preclinical toxicology/safety studies. The first part, which aims to establish the maximum tolerated dose in two different animal models, has now successfully been conducted within the communicated time frame.
“I am very pleased to say that we have conducted this first step within our toxicology/safety program in a good way and completely within the set time frame”, says A1M Pharma’s Head of Development Eddie Thordarson.
During the next part of the toxicology/safety studies, which has already been initiated, the goal is to collect data from repeated administration of the pharmaceutical compound. This step is expected to be completed during Q1 2017, after which the collected amount of data will form the basis of the GLP-compliant toxicology/safety studies that are scheduled for initiation during Q2 2017. Completed GLP-compliant toxicology/safety studies are required in order to initiate clinical studies.