AVM Biotechnology is set to study its small molecule, AVM0703, for reversing Type 1 diabetes (T1D) with the receipt of a Phase II Small Business Innovation Research (SBIR) award of $1.6m from the National Institute of Diabetes and Digestive Kidney Disease (NIDDK).

The latest grant will permit the company to carry out further research into using AVM0703 as a single agent and as a combination treatment for reversing recent onset and established T1D.

This Phase II project will advance the preclinical research, to speed up data acquisition that will facilitate in seeking an investigational new drug application (IND).

Subsequently, this move will aid in launching clinical trials of the therapy. 

The award will be provided over a period of two years and the second-year payment is contingent to fund availability and the study’s satisfactory advancement.

The initial goal of the programme is to carry out a preclinical dose-finding and mechanism of action (MOA) study in three settings including pre-diabetic, new-onset and established diabetes.

These findings will be leveraged to establish the targeted dose to be used in a pivotal efficacy study to reverse new-onset and established diabetes. 

AVM0703 is expected to complement other immunotherapies in individuals who do not show remission, permitting a broader patient population to attain insulin independence.

The latest NIDDK grant comes after the company obtained a Phase I grant in 2019 to study targeted lympho-ablation as a substitute for treating T1D. 

According to data from this preclinical research programme, in 55% of treated mice, AVM0703 was demonstrated to substantially delay T1D onset by 20-31 weeks.

Furthermore, the treatment averted the onset of diabetes in the other 45% of mice. 

T1D is an autoimmune disease that causes damage to the insulin-making beta cells in the pancreas.