Following the ADA update of the bacillus Calmette-Guerin (BCG) vaccine as a treatment for type 1 diabetes (T1D) earlier this month, leading data and analytics company GlobalData notes that BCG is well positioned as a repurposed drug to out-compete more expensive pipeline immunotherapy options if further studies continue to demonstrate similar efficacy results.

Samisha Khangaonkar, Pharma Analyst at GlobalData, comments: “Currently, the only treatment for T1D is the administration of exogenous insulin, and there is no approved treatment that actually addresses the underlying cause of T1D. In fact, key opinion leaders (KOLs) interviewed by GlobalData note that the lack of disease-modifying therapeutic is a critical unmet need in T1D. There are several therapeutics in the late-stage pipeline that aim to be disease modifying for T1D – such as Provention Bio’s teplizumab and Dompé Farmaceutici’s ladarixin – however, like BCG so far, these therapies do not negate the need for exogenous insulin.”

The MGH team presented data earlier this month from the ongoing five-year Phase II study that demonstrated several new findings. The study found that that over a period of three years, BCG can return gene expression in Tregs in type 1 diabetics to a pattern consistent with non-type 1 control subjects. In addition, T1D patients with an onset before 21 years of age had a faster response time and were able to achieve a greater change in HbA1c than adult onset T1D patients, showing a response at two years that matched the three-year response shown in older subjects.

Khangaonkar added: “While the long-term effects and greater population effects of BCG remain to be seen, one major advantage for BCG is its accessibility. As a vaccine that has been prevalent for nearly a century, it is likely that pricing will not be a barrier for patients who wish to take BCG. In addition, two doses of BCG, as part of the clinical trials, have been effective in patients with longstanding diabetes, whereas the late-stage pipeline is focusing their trials on the newly-diagnosed population. Accessibility and overall patient population are critical factors that make the presented results exciting and distinctive from other therapeutics in development.”