REMD Biotherapeutics recently announced the top-line results of its Phase II study of volagidemab, which aimed to determine whether volagidemab could decrease daily insulin requirements and improve glycemic control in Type 1 Diabetes (T1D patients). These results show the promise of adjunct therapeutics, as their potential impacts on lowering blood glucose levels, reducing patient insulin dose requirements, and reducing the risk of complications, will be imperative for T1D disease management, says GlobalData, a leading data and analytics company.

Samisha Khangaonkar, Pharma Analyst at GlobalData, comments: “Glycemic control is a key part of disease management in T1D. Key Opinion Leaders (KOLs) interviewed by GlobalData have noted that only 20-30% of T1D patients meet their glycemic targets and that the development of a treatment that would lower blood glucose to the target levels without causing hypoglycemic events is one of the largest unmet needs”.

Previously, Phase I trial results indicated that patients who received volagidemab were able to reduce daily insulin use by 26% (12 units) compared to those who received placebo. Participants received CGM for eight weeks after inpatient observation, and the average daily glucose assessed by CGM was 20–31mg/dL lower in volagidemab-treated patients compared to the placebo arm. Given the long-acting nature and persistent blood concentrations of volagidemab, it is likely that patients may be dosed once per week.

Khangaonkar continues: “Poor glycemic control is increasingly correlated with metabolic syndrome, and as a result poor weight management. GlobalData has found that 47% of T1D patients are overweight or obese, which means that weight loss will be a critical benchmark for volagidemab to meet, although it is not yet known if this will be investigated in future clinical trials.”

Currently, AstraZeneca’s Symlin (pramlintide) is the only approved adjunct therapeutic in the US for T1D. The T1D markets in Europe and Japan also include two sodium-glucose linked transporter (SGLT) inhibitors each. In Europe, AstraZeneca’s Forxiga (dapagliflozin) and Lexicon Therapeutics’ Zynquista (sotagliflozin) have been approved, while Forxiga and Astellas’ Suglat (ipragliflozin) have been approved in Japan. In the pipeline, vTv Therapeutics’ TTP399, an oral liver-selective glucokinase activator, has also been shown to improve HbA1c, reduce insulin doses, and not increase the risk of hypoglycemia or diabetic ketoacidosis.

Khangaonkar concludes: “Volagidemab is an injectable, which will make it difficult to penetrate the adjunct therapeutic market in a T1D patient population currently overwhelmed by injectable insulin treatments. Volagidemab will need to be affordable, assist with glycemic control (as an adjunctive therapy to insulin), confer weight loss in order for physicians to justify prescribing yet another injectable therapeutic, and allow volagidemab to compete against the oral TTP-399, which has a similar glycemic impact.

“GlobalData expects that REMD Biotherapeutics will focus on the US market, as SGLT inhibitors are not approved in the US, providing the company with an accessible market for its potential weekly injectable.”