Icosabutate Therapy Shows Promising Results in Treating NASH Patients with Type 2 Diabetes: ICONA Study
A recent study conducted by NorthSea Therapeutics B.V. has revealed promising results for the use of Icosabutate therapy in treating non-alcoholic steatohepatitis (NASH) patients with type 2 diabetes (T2D). The study, known as the ICONA study, aimed to assess the safety, tolerability, and efficacy of Icosabutate in NASH patients with fibrosis stages F1-F3.
The study found that patients treated with 600mg of Icosabutate showed a significant increase in the proportion of patients achieving NASH resolution without worsening fibrosis and a ≥2-point decrease in NAS compared to the placebo group (25.8% vs. 11.9%, p=0.03). While the overall study population did not reach statistical significance for the less stringent primary endpoint, the results were highly significant in patients with T2D.
In NASH patients with T2D, the 600mg dose of Icosabutate significantly increased the proportion of patients achieving NASH resolution without worsening fibrosis (35.5% vs. 8.7% placebo, p=0.02) and NASH resolution without worsening fibrosis and a ≥2-point decrease in NAS (35.5% vs. 4.3% placebo, p=0.007). Additionally, a significant improvement in fibrosis stage regression was observed in T2D patients treated with Icosabutate 600mg (31% treatment effect size, p=0.03) using AI technology (qFibrosis, Histoindex).
Based on these highly favorable results in T2D patients, NorthSea Therapeutics plans to pursue the development of Icosabutate as a treatment for NASH patients with T2D. In addition, the company also intends to advance two other clinical Phase 2 SEFA programs, including SEFA-1024 for severe hypertriglyceridemia (SHTG) and SEFA-6179 for the orphan indication IFALD (Intestinal Failure Associated Liver Disease).
The findings from the ICONA phase 2b study will be presented as an oral late-breaker at the AASLD Liver Meeting in Boston on November 13, 2023. The study enrolled 280 patients, with 178 meeting the histologic criteria for inclusion. Patients were randomized to receive once-daily, oral doses of Icosabutate 300mg, Icosabutate 600mg, or placebo for 52 weeks.
Overall, the results of the ICONA study suggest that Icosabutate therapy holds great promise as a potential treatment for NASH patients with type 2 diabetes. Icosabutate’s mechanism of action, which targets FFAR1 and FFAR4, provides a biological rationale for its observed effects in diabetic patients. These findings highlight the need for safe and effective therapies that target both inflammation and fibrosis in NASH patients with T2D.
The positive outcomes seen in this study support further clinical development of Icosabutate and the potential use of FFAR targeting as a therapeutic approach for diabetic NASH. While more research is needed, Icosabutate could potentially serve as a backbone oral therapy for this patient population, addressing the underlying metabolic dysfunction associated with NASH.
NorthSea Therapeutics is a biotech company focused on developing novel strategies for the treatment of NASH and other metabolic diseases. The company is supported by various investors and has licensed the rights to its lead compound, Icosabutate, which has shown positive results in previous clinical trials for hypertriglyceridemia and mixed dyslipidemia.
In conclusion, the ICONA study has demonstrated the potential of Icosabutate therapy in treating NASH patients with type 2 diabetes. The study’s findings highlight the need for new, effective treatments for this patient population and open the door for further development of Icosabutate as a promising therapy for NASH with T2D.