Celloram Inc., USA, proudly announces that Genfit, a leader in biopharmaceutical innovations targeting liver and inflammatory diseases, has unveiled promising preclinical data on CLM-022, licensed from Celloram, at the European Association for the Study of the Liver (EASL) International Liver CongressTM 2025. The event, held in Amsterdam, Netherlands, from May 7–10, highlighted CLM-022 as a dual inhibitor of the priming and activation steps of NLRP3 inflammasome, showcasing its potential as a groundbreaking treatment for acute and chronic inflammatory late-stage liver diseases, including acute-on-chronic liver failure (ACLF).
Leveraging nanomolar efficacy, CLM-022 effectively disrupts both the priming and activation steps of NLRP3 inflammasome activity, a key driver of liver inflammation. This innovative mechanism demonstrates significant therapeutic promise for addressing severe inflammatory conditions and immune dysregulation.
ACLF, a life-threatening syndrome arising from acute hepatic decompensation, leads to systemic organ failure and short-term mortality rates of 23% to 74% within 28 days. With few treatment options beyond liver transplantation—where 15% to 30% of patients die while waiting—the condition’s prevalence is projected to rise from 294,000 cases in 2021 across the US, EU4, and UK to 300,000 by 2036.1 Contributing factors include metabolic disorders like steatotic liver disease, diabetes, obesity, and aging populations. ACLF hospitalizations currently cost the US healthcare system $6.4 billion annually.2
Amid this urgent need, CLM-022 offers a beacon of hope. Preclinical studies presented by Genfit at EASL demonstrated the drug’s remarkable efficacy in inhibiting NLRP3 inflammasome priming and activation. In vitro, CLM-022 suppressed pro-inflammatory cytokines and pyroptosis in human peripheral blood mononuclear cells (PBMCs) and macrophages. In vivo studies revealed its potential, with oral administration protecting against acetaminophen-induced liver injury in mice by reducing hepatic damage and inflammasome activity. Additionally, intravenous administration in a rat endotoxemia model alleviated systemic inflammation and improved liver function.
“CLM-022’s dual mechanism of action and nanomolar efficacy mark it as a groundbreaking candidate for the treatment of inflammatory liver diseases,” said Dr. Tej Pareek, CEO of Celloram Inc., USA. “We are proud of Genfit’s remarkable progress and remain dedicated to supporting the continued advancement of CLM-022 as it moves closer to clinical development.” Dr. Seunghwan Lim, VP and Scientific Director of the CLM-022 program, emphasized its unique ability to target both the priming and activation stages of NLRP3 inflammasome activity, addressing critical unmet needs in the management of ACLF and advanced liver conditions.
Dr. Seong Jin Kim, Co-founder of Celloram, praised the partnership, stating, “Genfit’s leadership and commitment to innovation are driving this program toward clinical success.” Echoing these sentiments, Dr. John Letterio, Co-founder of Celloram, added, “The rising burden of ACLF makes the advancement of CLM-022 a significant milestone, offering a beacon of hope for patients battling these severe conditions.”
1 IQVIA® market research
2 Desai et al, Clin Transl Gastroenterol. (2019); Hirode et al JAMA Netw Open. (2020); Hernaez et al, J Hepatol. (2019); Mezzano et al, Gut (2022); Moreau et al, Gastroenterology. (2013)