Table 1.

A summary of clinical studies investigating namodenoson in MASLD/MASH and HCC.

Author Reference	Disease	Phase, Study Design, n, Key Endpoints	Key Findings
Safadi et al. [15]	MASLD with or without MASH	Phase 2, randomized (1:1:1) double blind study of namodenoson 12.5 mg BID (n = 21) or 25 mg BID (n = 19) vs. placebo (n = 20). Main endpoints: ALT after 12 weeks, safety.	Change from baseline in serum ALT levels over time: A trend towards significance at Week 12 for namodenoson 25 mg BID vs. placebo (p = 0.066). ALT normalization rate: A statistically significant difference at Week 16, for 25 mg BID vs. placebo (p = 0.038). Safety: Namodenoson was well tolerated
Stemmer et al. [13]	Advanced unresectable HCC	Phase 1/2 open-label dose-escalation study (n = 18, 6 at each dose level: 1, 5, and 25 mg BID). Main endpoint: Safety	Safety: Namodenoson was not associated with dose-limiting toxicities or serious drug-related AEs.
Stemmer et al. [14]	HCC CPB patients who either progressed on, or could not tolerate, prior sorafenib treatment.	Phase 2, randomized (2:1) double blind study of namodenoson 25 mg BID (n = 50) vs. placebo (n = 28). Main endpoint: OS in the ITT population.	OS—ITT: Primary endpoint was not met. Median OS, 4.1 and 4.3 months for namodenoson and placebo, respectively; HR, 0.82; 95% CI, 0.49–1.38; p = 0.46. 12-month OS in patients with Child Pugh score of 7 (n = 56): 44% and 18%, for namodenoson and placebo, respectively; p = 0.028. Safety: Namodenoson was well tolerated

AE, adverse event; ALT, alanine transaminase; CI, confidence interval; CPB, Child-Pugh class B; HCC, hepatocellular carcinoma; HR, hazard ratio; ITT, intention-to-treat; MASH, metabolic dysfunction-associated steatohepatitis; MASLD, metabolic dysfunction-associated steatohepatitis; OS, overall survival.