A randomized, open-label, Phase 2a study to assess the safety, pharmacodynamics, and pharmacokinetics of YAQ007 versus rifaximin in cirrhosis - PubMed
6 hours ago
- #ammonia reduction
- #cirrhosis
- #hepatic encephalopathy
- A Phase 2a study compared oral YAQ007 (L-Ornithine Phenylacetate) to rifaximin in 48 cirrhosis patients with a history of overt hepatic encephalopathy (HE).
- Patients were randomized to three YAQ007 dosing regimens (2 g TID, 4 g BID, 4 g TID) or rifaximin (550 mg BID) for 5 days as inpatients.
- YAQ007 at doses of 4 g BID and 4 g TID significantly reduced ammonia levels by day 5, while rifaximin did not show a significant effect.
- Urinary phenylacetylglutamine excretion increased significantly in all YAQ007 groups by day 5, indicating target engagement.
- Treatment-emergent adverse events occurred in 55.6% of YAQ007 patients and 41.7% of rifaximin patients, primarily mild gastrointestinal and neurological symptoms.
- The study supports further clinical evaluation of oral YAQ007 for ammonia reduction in cirrhosis and HE.