HAIXI PHARMA (02637) has reported that its Phase I clinical trial in China evaluating HX9428 for neovascular age-related macular degeneration (nAMD) has completed the 24-week treatment observation period. The ongoing Phase II dose-expansion study has also yielded interim clinical data.
The Phase I trial enrolled 15 nAMD patients across five dose cohorts ranging from 5 mg/QD to 40 mg/QD. Among these, 13 patients completed the full 24 weeks of treatment, including 10 who had previously received anti-VEGF therapy and three treatment-naive individuals. In the 13 patients who finished the 24-week regimen, best corrected visual acuity (BCVA) improved by an average of 5.2 letters from baseline, while central subfield thickness (CST) decreased by an average of 73.3μm, indicating favorable trends in both visual function and macular anatomical outcomes.
On the safety front, no dose-limiting toxicities were observed across any of the five dose levels, and the overall tolerability profile was favorable. Notably, no common gastrointestinal adverse events such as diarrhea, nausea, or vomiting were reported, nor was there any evidence of hair depigmentation. Regarding liver and kidney-related side effects, one case of elevated alanine aminotransferase (ALT) and one case of elevated aspartate aminotransferase (AST) were observed, both grade 1 and transient in nature. Hypertension-related adverse events were primarily seen in the higher dose groups, with one grade 3 event (a single systolic blood pressure reading of 160 mmHg) occurring in the 25 mg/QD cohort and two grade 3 events in the 40 mg/QD cohort; these were manageable through routine monitoring and antihypertensive medication. All adverse events emerged within the first three months of dosing, with no new safety signals observed during the three-to-six-month treatment window.
The Phase II dose-expansion study remains active. As of August 14, 2026, a total of 80 nAMD patients had been enrolled across the 5 mg/QD, 10 mg/QD, and 20 mg/QD dose groups, with approximately 78% having prior anti-VEGF exposure and 22% being treatment-naive. Of these, 45 patients had completed their week 13 visit, and 11 had finished the full 24-week treatment course. Interim results demonstrate continued improvement in both average BCVA and CST parameters with extended treatment duration. Among the 11 patients who completed 24 weeks, BCVA improved by an average of 5.4 letters from baseline, and CST decreased by an average of 72.5μm, aligning closely with the trends observed in the Phase I study. Given the limited number of patients who have reached the 24-week mark, these findings are considered preliminary and will require further validation as the study progresses and the sample size expands.
The safety profile in the Phase II study remains generally well-tolerated and consistent with Phase I observations. No common gastrointestinal adverse events have been reported, and hair depigmentation has not been observed. Other reported adverse events have predominantly been low-grade, including elevated blood pressure and fluctuations in liver, kidney, and metabolic laboratory parameters, with each individual event occurring at a rate below 10%. The company will continue to monitor all safety indicators closely and further assess the long-term benefit-risk profile of HX9428.