Quantum Genomics (PA:ALQGC) announced the results from the 34-patient Phase IIa study of QGC001 for the treatment of mild to moderate arterial hypertension. It showed a 2.7 mmHg placebo-adjusted reduction in the primary endpoint of ambulatory systolic blood pressure (SBP, p=0.16) and a 4.7 mmHg reduction in in-office SBP (p=0.15).
The p value improved to p=0.06 using a multivariate analysis, which is encouraging given the trial size, albeit slightly non-significant. Data from this study will be used in the design of the US-based Phase IIb hypertension trial, starting in H217.
Potential signal of efficacy despite suboptimal design
Although it is based on historical data and not head-to-head comparisons, the effect sizes seen in this clinical study were relatively low compared to those reported for approved hypertension medications, which produce placebo-adjusted changes in SBP in the range of 9-14 mmHg. However, the data on QGC001 are suggestive of activity and could potentially be improved with a more optimised clinical trial design.
To read the entire report please click on the pdf file below: