The devil could be in the detail for Idorsia’s hypertension win

 The problem with toplining clinical trial results in a press release is that crucial information needed to figure out whether a novel project has really hit the mark is often omitted. A case in point is Idorsia's declaration of success today for its J&J-partnered aprocitentan in the phase 3 Precision trial for resistant hypertension. Notably, the company did not disclose the absolute blood pressure reduction values for the three-part study. Both 12.5mg and 25mg aprocitentan doses significantly reduced systolic blood pressure versus placebo over four weeks, and this was maintained over 48 weeks, the Swiss biotech said. Investors will want to know whether the effect was as strong as seen in phase 2, and to see greater detail on safety, particularly oedema. Around 30% of patients experienced oedema in the phase 3 trial, and while most cases were mild to moderate there were two serious events in the higher 25mg dose group. Given the increased risk of cardiovascular complications in this patient population, confirmation is needed that this was not pulmonary oedema. Idorsia took the unusual step of delaying its investor call on the data until tomorrow, a move that could backfire if the details disappoint. 

Phase 3 aprocitentan Precision trial
Part 1	n=243	n=244	n=244
Dose	12.5mg	25mg	Placebo
Reduction in systolic BP after 4 weeks*	p<0.005	p<0.005
Adverse events	27.6%	36.7%	19.4%
Discontinuations after 4 weeks	2.5%	2.0%	0.8%
*against placebo. Source: company presentation.

 

The bar to beat: previously disclosed phase 2 data on aprocitentan
Dose/comparator	5mg	10mg	25mg	50mg	Placebo	Lisinopril
Systolic/diastolic BP reductions from baseline (at 8 weeks, mmHg)	10.3/6.3	15.0/9.9	18.5/12.0	15.1/10.0	7.7/4.9	12.8/8.4
Source: company presentation. https://www.evaluate.com/vantage/articles/news/trial-results-snippets/devil-could-be-detail-idorsias-hypertension-win