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Today, there is good news
for the biomedical industry.
An innovative hypertension drug with excellent results in a phase 3 clinical trial can lower blood pressure in many patients whose blood pressure lowering drugs have not worked, and the effect can be maintained for nearly a year! Related news also pointed out that if this drug is finally approved, it will become the first blood pressure lowering drug based on a new mechanism in 30 years!
Worldwide, there are about 1.
3 billion people with hypertension, and 10% of them, or more than 100 million patients, have uncontrolled
blood pressure despite receiving at least three different types of antihypertensive drugs.
In addition to the genetic predisposition of patients, obesity, diabetes, sedentary time, mental stress, etc.
are also related
to the onset of hypertension.
In patients with hypertension, stable, long-term control of blood pressure is the primary goal
of treatment.
This is because long-term uncontrolled high blood pressure can cause damage to the heart and blood vessels, which in turn increases the risk
of heart disease, kidney failure, vascular dementia and stroke.
of heart disease, kidney failure, vascular dementia and stroke.
The investigational drug, aprocitentan, jointly developed by Idosia and Janssen, is an oral small molecule
that targets the dual endothelin receptor.
The endothelin information pathway, which controls vasoconstriction, has been found to be associated with hypertensive lesions, and is often found to be activated in those with refractory hypertension, although there is currently no therapy
to inhibit this pathway.
In addition to its potential to inhibit endothelin pathway, Aprocitentan has a low chance of drug-drug interaction with other drugs, which makes Aprocitentan a potential drug
for the treatment of patients with refractory hypertension.
.
▲Chemical structure and effect of Aprocitentan (Image source: Reference [2])
▲Chemical structure and effect of Aprocitentan (Image source: Reference [2])The Phase 3 trial of PRECISION consists of three parts, the first of which patients are randomized to receive different doses of aprocitentan or placebo
.
After 4 weeks, receive 12.
5
Patients treated with two different doses of aprocitentan, either mg or 25 mg, had significantly higher systolic blood pressure reductions than placebo, 3.
8 more so, respectively
mmHg (p=0.
0042) and 3.
7 mmHg (p=0.
0046).
A similar pattern was shown for diastolic blood pressure, receiving 12.
5 mg or 25 mg
Patients treated with aprocitentan had a 3.
9 mmHg and 4.
5 mmHg
higher drop in diastolic blood pressure than placebo.
5 Patients treated with two different doses of aprocitentan, mg or 25 mg, had significantly higher systolic blood pressure reductions than placebo.
In the second part of the trial, all patients received 25
mg of aprocitentan, the course of treatment is 32 weeks
.
The results of the trial showed that the reduction in systolic blood pressure was maintained
in the first group of patients treated with aprocitentan.
Patients who switched from placebo to aprocitentan rapidly achieved the same decrease in blood pressure within 2 weeks
.
.
In the third part of the trial, patients were re-randomized to receive a dose of 25
mg of aprocitentan or placebo therapy
.
After 4 weeks, systolic and diastolic blood pressure were significantly increased by 5.
8 in patients treated with placebo compared with those who continued aprocitentan
mmHg (p<0.
0001) and 5.
2 mmHg (p<0.
001).
8 in patients treated with placebo compared with those who continued aprocitentan mmHg (p<0.
0001) and 5.
2 mmHg (p<0.
001).
▲Aprocitentan clinical trial results (Image source: Reference [2])
▲Aprocitentan clinical trial results (Image source: Reference [2])In trials, the drug has also shown good tolerability
.
The most common adverse reaction associated with treatment (TEAE) in patients is mild to moderate fluid retention
retention), mostly controllable situations
.
The detailed data was also published today in
The Lancet, a leading medical journal.
According to a meta-analysis study of more than 300,000 people published last year in The Lancet, systolic blood pressure fell when systolic blood pressure dropped5, regardless of participants' previous cardiovascular history5
mmHg, its risk of major cardiovascular disease is reduced by about 10%! This has clinically important clinical implications
for hypertensive patients who are already at high risk of cardiovascular disease.
▲Safety results of Aprocitentan clinical trial (Image source: Reference [2])
▲Safety results of Aprocitentan clinical trial (Image source: Reference [2])Jean-Paul, CEO of Idorsia
Dr.
Clozel commented: "The results of our trial, published today in The Lancet, show that aprocitentan can reduce systolic and diastolic blood pressure in patients with refractory hypertension for more than 48 weeks
by targeting this new signaling pathway.
The paper also concluded that the drug may represent a new, effective and well-tolerated drug
for the treatment of refractory hypertension.
”
.
