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▎Editor of WuXi AppTec Content Team On July 13, 2021, Hepion Pharmaceuticals announced that in patients with non-alcoholic steatohepatitis (NASH), it is investigating the Phase 2a AMBITION clinical trial of CRV431, a novel cyclophilins inhibitor The trial achieved a positive top-line result, reaching all the primary endpoints of the trial
.
This randomized single-blind, multi-center, placebo-controlled Phase 2a clinical trial aims to study the safety, tolerability and drug resistance of CRV431 in NASH patients with moderate (F2) or advanced (F3) liver fibrosis.
Generation Kinetics (PK)
.
In the first 28 days of the test, the test group was given 75 mg or 225 mg of oral CRV431 once a day, followed by a 14-day safety observation period
.
The main evaluation method of the trial is the incidence of safety and tolerability events of CRV431 compared with the placebo group
.
Previous studies have shown that the reduction of alanine aminotransferase (ALT) in patients' serum may be a surrogate indicator for histological improvement of NASH
.
In the trial, compared with the placebo group, the two doses of CRV431 administered once a day both showed a statistically significant reduction in ALT
.
Within 28 days, the patient's serum ALT dropped by 10%-15%
.
The detailed results are shown in the following table: ▲Compared with the placebo group in the trial, the CRV431 cohort of different doses all showed a statistically significant decrease in ALT (picture source: reference [1]) The trial results also showed that the two studies All doses of CRV431 were well tolerated, no serious adverse events (SAE) occurred, and the few observed adverse events (AE) were mostly mild and not related to the study drug
.
The drug reaches its maximum concentration within 2 hours after administration, and the effective half-life is about 30 hours, so it supports a single daily administration
.
The trial successfully determined the drug dosage range for the upcoming Phase 2b trial
.
Hepion plans to open a large phase 2b clinical trial later this year, which will evaluate the efficacy and safety of CRV431 in NASH subjects with advanced fibrosis confirmed by biopsy
.
CRV431 is an innovative oral drug candidate targeting NASH and viral hepatitis to induce liver disease.
It is currently in the clinical stage
.
So far, CRV431 has shown good safety characteristics in all animal and clinical studies
.
Due to its many different mechanisms of action and its accumulation in the liver (concentration 5 times higher than in the blood), CRV431 has shown therapeutic potential in NASH and hepatitis B virus (HBV) replication animal models
.
▲ Mechanism of action of CRV431 (picture source: Hepion's official website) Dr.
Robert Foster, CEO of Hepion, said, “CRV431 is widely obtained by the liver after oral administration, and its potential for treating liver disease depends to a large extent on liver function
.
The liver function of NASH patients decreases with the development of the disease, so it is very important to design a trial to clarify the safety, tolerability and pharmacokinetic effects of CRV431 in NASH patients
.
In addition, this trial provides us with an opportunity to explore the potential efficacy of CRV431 in NASH subjects
.
We will continue to analyze other data from this trial and hope to get more additional data in the short term
.
"Reference: [1] Hepion Pharmaceuticals Announces Positive Topline Data from Phase 2a'AMBITION' NASH Trial; All Primary Endpoints Achieved.
Retrieved July 13, 2021, from https:// 07/13/2261922/0/en/Hepion-Pharmaceuticals-Announces-Positive-Topline-Data-from-Phase-2a-AMBITION-NASH-Trial-All-Primary-Endpoints-Achieved.
html Note: This article aims to introduce medicine Health research progress is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
.
This randomized single-blind, multi-center, placebo-controlled Phase 2a clinical trial aims to study the safety, tolerability and drug resistance of CRV431 in NASH patients with moderate (F2) or advanced (F3) liver fibrosis.
Generation Kinetics (PK)
.
In the first 28 days of the test, the test group was given 75 mg or 225 mg of oral CRV431 once a day, followed by a 14-day safety observation period
.
The main evaluation method of the trial is the incidence of safety and tolerability events of CRV431 compared with the placebo group
.
Previous studies have shown that the reduction of alanine aminotransferase (ALT) in patients' serum may be a surrogate indicator for histological improvement of NASH
.
In the trial, compared with the placebo group, the two doses of CRV431 administered once a day both showed a statistically significant reduction in ALT
.
Within 28 days, the patient's serum ALT dropped by 10%-15%
.
The detailed results are shown in the following table: ▲Compared with the placebo group in the trial, the CRV431 cohort of different doses all showed a statistically significant decrease in ALT (picture source: reference [1]) The trial results also showed that the two studies All doses of CRV431 were well tolerated, no serious adverse events (SAE) occurred, and the few observed adverse events (AE) were mostly mild and not related to the study drug
.
The drug reaches its maximum concentration within 2 hours after administration, and the effective half-life is about 30 hours, so it supports a single daily administration
.
The trial successfully determined the drug dosage range for the upcoming Phase 2b trial
.
Hepion plans to open a large phase 2b clinical trial later this year, which will evaluate the efficacy and safety of CRV431 in NASH subjects with advanced fibrosis confirmed by biopsy
.
CRV431 is an innovative oral drug candidate targeting NASH and viral hepatitis to induce liver disease.
It is currently in the clinical stage
.
So far, CRV431 has shown good safety characteristics in all animal and clinical studies
.
Due to its many different mechanisms of action and its accumulation in the liver (concentration 5 times higher than in the blood), CRV431 has shown therapeutic potential in NASH and hepatitis B virus (HBV) replication animal models
.
▲ Mechanism of action of CRV431 (picture source: Hepion's official website) Dr.
Robert Foster, CEO of Hepion, said, “CRV431 is widely obtained by the liver after oral administration, and its potential for treating liver disease depends to a large extent on liver function
.
The liver function of NASH patients decreases with the development of the disease, so it is very important to design a trial to clarify the safety, tolerability and pharmacokinetic effects of CRV431 in NASH patients
.
In addition, this trial provides us with an opportunity to explore the potential efficacy of CRV431 in NASH subjects
.
We will continue to analyze other data from this trial and hope to get more additional data in the short term
.
"Reference: [1] Hepion Pharmaceuticals Announces Positive Topline Data from Phase 2a'AMBITION' NASH Trial; All Primary Endpoints Achieved.
Retrieved July 13, 2021, from https:// 07/13/2261922/0/en/Hepion-Pharmaceuticals-Announces-Positive-Topline-Data-from-Phase-2a-AMBITION-NASH-Trial-All-Primary-Endpoints-Achieved.
html Note: This article aims to introduce medicine Health research progress is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
