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On November 22, 2021, Dannuo Pharmaceutical (Suzhou) Co.
, Ltd.
announced that it has successfully completed a phase II clinical trial of TNP-2092 capsules in the treatment of cirrhosis, hyperammonemia/hepatic encephalopathy and achieved positive results
.
TNP-2092 capsule is a new drug product in the clinical research and development stage.
It is used to treat liver cirrhosis, hepatic encephalopathy (HE) and diarrhea-type irritable bowel syndrome (IBS-D).
Dannuo Pharmaceutical owns its global intellectual property rights.
.
The study conducted by Dan Nuo Medicine is a randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety, effectiveness and pharmacokinetics of oral TNP-2092 capsules in patients with cirrhosis and hyperammonemia.
Kinetic characteristics
.
Hyperammonemia is highly correlated with hepatic encephalopathy.
Reducing the ammonia metabolism of the intestinal flora and reducing ammonia absorption are currently the main methods for the treatment and prevention of hepatic encephalopathy
.
This study enrolled 36 patients with hyperammonemia in liver cirrhosis and assigned them to three dose groups: 100 mg, 300 mg, and 600 mg, administered twice a day for 14 consecutive days, and all patients received appropriate background treatment Patients in each dose group were randomly assigned to receive TNP-2092 capsules or placebo treatment at a ratio of 2:1, and blood ammonia was tested regularly during the treatment
.
TNP-2092 capsules showed good safety in the study population.
Adverse events (TEAE) and TEAEs related to the study drug were not obvious between different dose groups and between the treatment group and the placebo group during the treatment period.
There were no serious adverse events (SAE) and no deaths in the TNP-2092 treatment group
.
As a local intestinal drug, the systemic exposure-area under the drug-time curve (AUC) of TNP-2092 capsules in patients with liver cirrhosis and hyperammonemia is still lower than 1% of the equal-dose injection, thus further ensuring its long-term use The safety tolerance
.
During the course of treatment, the ratio of the blood ammonia value of each treatment group of TNP-2092 capsules to the normal range (less than 47 micromol/l), and the decrease of blood ammonia after treatment compared with the baseline showed a dose-related increase trend.
Among them, the blood ammonia turnover rate and decrease value of the 600 mg treatment group are statistically significant differences compared with placebo (P value is less than 0.
05), and the effect of this dose on blood ammonia exceeds that of rifaxib in similar studies Ming's therapeutic effect
.
"Hepatic encephalopathy is a complex symptom of central nervous system dysfunction based on metabolic disorders caused by severe liver disease.
It occurs in approximately 30-45% of patients with liver cirrhosis, although these hepatic encephalopathy are mainly mild and occult symptoms.
Hepatic encephalopathy or grade I hepatic encephalopathy has varying degrees of impact on the quality of life of patients
.
At present, drugs for treating hepatic encephalopathy are limited, and there are unmet clinical needs
.
"One of the main investigators of this clinical trial, Jilin University Professor Niu Junqi, Director and Chief Physician of the Department of Liver Diseases of the First Hospital, said: "I am encouraged by the safety and effectiveness of TNP-2092 capsules in this study.
A safe and effective therapeutic drug
.
" "The early treatment and prevention of cirrhosis, hyperammonemia and hepatic encephalopathy are very important, and there are currently unmet needs in the choice of medications
.
The results of this phase II clinical trial are very encouraging.
It verifies the safety and effectiveness of the new drug TNP-2092 capsules in the treatment of cirrhosis and hyperammonemia, combined with the single-dose escalation and multiple-dose that have been completed in the previous period.
The results of studies on the effects of escalation and eating have laid the foundation for the further development of later clinical studies of TNP-2092 capsules in the treatment of liver cirrhosis, hyperammonemia and hepatic encephalopathy.
" One of the main investigators of this clinical trial, the First Hospital of Jilin University Professor Ding Yanhua, director of the Phase I Drug Clinical Trial Center and Chief Physician, said
.
"This clinical trial is an important proof of concept for TNP-2092 capsules in the treatment of cirrhotic hyperammonemia/hepatic encephalopathy.
We are very impressed by the results of this clinical trial.
I am very pleased to express my heartfelt gratitude to all patients, researchers, clinical research institutions, CROs, central laboratories and other partners who participated in this study.
" We are planning to initiate a late-stage clinical trial of TNP-2092 capsules for the treatment of cirrhotic hyperammonemia/hepatic encephalopathy, and to carry out a proof-of-concept study in patients with IBS-D
.
It is hoped that the successful development of TNP-2092 capsules can provide a better treatment option for patients with liver cirrhosis, hepatic encephalopathy and IBS-D in China and the world
.
"According to the results of the Global Burden of Disease (GBD) study published in the Lancet-Gastroenterology and Hepatology Journal in 2020, there are 10.
6 million patients with decompensated cirrhosis and 112 million patients with compensated cirrhosis worldwide.
, Leading to 1.
3 million deaths each year.
Hepatic encephalopathy occurs in about 30-45% of patients with cirrhosis, increasing the hospitalization rate, mortality and medical expenses of patients.
Studies have shown that the one-year survival rate of patients with hepatic encephalopathy is less than 50%
.
in recent years, the number of patients, prevalence, mortality and mortality rates have increased our cirrhosis, chronic liver disease and cirrhosis of the number of patients increased from nearly 700 million in 1990 to nearly 1,200 in 2016 Ten thousand people
.
At present, drugs for the treatment of liver cirrhosis and hepatic encephalopathy are very limited.
So far, the US FDA has only approved three products, neomycin, lactulose and rifaximin, and neomycin has been rarely used due to its serious adverse reactions
.
After rifaximin was approved for marketing in the United States in 2010, due to its good safety and effectiveness, it has become the main product for the prevention and treatment of hepatic encephalopathy in the United States.
However, rifaximin is a special formulation and adaptation for the treatment or prevention of hepatic encephalopathy.
Zheng has not yet been approved for listing in China
.
TNP-2092 developed by Dannuo Pharmaceutical is a multi-target coupling molecule that inhibits three important and clinically proven drug targets in bacteria: RNA polymerase, DNA gyrase and topoisomerase IV to exert antibacterial activity Therefore, it has strong antibacterial activity, low resistance frequency and good safety tolerance
.
TNP-2092 capsule is a drug that acts locally in the intestinal tract through oral administration.
It is used to regulate the intestinal microecology and treat hepatic encephalopathy and diarrheal irritable bowel syndrome related to intestinal microecological disorders
.
The product has similar antibacterial spectrum, intestinal specificity and regulation of intestinal microecology to rifaximin, and has a stronger inhibitory effect on intestinal ammonia-producing bacteria and a lower frequency of drug resistance
.
It is reported that the injection form of TNP-2092 is also in clinical development.
At present, international multi-center phase III clinical trials including China and the United States are being launched for the treatment of artificial joint infections (PJI) and acute bacterial skin and skin.
Structural infection (ABSSSI)
.
TNP-2092 has obtained the FDA Orphan Drug, Qualified Anti-infective Product (QIDP) and Fast Track qualification certification
.
About Danno Pharmaceuticals Danno Pharmaceuticals (Suzhou) Co.
, Ltd.
is a clinically demand-oriented company specializing in the research and development of differentiated new drug products.
It has a unique multi-target coupled molecular new drug research and development platform and new drugs with global intellectual property protection.
In the product development pipeline, many products have entered the later stage of clinical trials.
Target indications include medical device-related biofilm infection, Helicobacter pylori infection, cirrhosis, hepatic encephalopathy and diarrheal irritable bowel syndrome, etc.
, and are committed to solving The unmet clinical needs in these areas provide safe and effective treatment options for patients in China and even the world
.
End selected in the past to watch the blockbuster! The new crown special medicine is coming out after a long time, or it will be listed before the end of the year.
Stem cell therapy for hair loss has been launched.
The second case of AIDS patient who has recovered without treatment has been found in the world! How far is it from us to cure AIDS? Rewenhua Shenzhi Pharmaceutical and Tsinghua team achieved a new breakthrough in the research and development of new crown antibodies | Drug Targets| Healthy Life| Pharmaceutical News| Drug Inventory| Pharmaceutical Technology| Basic Research on Drug Side Effects/ Translational Medicine Leukemia| Lung Cancer| Gastric Cancer| Colorectal Cancer| Liver Cancer| Breast Cancer| Pancreatic Cancer| Cardiovascular Disease| Neurodegeneration Diseases | Intestinal microbial medical devices/biotechnological in vitro diagnostics | Medical devices | Bio-nano | 3D printing | Genetic testing | Single cell sequencing | Gene editing | Assisted reproduction | Artificial intelligence | Precision medicine policy Anticancer drugs | 4+7 belt quantity Procurement | Consumables | Filing System | Registrant System | Healthy China | New Essential Medicine Catalog | AI Medical Devices | Telemedicine | Same Equity Different Rights Market/Capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | Entrepreneurship Board| R&D Investment| Acquisitions| Market & Consumption
, Ltd.
announced that it has successfully completed a phase II clinical trial of TNP-2092 capsules in the treatment of cirrhosis, hyperammonemia/hepatic encephalopathy and achieved positive results
.
TNP-2092 capsule is a new drug product in the clinical research and development stage.
It is used to treat liver cirrhosis, hepatic encephalopathy (HE) and diarrhea-type irritable bowel syndrome (IBS-D).
Dannuo Pharmaceutical owns its global intellectual property rights.
.
The study conducted by Dan Nuo Medicine is a randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety, effectiveness and pharmacokinetics of oral TNP-2092 capsules in patients with cirrhosis and hyperammonemia.
Kinetic characteristics
.
Hyperammonemia is highly correlated with hepatic encephalopathy.
Reducing the ammonia metabolism of the intestinal flora and reducing ammonia absorption are currently the main methods for the treatment and prevention of hepatic encephalopathy
.
This study enrolled 36 patients with hyperammonemia in liver cirrhosis and assigned them to three dose groups: 100 mg, 300 mg, and 600 mg, administered twice a day for 14 consecutive days, and all patients received appropriate background treatment Patients in each dose group were randomly assigned to receive TNP-2092 capsules or placebo treatment at a ratio of 2:1, and blood ammonia was tested regularly during the treatment
.
TNP-2092 capsules showed good safety in the study population.
Adverse events (TEAE) and TEAEs related to the study drug were not obvious between different dose groups and between the treatment group and the placebo group during the treatment period.
There were no serious adverse events (SAE) and no deaths in the TNP-2092 treatment group
.
As a local intestinal drug, the systemic exposure-area under the drug-time curve (AUC) of TNP-2092 capsules in patients with liver cirrhosis and hyperammonemia is still lower than 1% of the equal-dose injection, thus further ensuring its long-term use The safety tolerance
.
During the course of treatment, the ratio of the blood ammonia value of each treatment group of TNP-2092 capsules to the normal range (less than 47 micromol/l), and the decrease of blood ammonia after treatment compared with the baseline showed a dose-related increase trend.
Among them, the blood ammonia turnover rate and decrease value of the 600 mg treatment group are statistically significant differences compared with placebo (P value is less than 0.
05), and the effect of this dose on blood ammonia exceeds that of rifaxib in similar studies Ming's therapeutic effect
.
"Hepatic encephalopathy is a complex symptom of central nervous system dysfunction based on metabolic disorders caused by severe liver disease.
It occurs in approximately 30-45% of patients with liver cirrhosis, although these hepatic encephalopathy are mainly mild and occult symptoms.
Hepatic encephalopathy or grade I hepatic encephalopathy has varying degrees of impact on the quality of life of patients
.
At present, drugs for treating hepatic encephalopathy are limited, and there are unmet clinical needs
.
"One of the main investigators of this clinical trial, Jilin University Professor Niu Junqi, Director and Chief Physician of the Department of Liver Diseases of the First Hospital, said: "I am encouraged by the safety and effectiveness of TNP-2092 capsules in this study.
A safe and effective therapeutic drug
.
" "The early treatment and prevention of cirrhosis, hyperammonemia and hepatic encephalopathy are very important, and there are currently unmet needs in the choice of medications
.
The results of this phase II clinical trial are very encouraging.
It verifies the safety and effectiveness of the new drug TNP-2092 capsules in the treatment of cirrhosis and hyperammonemia, combined with the single-dose escalation and multiple-dose that have been completed in the previous period.
The results of studies on the effects of escalation and eating have laid the foundation for the further development of later clinical studies of TNP-2092 capsules in the treatment of liver cirrhosis, hyperammonemia and hepatic encephalopathy.
" One of the main investigators of this clinical trial, the First Hospital of Jilin University Professor Ding Yanhua, director of the Phase I Drug Clinical Trial Center and Chief Physician, said
.
"This clinical trial is an important proof of concept for TNP-2092 capsules in the treatment of cirrhotic hyperammonemia/hepatic encephalopathy.
We are very impressed by the results of this clinical trial.
I am very pleased to express my heartfelt gratitude to all patients, researchers, clinical research institutions, CROs, central laboratories and other partners who participated in this study.
" We are planning to initiate a late-stage clinical trial of TNP-2092 capsules for the treatment of cirrhotic hyperammonemia/hepatic encephalopathy, and to carry out a proof-of-concept study in patients with IBS-D
.
It is hoped that the successful development of TNP-2092 capsules can provide a better treatment option for patients with liver cirrhosis, hepatic encephalopathy and IBS-D in China and the world
.
"According to the results of the Global Burden of Disease (GBD) study published in the Lancet-Gastroenterology and Hepatology Journal in 2020, there are 10.
6 million patients with decompensated cirrhosis and 112 million patients with compensated cirrhosis worldwide.
, Leading to 1.
3 million deaths each year.
Hepatic encephalopathy occurs in about 30-45% of patients with cirrhosis, increasing the hospitalization rate, mortality and medical expenses of patients.
Studies have shown that the one-year survival rate of patients with hepatic encephalopathy is less than 50%
.
in recent years, the number of patients, prevalence, mortality and mortality rates have increased our cirrhosis, chronic liver disease and cirrhosis of the number of patients increased from nearly 700 million in 1990 to nearly 1,200 in 2016 Ten thousand people
.
At present, drugs for the treatment of liver cirrhosis and hepatic encephalopathy are very limited.
So far, the US FDA has only approved three products, neomycin, lactulose and rifaximin, and neomycin has been rarely used due to its serious adverse reactions
.
After rifaximin was approved for marketing in the United States in 2010, due to its good safety and effectiveness, it has become the main product for the prevention and treatment of hepatic encephalopathy in the United States.
However, rifaximin is a special formulation and adaptation for the treatment or prevention of hepatic encephalopathy.
Zheng has not yet been approved for listing in China
.
TNP-2092 developed by Dannuo Pharmaceutical is a multi-target coupling molecule that inhibits three important and clinically proven drug targets in bacteria: RNA polymerase, DNA gyrase and topoisomerase IV to exert antibacterial activity Therefore, it has strong antibacterial activity, low resistance frequency and good safety tolerance
.
TNP-2092 capsule is a drug that acts locally in the intestinal tract through oral administration.
It is used to regulate the intestinal microecology and treat hepatic encephalopathy and diarrheal irritable bowel syndrome related to intestinal microecological disorders
.
The product has similar antibacterial spectrum, intestinal specificity and regulation of intestinal microecology to rifaximin, and has a stronger inhibitory effect on intestinal ammonia-producing bacteria and a lower frequency of drug resistance
.
It is reported that the injection form of TNP-2092 is also in clinical development.
At present, international multi-center phase III clinical trials including China and the United States are being launched for the treatment of artificial joint infections (PJI) and acute bacterial skin and skin.
Structural infection (ABSSSI)
.
TNP-2092 has obtained the FDA Orphan Drug, Qualified Anti-infective Product (QIDP) and Fast Track qualification certification
.
About Danno Pharmaceuticals Danno Pharmaceuticals (Suzhou) Co.
, Ltd.
is a clinically demand-oriented company specializing in the research and development of differentiated new drug products.
It has a unique multi-target coupled molecular new drug research and development platform and new drugs with global intellectual property protection.
In the product development pipeline, many products have entered the later stage of clinical trials.
Target indications include medical device-related biofilm infection, Helicobacter pylori infection, cirrhosis, hepatic encephalopathy and diarrheal irritable bowel syndrome, etc.
, and are committed to solving The unmet clinical needs in these areas provide safe and effective treatment options for patients in China and even the world
.
End selected in the past to watch the blockbuster! The new crown special medicine is coming out after a long time, or it will be listed before the end of the year.
Stem cell therapy for hair loss has been launched.
The second case of AIDS patient who has recovered without treatment has been found in the world! How far is it from us to cure AIDS? Rewenhua Shenzhi Pharmaceutical and Tsinghua team achieved a new breakthrough in the research and development of new crown antibodies | Drug Targets| Healthy Life| Pharmaceutical News| Drug Inventory| Pharmaceutical Technology| Basic Research on Drug Side Effects/ Translational Medicine Leukemia| Lung Cancer| Gastric Cancer| Colorectal Cancer| Liver Cancer| Breast Cancer| Pancreatic Cancer| Cardiovascular Disease| Neurodegeneration Diseases | Intestinal microbial medical devices/biotechnological in vitro diagnostics | Medical devices | Bio-nano | 3D printing | Genetic testing | Single cell sequencing | Gene editing | Assisted reproduction | Artificial intelligence | Precision medicine policy Anticancer drugs | 4+7 belt quantity Procurement | Consumables | Filing System | Registrant System | Healthy China | New Essential Medicine Catalog | AI Medical Devices | Telemedicine | Same Equity Different Rights Market/Capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | Entrepreneurship Board| R&D Investment| Acquisitions| Market & Consumption
