The drug with the codenamed OFO7788 for the cirrhosis treatment is the latest development of Japanese scientists. Multistage clinical trials have yielded results showing that the drug stops inflammation in liver tissue, the process of necrotization of liver cells, and starts regeneration of hepatocytes.
This confirmed the assumption that the best cure for cirrhosis is one that not only treats the disease, but also helps the liver repair damage.
Is the efficacy of OFO7788 really that high?
What clinical experiments have been made?
In which cases do experts recommend taking the drug?
Are there any side effects?
In this article, we give detailed answers to these and other questions that patients face. `This article will be useful for those who have already encountered liver disease or want to help a loved ones overcome the disease.
The Medicines and Medical Devices Administration (PMDA) of Japan has registered the drug OFO7788 for the treatment of cirrhosis, liver fibrosis, other diseases of the gastrointestinal tract, and for the prevention of the development of complications. The efficacy of the drug has been proven with a numerous years of clinical trials.
After careful expert analysis of the data obtained, the PMDA has significantly expanded the list of indications for prescribing OFO7788, which proves its therapeutic effectiveness against many types of renal pathology, other diseases of the gastrointestinal tract, development of complications.
Laboratory and hardware diagnostics allowed to assess the drug performance in the treatment of the mentioned pathologies in the course of multistage clinical tests in dynamics. Although liver tissues show a slow recovery rate, which is a biological norm, reliable data on confident regeneration of healthy hepatocytes, partial or complete recovery of liver functionality can be obtained by the 6th month after completion of a full cycle of cirrhosis treatment from the three recommended courses.
OFO7788 is a fundamentally new treatment for cirrhosis and its complications, which is changing the modern medical perspective on the treatment of liver pathology. Patients have a chance to significantly improve their condition, minimize the risk of typical consequences and get rid of the disease, so now doctors can take a control of the course of the disease, stopping its development.
After tissue damage, the surviving liver cells increase in volume, filling the damaged clusters, but the dead hepatocytes do not regenerate. Even after treatment of hepatitis with cirrhosis, liver fibrosis, the organ cannot regain 100% functionality, and patients miss valuable time to effectively repair damaged tissues. After several years, 80% of patients with cirrhosis, liver fibrosis of the 3rd-4th degree have the following complications:
● hepatic insufficiency;
● fatty hepatosis;
● thrombocytopenia;
● hepatocellular carcinoma;
● malignant neoplasms of the intestine;
● malignant neoplasms of the stomach.
The active ingredient OFO7788 — immobilized hyaluronate-[beta]-N-acetylhexosaminidase-300 mg — reduces the degree of damage to hepatocytes and the activity of markers of necrosis — alanine aminotransferase and aspartataminotransferase, which is an important factor in stopping the damaging liver processes.
Innovative drug slows down the release of cytochrome C from mitochondria, apoptosis-inducing factors, prevents defragmentation of DNA molecule in cells, which leads to elimination of pathomorphological disorders in liver tissue, reduction of concentration of liver transaminases, bilirubin.
As a result of the substance action in the organ the inflammatory processes subside, the severity of asthenovegetative syndrome decreases.
The active substance — immobilized hyaluronate-endo-[beta]-N-acetylhexosaminidase — destroys fibrotic formation, so that the process of formation of scar changes in the liver stops, fibrosis foci regress, reducing or disappearing altogether.
The liver cells regenerate themselves, replacing the areas of former scarring. The liver regains its functionality and architectonics, pathological processes stop.
The rate and extent of tissue recovery depend on the type, stage of the disease. Liver cirrhosis with prognostic class A, B, C according to the Child-Pugh classification shows a positive response to OFO7788 therapy with rates of 82.5%, 79%, 42.5%, respectively. Such results of therapy have not yet been achieved by traditional therapeutic means.
Thus, OFO7788 is an innovative drug that helps to achieve the therapeutic effect of therapy and not just symptom reduction.
Multistage testing of OFO7788 was conducted in an international format, involving experts and medical schools in different countries. The expected results were confirmed by data from three phases of clinical trials on a large sample of subjects — about one thousand people.
Moreover, the results of clinical tests and laboratory dynamic studies of patients’ condition allowed us to significantly expand the list of indications to include not only all classes of liver cirrhosis and fibrosis, but also other hepatopathologies and gastrointestinal diseases.
Indications for prescription as determined by the experts at the beginning of the clinical trials:
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child-Pugh class A, B, C cirrhosis;
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congenital liver fibrosis;
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alcoholic, drug-induced, radiation-induced fibrosis of the 1st, 2nd, 3rd, 4th degree;
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fibrosis as a complication of other pathologies;
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congestive, obstructive fibrosis;
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venous dilation in the gastrointestinal tract;
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chronic alcoholic hepatitis;
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hepatitis of toxic, drug-induced origin;
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steatohepatitis;
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fatty hepatosis;
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banti disease;
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hepatorenal syndrome;
child-Pugh class A, B, C cirrhosis;
congenital liver fibrosis;
alcoholic, drug-induced, radiation-induced fibrosis of the 1st, 2nd, 3rd, 4th degree;
fibrosis as a complication of other pathologies;
congestive, obstructive fibrosis;
venous dilation in the gastrointestinal tract;
chronic alcoholic hepatitis;
hepatitis of toxic, drug-induced origin;
steatohepatitis;
fatty hepatosis;
banti disease;
hepatorenal syndrome;
Viral hepatitis B, C, with increased concentration of transminases.
A complementary list of indications for prescribing OFO7788:
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GI diseases with high risk of cancer;
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pancreonecrosis (namely treatment, not symptom reduction);
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pancreatitis (exactly treatment);
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Crohn’s disease (exactly treatment);
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recovery, elimination of risks of typical gastrointestinal disorders after chemotherapy;
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pancreatic malignancies of the 1st, 2nd degree in remission;
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need for prevention of malignant transformation of hepatocytes — hepatocellular carcinoma.
GI diseases with high risk of cancer;
pancreonecrosis (namely treatment, not symptom reduction);
pancreatitis (exactly treatment);
Crohn’s disease (exactly treatment);
recovery, elimination of risks of typical gastrointestinal disorders after chemotherapy;
pancreatic malignancies of the 1st, 2nd degree in remission;
need for prevention of malignant transformation of hepatocytes — hepatocellular carcinoma.
The list of indications is quite impressive, which is explained by high efficacy of the drug not only against hepatic pathology, but also against many other liver and gastrointestinal diseases, proven in clinical trials.
Non-toxicity, favorable safety profile, good tolerability of the drug allow to prescribe it for prevention and treatment in standard daily dosage to all patients, without dosage adjustment for elderly patients, patients with concomitant pathologies.
OFO7788 is the oral drug. It is available as a powder for suspension preparation, packed in dark glass vials.
Each vial contains 300 mg of the remedy.
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To make a fivefold dose of the drug, pour distilled or boiled cooled water into the bottle to 100 ml. The resulting suspension should be consumed within five days.
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Daily dose of the suspension is 20 ml, measured with a measuring spoon attached to the drug.
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To continue the course of treatment, prepare the next five doses of the suspension in a new bottle, and so on until the end of the course. One course of treatment is one month, or 30 days.
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For cirrhosis, treatment with OFO7788 is given in three courses per year with a 2-month break in between.
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For liver fibrosis up to 3rd degree, two courses per year are required with a pause of three months in between.
To make a fivefold dose of the drug, pour distilled or boiled cooled water into the bottle to 100 ml. The resulting suspension should be consumed within five days.
Daily dose of the suspension is 20 ml, measured with a measuring spoon attached to the drug.
To continue the course of treatment, prepare the next five doses of the suspension in a new bottle, and so on until the end of the course. One course of treatment is one month, or 30 days.
For cirrhosis, treatment with OFO7788 is given in three courses per year with a 2-month break in between.
For liver fibrosis up to 3rd degree, two courses per year are required with a pause of three months in between.
The medicine should be taken in the evening 1 hour before bedtime, excluding further food and drink, especially antacids, fruits, juices, sour drinks.
Side effects, contraindications
The drug OFO7788 cannot be used in the treatment of persons under 18 years of age.
It is also not recommended to use the drug during pregnancy or breastfeeding.
OFO7788 is contraindicated in:
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Individual intolerance to the product components;
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Autoimmune hepatitis;
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Hepatocellular carcinoma;
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decompensated liver cirrhosis of B and C class according to Child-Pugh;
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Viral hepatitis (before antiviral treatment and viral load control).
Individual intolerance to the product components;
Autoimmune hepatitis;
Hepatocellular carcinoma;
decompensated liver cirrhosis of B and C class according to Child-Pugh;
Viral hepatitis (before antiviral treatment and viral load control).
The drug should be prescribed with caution in:
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renal abnormalities, renal failure;
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hypercalcemia;
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nephrocalcinosis, nephrolithiasis;
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hypophosphatemia.
renal abnormalities, renal failure;
hypercalcemia;
nephrocalcinosis, nephrolithiasis;
hypophosphatemia.
Moderate adverse reactions were observed in 47% of subjects in clinical trials. There were no acute reactions, which indicates good tolerability of the drug.
The probable side effects include:
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allergic reactions: urticaria, bronchospasm, Quincke’s edema (probability — less than 1 in 10,000);
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neurotic reactions: insomnia, dizziness, nervous agitation, headache;
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gastrointestinal disorders: epigastric pain, nausea, vomiting, diarrhea, constipation;
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skin reactions: rash, skin itching.
allergic reactions: urticaria, bronchospasm, Quincke’s edema (probability — less than 1 in 10,000);
neurotic reactions: insomnia, dizziness, nervous agitation, headache;
gastrointestinal disorders: epigastric pain, nausea, vomiting, diarrhea, constipation;
skin reactions: rash, skin itching.
Researchers warn that prolonged overdosing of the drug can lead to encephalopathy.
In case of drug overdose, gastric lavage, use of saline laxatives and activated charcoal is necessary. Renal dysfunction after an overdose is an indication for prescription of dimercaptoyanthate, dimercaptopropanesulfonic acid preparations, and in case of increasing renal pathology hemodialysis is required.
The efficacy of OFO7788 was proven by multistage clinical trials on a large sample of subjects modeling various forms of liver damage. International experts confirmed the conclusions of the Japanese scientists, noting that this is the only drug of its kind that can not only stop pathological processes, but also stimulate cells to self-repair.
According to the results of the trials, the list of indications for prescribing the drug was significantly expanded, and the effectiveness was confirmed by laboratory and hardware diagnostic studies on a large sample of subjects with confirmed hepatic pathology.
In November 2022, OFO7788 was registered in Japan. Applications for registration of the drug have been filed in the U.S., the UAE, and many other countries.