| | | | | | mg treatment group was 20.83%, 21.74% and 16.67%, respectively, with no statistical significance.
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17 patients experienced SAEs, but none were drug-related. The incidenceimmunosuppressive treatment for CTD and the anti-fibrosis treatment for ILD, which can effectively prevent or even reverse the progression of adverse drug reactions (“ADRs”)ILD lesion and protect the pulmonary function of patients. Recommended immunological drugs include cyclophosphamide, mycophenolate mofetil and azathioprine. Anti-fibrosis treatment methods vary with different types of CTD-related ILD in the placebo group, 400 mg and 600 mg treatment groups was 41.67%, 29.17% and 45.83%, respectively, with no statistical difference between the three groups. The incidence of rash in the treatment groups was statistically different from that in the placebo group and was present in allterms of the 600 mgtiming, drug selection, dosage and treatment groupsduration. Recommended anti-fibrosis drugs include pirfenidone and nintedanib.
Pirfenidone is an antifibrotic agent with an incidenceanti-inflammatory properties, including inhibition of 20.83%. The common ADRs included nausea (12.5%proinflammatory cytokines and inhibition of inflammatory cell proliferation. Despite the differences in eachtheir clinical presentation, IPF, SSc-ILD and DM-ILD share some overlapping pathogenic mechanisms, including injury to structural cells, fibroblast activation, myofibroblast accumulation, expression of fibrogenic cytokines and growth factors and progressive ILD. Based on the 400 mg treatment groupresults of pirfenidone’s preclinical studies, we are evaluating its efficacy on patients with SSc-ILD and 600 mg treatment group), photosensitivity (4.17%DM-ILD in the 400 mg treatment group and 12.5% in the 600 mg treatment group) and drowsiness (8.33% in the 600 mg treatment group), but these were not statistically significant from the placebo group. The incidence of AEs in the placebo group, 400 mg and 600 mg treatment groups was 70.83%, 66.67% and 66.67%, respectively, with no statistical difference between the three groups. The average incidence of significant adverse events in each of the placebo group and the 400 mg and 600 mg treatment groups was 54.17%, with no statistical difference between the three groups. The incidence of SAEs (including mortality and hospitalization) in each of the placebo group and the 400 mg and 600 mg treatment groups was 29.17%, 20.83% and 20.83%, with no statistical difference between the three groups.
After 12 months of treatment, pirfenidone was effective in slowing down the decline in DLco%, DLco, SaO2 and SpO2 immediately after 6MWT. No drug-related SAEs were observed and rash and nausea were the most common ADRs. The results show that pirfenidone has potentialPhase 3 clinical trials. Currently, nintedanib is approved for the treatment of IPF.anti-fibrosis in patients with SSc-ILD.
Phase 3 clinical trialPneumoconiosis
Pneumoconiosis refers to a spectrum of pulmonary diseases caused by inhalation of mineral dust, usually as the result of certain occupations. The main pathological features include chronic pulmonary inflammation and progressive pulmonary fibrosis, which can eventually lead to death caused by respiratory and/or heart failure. Pneumoconiosis is widespread globally and a serious global public health concern. Its high incidence and mortality result from improper occupational protection and the lack of early diagnostic methods and effective treatments.
According to Frost & Sullivan, in the PRC, the prevalence of pneumoconiosis increased from 850,299 patients in 2017 to 926,769 patients in 2022, and it is expected to increase to 962,562 patients by 2027 and 980,917 patients by 2031. The market size of anti-fibrosis drugs for pneumoconiosis is expected to reach $12.1 million by 2027 and $64.1 million by 2031 a CAGR of 51.7% from 2027 to 2031.
To date, there are two pirfenidone product candidates for the treatment of SSc-ILD
We are conducting a randomized, double-blind, placebo-controlled, multicenter Phase 3pneumoconiosis in various clinical trial. The purpose of this registration trial is to evaluate the efficacy and safety of pirfenidonestages in the treatment of SSc-ILD. The primary endpoint is the change in FVC% at 52 weeks of treatment compared to baseline. 144 patients are planned to be enrolled in the trial, with 108 in the treatment group and 36 in the control group.
This trialPRC. We enrolled the first patient in June 2018. Due to the outbreak of COVID-19 and the scarcity of eligible patients, this trial is still in the process of recruiting patients and therefore no clinical results are currently available for analysis.
our Phase 3 clinical trialstudy of pirfenidoneETUARY for the treatment of DM-ILD
We are conducting a randomized, double-blind, placebo-controlled, multicenter Phase 3 clinical trial. The purpose of this registration trial is to evaluatepneumoconiosis in June 2022, making ETUARY the efficacy and safety of pirfenidonemost clinically advanced anti-fibrosis drug for the treatment of DM-ILD. The primary endpoint is the change in FVC% at 52 weeks of treatment compared to baseline. 152 patients will be enrolledpneumoconiosis in the trial, with 114 in the treatment group and 38 in the control group.
This trial enrolled the first patient in June 2018. Due to the outbreakPRC. As of COVID-19 and the scarcity of eligible patients, this trial is still in the process of recruiting patients andMay 15, 2023, no clinical results are currently available for analysis.
Phase 3 clinical trial of pirfenidoneanti-fibrosis product for the treatment of pneumoconiosis
We are conducting a randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical trial. The purpose of this registration trial is to evaluate the efficacy and safety of pirfenidone had been approved in the treatmentPRC.
An experimental study on silica-induced lung fibrosis in rats demonstrated that pirfenidone can slow the transformation from epithelial to mesenchymal cells when administered for 14 days and 28 days. These treatments were associated with a significant down-regulation of pneumoconiosis. The primary endpointvimentine and up-regulation of E-cadherin, suggesting that pirfenidone can exhibit an inhibiting effect on silica-induced epithelial-mesenchymal transition (“EMT”) in rats.
DKD
DKD is the change in force vital capacity at 52 weeks of treatment compared to baseline. 272 patients will be enrolleda chronic kidney disease (“CKD”) caused by diabetes mellitus. DKD is clinically manifested as specific pathological structural and functional changes in the trial, with 136kidney of diabetes patients. In addition, DKD has become the primary cause of progression from CKD to the end-stage renal disease and one of the main diseases causing renal fibrosis. As one of the serious complications of diabetes, DKD in the PRC is characterized by high prevalence, low awareness rate, low treatment grouprate and 136low control rate.
According to Frost & Sullivan, the prevalence of DKD in the control group.
We obtained ethics committee approval as of JanuaryPRC increased from 45.4 million patients in 2017 to 53.2 million patients in 2022, and enrolledit is expected to increase to 61.5 million patients by 2031. The DKD market in the first patientPRC increased from $24.2 billion in June 2022.2017 to $37.2 billion in 2022 and it is predicted to expand to $51.5 billion by 2027 and $60.3 billion by 2031.
Phase 1 clinical trialThe standard of pirfenidonecare (“SOC”) for DKD has been blood glucose control, blood pressure control and blood liquid control. However, current therapeutic strategies are far from being completely effective because no available therapy successfully prevents DKD and many patients still progress to end-stage renal disease. The current available drugs for the treatment of DKD
We are conducting an open-label, parallel-controlled, single-center clinical trial. The purpose of this registration trial is to evaluate the safety include hypoglycemic drugs, antihypertensive drugs and PK of a single dose of pirfenidone capsules in patients with CKD stages G2 and G3a. 24 subjects were enrolled, consisting of 12 patients with renal insufficiency and 12 healthy volunteers.
The Phase 1 clinical trial was completed in March 2022. In this trial, pirfenidone was tolerated when used in patients with chronic kidney disease G2 and G3a, therelipid-lowering drugs. There is no significant changespecific anti-fibrosis drug approved for the treatment of DKD globally or in the main pharmacokinetic parameters compared with healthy controls,PRC.
Pirfenidone has demonstrated positive therapeutic effects on DKD due to its unique mechanism of action. Several growth factors or cytokines that are locally produced in the kidney appear to contribute to the extracellular matrix accumulation, inflammation and no dose adjustmentscarring in progressive DKD. The TGF-ß1 system is required.activated and plays a pathogenetic role in DKD in