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Posted On: 05/03/2022 11:00:01 AM
Post# of 148899
Nice to see enthusiasm picking up about NASH. Seems like we have not had much to get excited about lately. Since the older PRs were deleted from CYDY's website, I went on wayback and found the PR from 1/5/22 about NASH. Thought folks would enjoy seeing this again. Here are the highlights.
Leronlimab 14-Week, NASH Clinical Trial Met Primary Endpoint (PDFF) and Secondary Endpoint (cT1) for Per Protocol Population in 350 mg Weekly Dose
Primary endpoint (PDFF) was achieved in both Intention to Treat and Per Protocol Populations
VANCOUVER, Wash.--(BUSINESS WIRE)-- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"
, a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced positive results from the 350 mg weekly dose of its Phase 2 NASH clinical trial. The trial was conducted in two parts. Part 1 compared a 700 mg weekly dose and placebo in a double-blind randomized manner and Part 2 evaluated a 350 mg weekly dose as an open label study compared to the same placebo blinded arm. Results of the topline report will be announced when available.
The primary endpoint, PDFF (proton density fat fraction), is an MRI-derived biomarker for fatty deposition, while the secondary endpoint, cT1, is an iron-corrected T1 mapping representative of liver inflammation and fibrosis. These two values are used to evaluate the risk of NASH. CytoDyn’s Phase 2 clinical trial compared the changes from baselines in these endpoints. The leronlimab 350 mg dose versus placebo comparison for the primary endpoint PDFF was statistically significant. Leronlimab compared to placebo also reached near significance for the secondary endpoint cT1. There were no significant differences in treatment emergent adverse events between leronlimab and placebo groups.
Christopher P. Recknor, M.D., CytoDyn’s Senior Executive Vice President of Clinical Operations, stated, “We thank our sites, vendors and staff who helped make this trial possible. We are in the process of analyzing biomarker data including CCR5 haplotype information to better understand responder rates and mechanism of action. Given 5% of the world population is estimated to have NASH with 20% progressing to cirrhosis, this signal gives hope for a therapeutic intervention for this disease.”
About Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic steatohepatitis (NASH) is a chronic liver disease characterized histologically by the presence of hepatic inflammation and cell injury (hepatocellular ballooning) due to hepatic fat accumulation (steatosis) equal or superior to 5 percent of hepatocytes. Unhealthy eating habits and lack of physical activity in the absence of excessive alcohol consumption contributes to the development of NASH. NASH can progress to high‐burden conditions such as cirrhosis, end-stage liver disease, and hepatocellular carcinoma (HCC). Despite its very high burden, there are currently no approved pharmacological therapies for NASH. Available therapies focus solely on treating NASH comorbidities, such as obesity, type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD), while NASH management options focus on lifestyle changes, based on diet and exercise, and control of the associated comorbidities. Lifestyle changes have demonstrated the greatest benefit in improving steatosis and mild fibrosis; however, as patients with advanced fibrosis due to NASH are at a significantly higher risk of liver‐related mortality, pharmacological treatments are urgently needed.
Leronlimab 14-Week, NASH Clinical Trial Met Primary Endpoint (PDFF) and Secondary Endpoint (cT1) for Per Protocol Population in 350 mg Weekly Dose
Primary endpoint (PDFF) was achieved in both Intention to Treat and Per Protocol Populations
VANCOUVER, Wash.--(BUSINESS WIRE)-- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"
, a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced positive results from the 350 mg weekly dose of its Phase 2 NASH clinical trial. The trial was conducted in two parts. Part 1 compared a 700 mg weekly dose and placebo in a double-blind randomized manner and Part 2 evaluated a 350 mg weekly dose as an open label study compared to the same placebo blinded arm. Results of the topline report will be announced when available. The primary endpoint, PDFF (proton density fat fraction), is an MRI-derived biomarker for fatty deposition, while the secondary endpoint, cT1, is an iron-corrected T1 mapping representative of liver inflammation and fibrosis. These two values are used to evaluate the risk of NASH. CytoDyn’s Phase 2 clinical trial compared the changes from baselines in these endpoints. The leronlimab 350 mg dose versus placebo comparison for the primary endpoint PDFF was statistically significant. Leronlimab compared to placebo also reached near significance for the secondary endpoint cT1. There were no significant differences in treatment emergent adverse events between leronlimab and placebo groups.
Christopher P. Recknor, M.D., CytoDyn’s Senior Executive Vice President of Clinical Operations, stated, “We thank our sites, vendors and staff who helped make this trial possible. We are in the process of analyzing biomarker data including CCR5 haplotype information to better understand responder rates and mechanism of action. Given 5% of the world population is estimated to have NASH with 20% progressing to cirrhosis, this signal gives hope for a therapeutic intervention for this disease.”
About Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic steatohepatitis (NASH) is a chronic liver disease characterized histologically by the presence of hepatic inflammation and cell injury (hepatocellular ballooning) due to hepatic fat accumulation (steatosis) equal or superior to 5 percent of hepatocytes. Unhealthy eating habits and lack of physical activity in the absence of excessive alcohol consumption contributes to the development of NASH. NASH can progress to high‐burden conditions such as cirrhosis, end-stage liver disease, and hepatocellular carcinoma (HCC). Despite its very high burden, there are currently no approved pharmacological therapies for NASH. Available therapies focus solely on treating NASH comorbidities, such as obesity, type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD), while NASH management options focus on lifestyle changes, based on diet and exercise, and control of the associated comorbidities. Lifestyle changes have demonstrated the greatest benefit in improving steatosis and mild fibrosis; however, as patients with advanced fibrosis due to NASH are at a significantly higher risk of liver‐related mortality, pharmacological treatments are urgently needed.
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