NASH Phase 2 Trial Open-Label Portion Demonstrates
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Posted On: 12/13/2021 8:02:03 AM
NASH Phase 2 Trial Open-Label Portion Demonstrates Average 80 msec cT1 Reduction in 50% of Patients and Reduction of Nearly 50 msec in 80% of Patients
Average cT1 Reduction of 31.2 msec Over 14 Weeks for all 20 Patients
More than 80% of patients (5 out of 6) with severe NASH (cT1>1000 msec) had an average cT1 drop of 108 msec (-48 to -238 msec) and an average of about 20% fatty deposit reduction
11 of 20 patients (55%) had a decrease in cT1 and PDFF of about 75 msec and 16%, respectively
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 today additional preliminary results to date from the 20 patients who have completed the open-label portion of the Phase 2 trial for NASH (Nonalcoholic steatohepatitis).
Nonalcoholic fatty liver disease (NAFLD) has become the most common cause of chronic liver disease in adults worldwide. NAFLD patients could also develop NASH (Non-Alcoholic SteatoHepatitis) due to problems with liver fibrosis (the thickening and scarring of liver tissue). There are currently no U.S. Food and Drug Administration (FDA) approved treatments for NASH, and it was expected to be the number one cause of liver transplants in 2020.1 About 30 to 40 percent of adults in the U.S. are living with NAFLD, and 3 to 12 percent of adults in the U.S. are living with NASH.2
As previously reported, the Company’s pre-clinical study demonstrated strong positive data, highlighting the potential of leronlimab in treating nonalcoholic fatty liver disease (NAFLD), a common precursor to NASH. Inhibition of CCR5 has been shown to reduce fibrosis in animal models of NASH liver fibrosis, and current data suggests the same trend in humans. PDFF (proton density fat fraction) is an MRI-derived biomarker for fatty deposition, while 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 current Phase 2 NASH trial is designed to test in 90 patients whether leronlimab may inhibit the devastating liver fibrosis associated with NASH. This trial consists of two parts. Part 1 is a double-blind placebo-controlled trial using 700 mg leronlimab vs. placebo in a 1:1 ratio. Part 2 is open-label, with all subjects receiving 350 mg leronlimab for 14 weeks. The primary and secondary endpoints are 14-week changes from baseline in PDFF and cT1, respectively.
Christopher P. Recknor, M.D., CytoDyn’s Senior Executive Vice President of Clinical Operations, stated, “The cT1 and PDFF changes we are seeing in patients who have completed the open-label portion are showing that leronlimab is reducing markers of NASH. These results will guide us in developing our phase 3 NASH trial.”
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, concluded, “We believe we have a very strong case to make for Breakthrough Therapy designation (BTD) for leronlimab treatment in NASH patients. We are eager to see the results of the blinded portion in the next couple of weeks. Upon unblinding, if the results are supportive, we intend to file for BTD and to seek accelerated approval for use of leronlimab in NASH and NAFLD patients in the U.S. and abroad. We will also aggressively seek partnerships, especially with big pharmaceuticals who have experienced recent failures in their NASH trials.”
Average cT1 Reduction of 31.2 msec Over 14 Weeks for all 20 Patients
More than 80% of patients (5 out of 6) with severe NASH (cT1>1000 msec) had an average cT1 drop of 108 msec (-48 to -238 msec) and an average of about 20% fatty deposit reduction
11 of 20 patients (55%) had a decrease in cT1 and PDFF of about 75 msec and 16%, respectively
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 today additional preliminary results to date from the 20 patients who have completed the open-label portion of the Phase 2 trial for NASH (Nonalcoholic steatohepatitis). Nonalcoholic fatty liver disease (NAFLD) has become the most common cause of chronic liver disease in adults worldwide. NAFLD patients could also develop NASH (Non-Alcoholic SteatoHepatitis) due to problems with liver fibrosis (the thickening and scarring of liver tissue). There are currently no U.S. Food and Drug Administration (FDA) approved treatments for NASH, and it was expected to be the number one cause of liver transplants in 2020.1 About 30 to 40 percent of adults in the U.S. are living with NAFLD, and 3 to 12 percent of adults in the U.S. are living with NASH.2
As previously reported, the Company’s pre-clinical study demonstrated strong positive data, highlighting the potential of leronlimab in treating nonalcoholic fatty liver disease (NAFLD), a common precursor to NASH. Inhibition of CCR5 has been shown to reduce fibrosis in animal models of NASH liver fibrosis, and current data suggests the same trend in humans. PDFF (proton density fat fraction) is an MRI-derived biomarker for fatty deposition, while 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 current Phase 2 NASH trial is designed to test in 90 patients whether leronlimab may inhibit the devastating liver fibrosis associated with NASH. This trial consists of two parts. Part 1 is a double-blind placebo-controlled trial using 700 mg leronlimab vs. placebo in a 1:1 ratio. Part 2 is open-label, with all subjects receiving 350 mg leronlimab for 14 weeks. The primary and secondary endpoints are 14-week changes from baseline in PDFF and cT1, respectively.
Christopher P. Recknor, M.D., CytoDyn’s Senior Executive Vice President of Clinical Operations, stated, “The cT1 and PDFF changes we are seeing in patients who have completed the open-label portion are showing that leronlimab is reducing markers of NASH. These results will guide us in developing our phase 3 NASH trial.”
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, concluded, “We believe we have a very strong case to make for Breakthrough Therapy designation (BTD) for leronlimab treatment in NASH patients. We are eager to see the results of the blinded portion in the next couple of weeks. Upon unblinding, if the results are supportive, we intend to file for BTD and to seek accelerated approval for use of leronlimab in NASH and NAFLD patients in the U.S. and abroad. We will also aggressively seek partnerships, especially with big pharmaceuticals who have experienced recent failures in their NASH trials.”
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