Arrowhead Research Corp (NASDAQ:ARWR) a biopharmaceutical firm advancing targeted RNAi therapeutics, demonstrated results from a Phase 2a clinical trial at The AASLD Liver Meeting 2015®. The report stated that its lead drug ARC-520 against chronic HBV effectively lowered HBV viral antigens resulting from cccDNA.
HBsAg was reduced considerably with a maximum decline of 1.9 logs and a mean maximum decline of 1.5 logs in treatment naïve HBeAg-positive patients. Arrowhead stated that this direct antiviral impact was even recorded 57 days after a single dosage. These results strongly support progress of ARC-520, and company has initiated numerous studies targeted at producing a functional treatment of HBV.
The expert speaks
Christopher Anzalone, Ph.D., the Chief Executive Officer and President of Arrowhead Research Corp (NASDAQ:ARWR), said that at AASLD they presented findings from company’s clinical plan and from a nonclinical trial in chimpanzees. Both of these trials demonstrated that ARC-520 can result in durable and deep reduction of HBV viral antigens.
This report provides the team additional confidence in the clinical program as they move forward with combination and multiple-dose trials of ARC-520 that the company expect will direct to host immune reconstitution, and functional cure.
The presentation
Man-Fung Yuen, M.D., Ph.D., a principal investigator of Phase IIa clinical trial, presented a late-breaking poster demonstration. It stated that ARC-520 produces durable and deep reduction of DNA and viral antigens in a phase 2 trial in patients suffering with chronic hepatitis B. Dr. Yuen showed that in the Heparc-2001 clinical trial, ARC-520 with entecavirrecorded maximum knockdown of HBeAg, HBsAg, HBV DNA, and HBcrAg of 1.7 logs, 1.9 logs, 4.3 logs, and 1.2 logs, respectively.
ARC-520 had a direct antiviral impact after a single dosing that was even noticed after 57 days. Consistent with results from Arrowhead’s chimpanzee trial, also showed at AASLD, disparities in viral antigen reduction implied that patients’ previously cured experimental drug probably had lower levels of cccDNA resulting mRNA transcripts.