Dicerna Prescription drugs has shared interim part 1 information on its Roche-partnered hepatitis B drug RG6346. The trial linked RG6346 to reductions in hepatitis B floor antigen (HBsAg) that recommend the RNAi remedy can maintain its personal in opposition to rival candidates in growth at Johnson & Johnson and Vir Biotechnology.
Roche paid $200 million upfront for a world license to RG6346 in October, giving it a spot in a race that J&J entered in 2018 by handing Arrowhead $250 million. Dicerna landed the Roche deal earlier than publishing scientific information on the remedy, making at present’s replace the primary vital likelihood to judge how the asset stacks up in opposition to the competitors.
After 122 days, sufferers who obtained the three or 6 mg/kg dose had skilled a imply discount in HBsAg of round 1.eight log10 IU/mL. That compares to reductions of 1.6 and a pair of.zero log10 IU/mL within the Vir and J&J research, respectively.
Dicerna additionally has early proof of the sturdiness of its remedy. The reductions seen at 112 days have been maintained throughout subsequent analyses, with some assessment-to-assessment variation. Dicerna has probably the most comply with up on a affected person within the 1.5 mg/kg cohort, who had a 2.2 log10 IU/mL discount at day 392.
Some sufferers skilled transient flares within the liver enzyme alanine aminotransferase after taking RG6346. Nevertheless, general liver artificial and excretory features had been preserved, and no topics discontinued on security grounds or skilled dose-limiting toxicities.
The information come from a small variety of topics—Dicerna enrolled 27 hepatitis B sufferers throughout two cohorts—however have supplied encouragement to Roche, which needs to develop a finite-duration drug that drives lasting reductions in circulating viral DNA.
“We’re very inspired by these early outcomes,” John Younger, international head of infectious ailments at Roche pRED, mentioned in a press release. “The extent and sturdiness of HBsAg discount seen on this trial is of nice curiosity, and we sit up for additional evaluating the potential of RG6346 in an HBV therapeutic treatment routine.” Roche is accountable for taking the drug into part 2.
The outcomes present early validation of Dicerna’s strategy to hepatitis B. With two conserved areas of the virus to goal at, Dicerna went with a drug that solely targets the S area. Dicerna selected to go away the X area alone after its preclinical analysis confirmed hitting each conserved areas of the virus led to shallower, shorter responses.
Dicerna shared the RG6346 information alongside an replace on an ongoing open-label extension research that’s assessing the protection and efficacy of nedosiran in main hyperoxaluria sufferers. Virtually 30% of topics enrolled within the trial had regular urinary oxalate ranges at three consecutive visits.