1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Regulus HCV Candidate On Clinical Hold After Second Jaundice Report

 
• By Joseph Haas

First jaundice adverse event was deemed unlikely to be connected to treatment with RG-101, and the second patient presents similar profile of overall health and co-morbidities.

Although the issue seems unlikely to be related to the study drug, Regulus Therapeutics Inc.'s mid-stage hepatitis C candidate RG-101 has been placed on clinical hold by FDA after a second patient presented a serious adverse event of jaundice.

It's a potentially serious setback for the clinical-stage microRNA specialist, which is trying to elbow into the competitive HCV space...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

In Brief: Gilead HIV Trials On Hold Over Safety Signal

 
• By Sushmita Panda

The FDA has paused Gilead’s HIV trials of GS-1720 and GS-4182 over safety concerns. The company’s upcoming PrEP PDUFA looks to be unaffected.

Spain’s SpliceBio Secures Sanofi and Roche Support In $135m Financing

 
• By Kevin Grogan

Series B cash will be used to advance its Stargardt disease gene therapy.

In Brief: PolyPid’s D-PLEX100 Aces Phase III Trial, US Partner, Submission Eyed

 
• By Sushmita Panda

PolyPid's D-PLEX100 meets Phase III endpoints this time around, significantly reducing surgical point infections in abdominal colorectal surgery, and is set for a US approval submission early next year.

Insmed’s PAH Data Indicate Potential To Surpass Established Therapies

 
• By Joseph Haas

Insmed’s inhaled treprostinil exceeded goals for reducing pulmonary vascular resistance and improving six-minute walk test distance in Phase IIb data.

More from R&D

Insmed’s PAH Data Indicate Potential To Surpass Established Therapies

 
• By Joseph Haas

Insmed’s inhaled treprostinil exceeded goals for reducing pulmonary vascular resistance and improving six-minute walk test distance in Phase IIb data.

NewAmsterdam’s CETP Inhibitor Improves Alzheimer’s Biomarkers

 
• By Mandy Jackson

Data from the BROADWAY trial testing LDL-C reduction in adults with ASCVD showed that obicetrapib improved Alzheimer’s disease biomarkers, including tau and amyloid. Analysts think the data could differentiate obicetrapib against competitors in the cholesterol market.

With ACIP Upheaval, Merck & Co. Among Those Left In A Lurch

 
• By Jessica Merrill and Bridget Silverman

Merck’s newly approved Enflonsia for RSV is one of the products that was expected to be recommended for use by the CDC advisory committee in June.