Regulus HCV Candidate On Clinical Hold After Second Jaundice Report

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

More from Clinical Trials

In Brief: Gilead HIV Trials On Hold Over Safety Signal

 

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 

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

 

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 

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 

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 

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

 

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.