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

Inclisiran’s Safety Data Suggest Game-Changing Potential In PCSK9 Market

 
• By Joseph Haas

The Medicines Co. unveiled Phase III safety data for inclisiran showing safety and tolerability comparable to placebo and efficacy in line with the PCSK9 inhibitor class – which should be the reassurance it needs for the oral agent. 

Uninstalling Cholesterol
Inclisiran could offer patients twice-annual dosing

The Medicines Co. followed up its 26 August top-line readout for the Phase III ORION-11 trial of inclisiran with a full dataset that shows the short-interfering RNA (siRNA) therapy can offer LDL cholesterol-lowering capability similar to on-market PCSK9 inhibitors with twice-yearly dosing and a safety and tolerability profile similar to placebo.

Presenting the data at the European Society of Cardiology meeting on 2 September, The Medicines Co. asserted that inclisiran can be a market-disrupting LDL-C therapy that will address needs for...

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

Summit’s Ivonescimab Shows Significance On PFS, But Not Overall Survival

 
• By Joseph Haas

In a study intended to show similar benefit in western patients, PD-1/VEGF-targeting ivonescimab met a progression-free survival endpoint, but missed on OS.

Sanofi Bid For Second COPD Approval Hurt By Mixed Itepekimab Data

 
• By Kevin Grogan

One Phase III trial hits but a second study misses by a mile.

In Brief: Neurocrine Details New Data For Schizophrenia Drug Moving To Phase III

 
• By Sushmita Panda

Neurocrine reports new details of positive Phase II results in schizophrenia and a favorable safety and cardiovascular profile for its first-in-class oral M4 agonist, now moving to Phase III trials.

Merck & Co./Daiichi Pull Patritumab Deruxtecan BLA On Disappointing OS

 
• By Jessica Merrill

Patritumab deruxtecan is the lead antibody drug conjugate in a $22bn deal signed between the two partners, with the decision marking a disappointing setback

More from R&D

Senti’s Computer-Logic Inspired Cell Therapy Shows Early Promise

 
• By Andrew McConaghie

The biotech believes its logic-gated cell therapies can get round the need for ‘clean targets’ which limit CAR-Ts and ADCs.

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 
• By Sushmita Panda

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.

GSK’s Bet On Spero’s Oral cUTI Antibiotic Poised To Pay Off With New Phase III Data

 
• By Joseph Haas

Spero and partner GSK have Phase III non-inferiority data to support approval of tebipenem as the first oral antibiotic for complicated urinary tract infections.