What Else Analysts Want To Know About Phase III Data For TMC’s Inclisiran

Looking to be a game-changer with a highly effective LDL-C-lowering agent dosed twice annually, The Medicines Company says inclisiran met efficacy endpoints in a large Phase III study. But observers await fuller data, including safety details.

LDL (Bad) Cholesterol level chart on a table. - Image
TMC hopes inclisiran can reduce LDL-C levels with twice-annual dosing

Top among the things analysts want to see when additional data for The Medicines Co.’s inclisiran are presented next week are the magnitude of the efficacy results for the RNA-interference therapy and a clear understanding of the safety profile, especially liver toxicity.

The Medicines Co. released topline Phase III results from the ORION-11 study, the first in a three-trial program, on 26...

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

Ascletis Plans China Submission After Positive Denifanstat Phase III Acne Results

 

Once-daily oral FASN inhibitor denifanstat meets all endpoints in a Chinese Phase III trial for moderate-to-severe acne, paving the way for a regulatory submission in China.

New Regenxbio DMD Data Support Gene Therapy Accelerated Approval

 
• By 

Regenxbio reported functional and biomarker data from an ongoing study of RGX-202, which it hopes to file for approval in Duchenne muscular dystrophy in 2026.

ASCO: Kite’s Dual-Targeting CAR-Ts Could Mitigate Toxicity, Resistance

 

Gilead’s Kite division presented Phase I data for its next-generation CAR-T therapy KITE-363 in patients with B-cell lymphomas.

Lyra Eyes US Filing For LYR-210 After Surprise ENLIGHTEN 2 Win

 

In a turn of fortunes, Lyra Therapeutics has reported positive Phase III results for LYR-210 in chronic rhinosinusitis, boosting hopes for US approval. The company plans to submit an NDA and pursue further trials, but its cash position is precarious.

More from R&D

ASCO: Carvykti Data Raise Possibility Of Myeloma Cure

 

J&J presented data at the American Society of Clinical Oncology meeting showing more than five-year disease- and therapy-free survival, but a myeloma working group will need to define what makes a cure.

Vigil’s Iluzanebart Disappoints In Rare Neurodegenerative Disease

 

The Phase II TREM2 agonist is not part of Sanofi’s planned acquisition.

Merus Raises $300m After ASCO Success

 

The company is raising the money to fuel development of its head and neck cancer candidate, petosemtamab, on the back of promising early data. Some analysts are stopping short of declaring it the winner against a rival product from Bicara, however.