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Intercept Increases Chance Of Success In NASH Without Significant Delay

 
• By Joseph Haas

Ocaliva could now qualify for accelerated approval in NASH by meeting either of two Phase III co-primary endpoints, whereas the trial initially was designed for success on both measures.

Liver

Intercept Pharmaceuticals Inc. is making a pair of protocol changes to the pivotal trial of its Ocaliva (obeticholic acid or OCA) in non-alcoholic steatohepatitis (NASH), but it maintains those will increase the odds of producing successful data, without pushing back the timelines in any material way.

Despite the protocol changes announced Feb. 10, Intercept said it should complete enrolling sufficient patients (about 750) by mid-2017 for...

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

 
• By Sushmita Panda

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.

Deal Build-Up Amid Early ‘Deep’ Response For IGI’s Trispecific In Myeloma

 
• By Anju Ghangurde

IGI CEO tells Scrip about the “very encouraging” feedback at ASCO to promising early data for the firm's first-in-class investigational trispecific antibody in multiple myeloma. Is a licensing deal in the offing?

Ascletis Plans China Submission After Positive Denifanstat Phase III Acne Results

 
• By Sushmita Panda

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 Joseph Haas

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.

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Europe’s Drugmakers Lament EU Pharma Package

 
• By Kevin Grogan

EFPIA says reforms make the continent less attractive for innovative firms.

ASCO: Carvykti Data Raise Possibility Of Myeloma Cure

 
• By Alaric DeArment

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

 
• By Jessica Merrill

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