With Phase III Failure, Cytokinetics Shelves Tirasemtiv, Pivots To ALS Backup

Partnered with Astellas, the San Francisco-area biotech hopes next-generation CK-107 will succeed in a measure of slow vital capacity due to stronger potency and better tolerability compared to tirasemtiv.

nerve cells, concept for neurodegenerative and neurological disease

Cytokinetics Inc. thought it had the answer in mid-2016 when it decided to design a Phase III in amyotrophic lateral sclerosis (ALS) around a secondary endpoint it hit in Phase II with tirasemtiv, but it didn't. The company reported Phase III results showing the novel skeletal muscle activator did not hit the primary or any secondary endpoints in the VITALITY-ALS study and now it is shelving the compound.

The San Francisco-area biotech revealed the Phase III failure Nov. 21, but added that it is not giving up on its mechanism of action in ALS

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

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By 

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By 

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By 

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

More from R&D

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.

In Brief: Strong OS Results For Immutep’s Eftilagimod/Keytruda Combo In Head And Neck Cancer

 

Australian firm's combo of eftilagimod and Keytruda shows 17.6-month median overall survival in first-line HNSCC patients with low PD-L1, raising hopes for potential accelerated approval.

In Brief: Positive New Data For Aptose’s Triplet Therapy In 1L AML

 

Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.