Concert trial on hold while FDA reviews tox studies

Dive Brief:

  • Concert Pharmaceuticals informed investors Wednesday morning the Food and Drug Administration has put its mid-stage alopecia candidate on clinical hold.
  • The Phase 2a study of the JAK1/2 inhibitor CTP-543 had been initiated and enrolled, but dosing of patients had not yet begun.
  • Concert said the hold was not due to safety concerns, but claimed it was needed for the FDA to review non-clinical toxicology studies. The FDA has 30 days after Concert submits the data to notify the biotech if the hold is lifted 

Dive Insight:

Concert pharma investors weren't thrilled with the news of the clinical trial hold. The stock was down by nearly 10% Wednesday morning, trading at just under $15 per share. 

While the company emphasized the FDA had not cited a specific safety concern, it is unclear how long the trial will be delayed. 

Concert has been competing with Aclaris Therapeutics to bring a baldness treatment to market. Aclaris currently has its candidate, ATI-50001, set to begin a mid-stage trial later this year. ATI-50001 is an oral JAK 1/3 inhibitor. The company is also developing a topical version of the treatment for which it hopes to file an Investigational New Drug application in the second half of 2017. 

Earlier this year, Concert signed an agreement with Vertex Pharmaceuticals for its cystic fibrosis candidate, giving it a $160 million injection of cash to put toward the development of CTP-543. 

CTP-543 is a deuterated version of Incyte's blockbuster Jakafi (ruxolitinib). Incyte isn't developing the oral version of Jakafi for alopecia, but has a topical form in the works. Incyte has taken legal action against Concert for patent infringement related to the drug. 

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Filed Under: Clinical Trials Regulatory / Compliance
Top image credit: knerri61/pixabay