Concert’s Early-Stage Cystic Fibrosis Drug Shows Promise

Concert Pharmaceuticals, Inc. CNCE announced new results from Part 1 of a multiple ascending dose phase I study on CTP-656 comparing the candidate to Vertex Pharmaceuticals Incorporated’s VRTX Kalydeco (ivacaftor) for the treatment of patients with cystic fibrosis.

The company is looking to evaluate CTP-656 both as a monotherapy and in combination with other CFTR modulators for the treatment of patients with cystic fibrosis.

Results from the study confirmed that CTP-656 has a superior pharmacokinetic profile to Kalydeco. This included a longer half-life of approximately 15 hours, a reduction in the rate of clearance and a substantial increase in exposure and greater plasma levels at 24 hours.

We note that a previously reported phase I single ascending dose study on CTP-656 had also proved the favorable pharmacokinetic properties of CTP-656 with an aqueous suspension.

In Part 2 of the multiple ascending dose phase I study, the company intends to assess three doses of CTP-656 (ranging from 75 mg to 225 mg) compared to placebo. Top-line data from this portion of the study should be out in the second quarter of 2016.

Meanwhile, Concert plans to use the single-dose tablet formulation of CTP-656 in a multiple ascending dose phase II study.

We are encouraged by the company’s progress with CTP-656. As per the Cystic Fibrosis Foundation, about 70,000 people have cystic fibrosis around the world.

We expect investor focus to remain on updates pertaining to CTP-656’s development.

Concert holds a Zacks Rank #2 (Buy). A couple of favorably ranked stocks in the health care sector include Corcept Therapeutics Incorporated CORT and Trillium Therapeutics Inc. TRIL, both carrying a Zacks Rank #1 (Strong Buy).

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