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Concert Pharma’s CTP-692 Positive for Schizophrenia in Phase I

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Concert Pharmaceuticals, Inc. CNCE announced positive results from two phase I studies on its pipeline candidate, CTP-692 (a novel deuterium-modified form of D-serine), which is being developed as an adjunctive treatment for schizophrenia. The single-dose and multiple-ascending-dose studies evaluated the safety, tolerability and pharmacokinetics of CTP-692 on healthy volunteers.

Data from both studies showed that CTP-692 was well-tolerated over the dose ranges tested for the given indication with no serious adverse events being reported. Notably, the analysis showed that key blood and urine markers of kidney function did not indicate any signs of renal impairment.

Concert Pharma plans to begin a phase II program on CTP-692 for patients with schizophrenia during the fourth quarter of 2019. Notably, CTP-692 was also well tolerated in the doses expected to be evaluated in the phase II study. The company plans to present data from these two studies at an upcoming scientific meeting.

Shares of Concert Pharma were up almost 2.6% following this development on Wednesday. However, the stock has declined 17.5% so far this year against the industry’s increase of 5.5%.


The phase I probe includes three clinical studies, which will evaluate a single dose of CTP-692, multiple ascending dose of the candidate and a crossover comparison of the candidate with D-serine. Results from the crossover study, initiated last December, showed that CTP-692 increased plasma exposure as compared to D-serine and was well tolerated with no serious hostile events being recorded.

Outcomes from the investigations will support the progress of the candidate to advanced stages of development, which will evaluate the efficacy of CTP-692 as an adjunct to standard antipsychotic medicines in improving positive and negative symptoms as well as cognitive functions in schizophrenia patients.

Concert Pharma is a small biotech, developing candidates targeting multiple indications like central nervous system disorders, autoimmune disease and inflammation.

The company’s lead proprietary pipeline candidate, CTP-543 (a JAK inhibitor), is being developed in a phase II study for treating the autoimmune disease — alopecia areata. The candidate enjoys a Fast Track status in the United States. Last week, the company announced completion in the phase II study, which will assess the once-daily dose of CTP-543 compared with the twice-daily oral dosing of CTP-543 in patients with alopecia areata. Top-line data from this dose-ranging analysis is expected in fourth-quarter 2019.

However, Concert Pharma is fighting litigation with Incyte Corp. INCY related to certain patents covering Incyte’s JAK inhibitor, Jakafi (ruxolitinib). CTP-543 is a deuterium-modified version of Jakafi.

Zacks Rank & Stocks to Consider

Concert Pharma currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Evotec AG EVTCY and AcelRx Pharmaceuticals, Inc. ACRX. While Evotec sports a Zacks Rank #1 (Strong Buy), AcelRx has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Evotec’s earnings estimates have been revised 14.4% upward for 2019 and 41.2% for 2020 over the past 60 days. The stock has rallied 27.3% year to date.

AcelRx’s loss per share estimates have been narrowed 4.5% for 2019 and 1.5% for 2020 over the past 60 days. The stock has inched up 2.2% so far this year.

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