Concert Pharmaceuticals, Inc. (CNCE - Free Report) announced that it has initiated a multiple-ascending dose (“MAD”) phase I study on its pipeline candidate, CTP-692 (a novel deuterium-modified form of D-serine), as an adjunctive treatment for schizophrenia.
The phase I program now includes three clinical studies, which will evaluate a single dose of CTP-692, multiple ascending dose of the candidate and compare the candidate with D-serine. Top-line data from the single-dose and MAD studies is expected in the second quarter of 2019.
Shares of the company have lost 17% so far this year against the industry’s rise of 15%.
The early-stage development program will evaluate the safety, tolerability and pharmacokinetics of CTP-692 in healthy volunteers. Data from the studies will support the progress of the candidate to advanced stages of development, which will evaluate the efficacy of CTP-652 as adjunct to standard antipsychotic medicines in improving positive and negative symptoms as well as cognitive function in schizophrenia patients.
The company believes that CTP-692 holds potential to offer a new approach of treating symptoms of schizophrenia. However, we note that development of candidates by multiple pharma companies related to brain disorders like Alzheimer’s and schizophrenia have faced setbacks in the past with several companies discontinuing development. Thus, development of CTP-692 may face a difficult path ahead.
Concert Pharmaceuticals is a small biotech developing candidates targeting multiple indications in 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 autoimmune disease, alopecia areata. The candidate enjoys Fast Track status in the United States. However, Concert Pharmaceuticals is fighting litigation with Incyte Corporation (INCY - Free Report) related to certain patents covering Incyte’s JAK inhibitor, Jakafi.
Concert Pharmaceuticals also has a few partnered pipeline candidates, which are being developed in collaboration with other pharma companies. The company is also developing AVP-786 in collaboration with privately-held Avanir Pharmaceuticals for treating agitation associated with Alzheimer’s disease; JZP-386 in collaboration with Jazz Pharmaceuticals PLC (JAZZ - Free Report) for narcolepsy and CTP-730 in collaboration with Celgene Corporation (CELG - Free Report) for inflammatory disease.
Concert Pharma currently carries a Zacks Rank #5 (Strong Sell).
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