LEXINGTON, MA, USA I July 16, 2014 I Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that the FDA has provided notification that the Company has completed the necessary preclinical toxicology testing in order to administer repeated doses of CTP-354 in excess of 6 mg per day, lifting its partial clinical hold. As a result, the Company intends to initiate dosing of 12 mg per day of CTP-354 in the third quarter of this year as part of its ongoing multiple ascending dose Phase 1 trial.
About CTP-354
CTP-354 is a novel, potentially first-in-class, non-sedating, once-daily oral treatment for spasticity. Concert is initially developing CTP-354 for use in patients with spinal cord injury and in patients with multiple sclerosis to address significant unmet medical needs. CTP-354 is a subtype-selective GABAA receptor modulator. GABAA receptors are found in the nervous system and, when activated, reduce the transmission of certain nerve signals. Several classes of widely used drugs target GABAA receptors, including benzodiazepines, but do not have the receptor subtype selectively of CTP-354.
About Spasticity
Spasticity is a chronic condition characterized by involuntary tightness, stiffness or contraction of muscles that occurs in patients who have damage to the brain or spinal cord. Spasticity can result from a wide range of disorders, including multiple sclerosis, spinal cord injury, cerebral palsy, amyotrophic lateral sclerosis, stroke and hereditary spastic paraplegia. Symptoms can range from mild muscle tightness to more severe symptoms, including crippling and painful inability to move limbs that can result in disability and diminished quality of life. The American Association of Neurologic Surgeons estimated in 2006 that there were 12 million patients suffering from spasticity worldwide.
About Concert
Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel small molecule drugs. This approach starts with approved drugs, advanced clinical candidates or previously studied compounds that have the potential to be improved with deuterium substitution to enhance clinical safety, tolerability and efficacy. The company is developing a broad pipeline targeting CNS disorders, renal disease, inflammation and cancer.
SOURCE: Concert Pharmaceuticals
Post Views: 164
LEXINGTON, MA, USA I July 16, 2014 I Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that the FDA has provided notification that the Company has completed the necessary preclinical toxicology testing in order to administer repeated doses of CTP-354 in excess of 6 mg per day, lifting its partial clinical hold. As a result, the Company intends to initiate dosing of 12 mg per day of CTP-354 in the third quarter of this year as part of its ongoing multiple ascending dose Phase 1 trial.
About CTP-354
CTP-354 is a novel, potentially first-in-class, non-sedating, once-daily oral treatment for spasticity. Concert is initially developing CTP-354 for use in patients with spinal cord injury and in patients with multiple sclerosis to address significant unmet medical needs. CTP-354 is a subtype-selective GABAA receptor modulator. GABAA receptors are found in the nervous system and, when activated, reduce the transmission of certain nerve signals. Several classes of widely used drugs target GABAA receptors, including benzodiazepines, but do not have the receptor subtype selectively of CTP-354.
About Spasticity
Spasticity is a chronic condition characterized by involuntary tightness, stiffness or contraction of muscles that occurs in patients who have damage to the brain or spinal cord. Spasticity can result from a wide range of disorders, including multiple sclerosis, spinal cord injury, cerebral palsy, amyotrophic lateral sclerosis, stroke and hereditary spastic paraplegia. Symptoms can range from mild muscle tightness to more severe symptoms, including crippling and painful inability to move limbs that can result in disability and diminished quality of life. The American Association of Neurologic Surgeons estimated in 2006 that there were 12 million patients suffering from spasticity worldwide.
About Concert
Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel small molecule drugs. This approach starts with approved drugs, advanced clinical candidates or previously studied compounds that have the potential to be improved with deuterium substitution to enhance clinical safety, tolerability and efficacy. The company is developing a broad pipeline targeting CNS disorders, renal disease, inflammation and cancer.
SOURCE: Concert Pharmaceuticals
Post Views: 164
