Concert Pharmaceuticals says FDA lifts partial clinical hold for CTP-354 Concert Pharmaceuticals 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. 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.
Concert Pharmaceuticals achieves $2M milestone from Avanir Concert Pharmaceuticals (CNCE) announced that it has achieved a $2M milestone under its development and license agreement with Avanir Pharmaceuticals (AVNR) for the progression of the clinical development of AVP-786. The milestone is a result of Avanir initiating dosing of patients in a Phase 3 clinical trial with AVP-786 for the treatment of agitation in patients with Alzheimer's disease. The collaboration agreement between Concert and Avanir provides Avanir with worldwide rights to develop and commercialize AVP-786 and other deuterium-modified dextromethorphan (d-DM) compounds. Under the agreement, Concert is eligible to receive additional milestone payments based upon achievement of certain predefined regulatory and commercial targets. Avanir will continue to have overall responsibility for research, development and commercialization of d-DM compounds, including AVP-786, and Concert is eligible to receive tiered royalties on worldwide sales of any products containing d-DM. The milestone announced today is the third development milestone Concert has earned under this agreement.