NEWTON, Mass.--(BUSINESS WIRE)--Clinical Data, Inc. (NASDAQ: CLDA) today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for pulmonary arterial hypertension (PAH) to PRX-8066, the Company’s selective serotonin 2B (5-HT2B) receptor antagonist. The expression of 5-HT2B receptors is elevated selectively in the pulmonary vasculature of PAH patients, and these receptors mediate abnormal cell growth and proliferation.1 Analyses of results from a Phase II study of PRX-8066 in pulmonary hypertension associated with chronic obstructive pulmonary disease (COPD) demonstrated its capacity to reduce elevated pulmonary pressures. Based on these results and findings from animal models, the Company is developing plans for the continued clinical development of PRX-8066 for patients with PAH.
