Cytokinetics announced that results from three double-blind, randomized, placebo-controlled Phase I studies of CK-2127107 in healthy volunteers were presented in a poster at the 19th International SMA (Spinal Muscular Atrophy) Researcher Meeting held during the 2015 Annual SMA Conference at the Westin Crown Center in Kansas City, MO. In a pharmacodynamic study that was designed to assess the translation of the mechanism of CK-2127107 to humans, treatment with the fast skeletal muscle activator increased muscle force produced by the tibialis anterior muscle in response to nerve stimulation. Cytokinetics is developing CK-2127107 in collaboration with Astellas Pharma Inc.
"We are encouraged by the findings from our Phase I clinical studies program of CK-2127107 and the potential of CK-2127107 to improve skeletal muscle function,” said Fady I. Malik, M.D., Ph.D., Cytokinetics' Senior Vice President, Research and Development. “Based on these results, we look forward to initiating a Phase II trial in patients with SMA later this year in collaboration with our partner, Astellas.”
The poster titled, “Pharmacokinetics and Pharmacodynamics of the Selective Fast Skeletal Muscle Troponin Activator, CK-2127107,” was presented by Andrew Wolff, MD, FACC, Cytokinetics’ Chief Medical Officer, and included data from Phase I studies that evaluated the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic effects of CK-2127107 in healthy volunteers. In these studies, CK-2127107 was well-tolerated at single doses up to 4000 mg and the PK profile of CK-2127107 was linear and dose-proportional across the range of doses studied. Data from the Phase I studies also showed significant dose-, concentration-, and frequency-dependent increases in the force of muscle contraction elicited by nerve stimulation in healthy volunteers. The increases in force were most evident in the mid-range of nerve stimulation frequency, consistent with preclinical studies. By directly increasing skeletal muscle function, CK-2127107 may enhance physical performance in patients with neuromuscular diseases including SMA. These data support further evaluation of CK-2127107 and its potential to effect measures of muscle performance and function.
"We are encouraged by the findings from our Phase I clinical studies program of CK-2127107 and the potential of CK-2127107 to improve skeletal muscle function,” said Fady I. Malik, M.D., Ph.D., Cytokinetics' Senior Vice President, Research and Development. “Based on these results, we look forward to initiating a Phase II trial in patients with SMA later this year in collaboration with our partner, Astellas.”
The poster titled, “Pharmacokinetics and Pharmacodynamics of the Selective Fast Skeletal Muscle Troponin Activator, CK-2127107,” was presented by Andrew Wolff, MD, FACC, Cytokinetics’ Chief Medical Officer, and included data from Phase I studies that evaluated the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic effects of CK-2127107 in healthy volunteers. In these studies, CK-2127107 was well-tolerated at single doses up to 4000 mg and the PK profile of CK-2127107 was linear and dose-proportional across the range of doses studied. Data from the Phase I studies also showed significant dose-, concentration-, and frequency-dependent increases in the force of muscle contraction elicited by nerve stimulation in healthy volunteers. The increases in force were most evident in the mid-range of nerve stimulation frequency, consistent with preclinical studies. By directly increasing skeletal muscle function, CK-2127107 may enhance physical performance in patients with neuromuscular diseases including SMA. These data support further evaluation of CK-2127107 and its potential to effect measures of muscle performance and function.
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