Phytopharm reports good headline results in Parkinson's disease studies
Phytopharm plc said it had positive headline results from the successful completion of two key studies.
The first is a non-clinical efficacy study of Cogane in the gold-standard, non-clinical model of Parkinson's disease (PD).
The second is a Phase Ib safety, tolerability and comparative pharmacokinetic clinical study in healthy volunteers and patients with mild-moderate PD.
Efficacy study
Oral administration of Cogane over 18 weeks significantly reduced parkinsonian disability by 43% in a non-human primates - a macaque model of PD (the gold standard for PD research), which will be clinically relevant if repeated in PD patients. Encouragingly, a statistically significant reduction in parkinsonian symptoms was reached after 9 weeks of administration with Cogane. The magnitude of the effect increased over the subsequent 9 weeks of administration and was still increasing at the end of the study in week 18. These data strongly support the continued development of Cogane as an exciting, new and potentially disease-modifying therapy for PD. This study was funded by a $1.16m grant from the Michael J. Fox Foundation (MJFF).for Parkinson's Research
Phase Ib safety, tolerability and pharmacokinetic clinical study
Cogane was shown to be safe and generally well tolerated in both healthy volunteers and PD patients over the 28 day study period. At steady state, plasma levels in PD patients taking Cogane at a dose of 150 mg/day reached levels associated with efficacy in the non-human primate study and other non-clinical disease models of PD.
The positive results from these two studies strongly support the company's position that Cogane is a highly encouraging novel potential treatment for PD. These results justify Phytopharm's stated strategy to move forward rapidly to a Phase II, proof-of-concept study for Cogane in patients with PD. The study is planned to start in Q2, 2010.
MJFF CEO Katie Hood said: "Ongoing development of therapies based around neurotrophic factors is critical in moving these proteins from promise to reality as a practical treatment for PD patients.
"MJFF remains optimistic about the continued development of an orally bioavailable product such as Cogane that might stimulate production of neurotrophic factors in the brain."
Phytopharm CEO Sandy Morrison said: "We intend to move rapidly to a proof-of-concept clinical study which will represent a key milestone. We would like to acknowledge the strong support from both the PD charities for the Cogane programme which made these results possible".
