Some interesting initial results were achieved in Syntara's (SNT: $0.023) Phase II study in patients who are potentially to progress to Parkinson's disease.
The study was funded by the Parkinson's UK organization and conducted under Professor Simon Lewis at the Parkinson's Disease Research Clinic at Macquarie University and at the Oxford Parkinson's Disease Centre. Forty patients were recruited, including a placebo arm (10 participants) and an active arm (30 patients) who received a daily oral dose of Syntara's drug candidate SNT-4728 for three months.
The participants all had an unusual sleeping trait, termed isolated REM Sleep Behaviour Disorder (iRBD), whereby dreams are physically acted out during sleep. It is believed to be a precursor to Parkinson's disease. Other indicators of prodromal disease is a poor sense of smell and poor colour recognition.
The patient population appears to have been very well selected, with 95% having alpha-synuclein misfolds in the CSF. This ends up leading to toxic fibrils known as Lewy bodies and is central in the Parkinson's disease pathway.
This was the first study of its type, with patients remaining in the prodromal state for around 16 years on average before progression to neurodegenerative disease.
Syntara's drug candidate acts as an anti-inflammatory agent, having been previously investigated in other inflammatory-driven diseases, including the liver disease NASH.
Early Results
The results showed a statistically significant reduction in brain inflammation in just one side of the brain and in just the one region, called the putamen. The putamen is involved in motor control pathways in the brain. A reduction in neuroinflammation was seen in this region in 20 of the 30 patients in the active arm.
In Parkinson's the disease starts in one side of the brain. Of interest is whether an effect might be observed from 12 months of treatment in the other side of the brain, according to Professor Lewis.
There was no reduction observed in other pre-defined areas of interest in the brain. And there was no reduction in any areas of the brain in the placebo group.
Summary
Full results from the study are expected this quarter. From there a decision will be made on the next steps, which could involve a longer study. Syntara believes the strong safety profile supports longer term use of the investigational therapy.
Syntara is unlikely to fund further development of the program. However according to CEO Gary Phillips, there is strong curiosity about this program from potential partners and with 50 clinical centres awaiting the full results.
Bioshares recommendation: Speculative Buy Class A
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