Syntara (SNT: $0.019) has a three disease programs it is working on with three different compounds. One that would not be considered its core focus is SNT-4728, a compound that was previously licensed and returned, with a new potential application in early Parkinson's disease, or more specifically iRBD (isolated REM Sleep Behaviour Disorder).
About 70% of people with iRBD go on to develop Parkinson's disease and other related diseases.
Syntara has completed a 41 patient, placebo-controlled Phase II study in patients with iRBD. The subjects were treated for 12 weeks, and have been followed for an additional 12 weeks from completion of treatment.
After 12 weeks, there was some activity shown in one measure, that being a statistically significant (p=0.0145) reduction in neuroinflammation in one side of the brain in the treatment group. Parkinson's disease begins in one side of the brain.
Of interest now is that after 24 weeks, a positive outcome has been observed in motor function using part III of the measure MDS-UPDRS. Part III relates to motor function as observed by the clinical. (Part I relates to changes in non-motor function, Part II relates to changes observed by the patient, and Part IV measures complications to medications.)
In the placebo arm, the MDS-UPDRS Part III measure declined at 12 weeks with further decline at week 24, in line with historical expectations. In the subjects receiving SNT-4728, a small improvement was measured at 12 weeks but not statistically significant, but continued to improve in the 12 weeks following treatment (p=0.021).
The Principal Investigator of the study, Professor Simon Lewis, stated that "This study provides convergent exploratory evidence that SNT-4728 has biological activity in people with iRDB."
The question for Syntara is who will fund the next study, which may involve patients with early stage Parkinson's disease.
Key Program - Amsulostat to Begin Phase IIb Study
Syntara has detailed a Phase IIb study it intends to conduct with its lead drug candidate, Amsulostat, for the treatment of Myelofibrosis. This study is expected to begin in the current quarter, and is expected to cost between US$20 - US$25 million.
The study will seek to recruit 105 patients, and will be assessing the effect of adding amsulostat to two different JAK inhibitors used for the disease, ruxolitinib or momelotinib. In the first group of 75, two thirds will be in the active arm of amsulostat plus ruxolotinib, and one third receiving just ruxolitinib (with placebo). The second group of 30 patients will be similarly split but with the drug momelotinib.
The study will be seeking to recruit patients who are not responding well to the JAK inhibitor treatments. The study is expected to take 18 months to recruit, with patients to be treatmed for nine months.
The primary endpoint will be the proportion of patients achieving a TTS50 (total symptom score reduction of at least 50%). In a previous, smaller study with no control arm, of the 11 evaluable patients at week 24 or later, eight (73%) have achieved a TTS50. One of the key secondary endpoints will be changes in spleen size.
Summary
Syntara is capitalized at $37 million with a proforma cash balance of $18 million at the end of June. The company will obviously need additional funds (or a partner) to complete the Myelofibrosis study, and to proceed with an early Parkinson's disease study with SNT-4728.
Bioshares recommendation: Speculative Buy Class A
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