BioRestorative Therapies Inc. (NASDAQ:BRTX) revealed on Wednesday new preliminary 26 to 52 week blinded data from the first 10 patients with chronic lumbar disc disease (cLDD) enrolled in the ongoing Phase 2 trial of BRTX-100.
BRTX-100 is a novel cell-based therapeutic engineered to target body areas with little blood flow.
A Phase 2 study is evaluating the safety and efficacy of BRTX-100 in treating cLDD. Up to 99 eligible subjects will be enrolled.
The 10 safety run-in subjects reported no serious adverse events (SAEs).
There was also no dose (40X106 cells) limiting toxicity at 26 to 52 weeks.
The company reported blinded clinical data on the secondary efficacy endpoint of at least a 30% decrease in pain measured on the Visual Analog Scale (VAS) and at least a 30% increase in function based on the Oswestry Disability Index (ODI) at week 52.
The blinded preliminary efficacy endpoint data demonstrated:
- At 26 weeks, 70% of subjects (n=10) and 100% of subjects (n=4) at 52 weeks reported a >30% improvement in VAS versus baseline.
- At 12 and 26 weeks, 70% of subjects (n=10) had a >30% improvement in ODI versus baseline.
- At 52 weeks, 100% of subjects (n=4) had a >30% improvement in ODI versus baseline.
- At 26 weeks, 70% of subjects (n=10) reported a >30% decrease in pain (VAS) and a >30% increase in function (ODI).
BRTX Price Action: BRTX stock is down 1.22% at $1.62 at last check Wednesday.
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