BioRestorative Therapies’ BRTX-100 Shows Promise in Chronic Lumbar Disc Disease Trial
BioRestorative Therapies Inc. (BRTX) announced positive preliminary data from its ongoing Phase 2 clinical trial evaluating the safety and efficacy of BRTX-100, a novel cell-based therapeutic, for the treatment of chronic lumbar disc disease (cLDD).
The trial, which is enrolling up to 99 eligible subjects, has already enrolled 10 patients in the safety run-in phase. Importantly, these initial patients reported no serious adverse events (SAEs) and no dose-limiting toxicity at both 26 and 52 weeks.
The company also released blinded data on the secondary efficacy endpoint of pain reduction and functional improvement. The results are encouraging:
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Pain Reduction:
At 26 weeks, 70% of the enrolled subjects experienced a greater than 30% decrease in pain as measured by the Visual Analog Scale (VAS). This improvement increased to 100% at 52 weeks.*
Functional Improvement:
At both 12 and 26 weeks, 70% of the subjects demonstrated a greater than 30% improvement in function as measured by the Oswestry Disability Index (ODI). At 52 weeks, this improvement reached 100%.These results highlight the potential of BRTX-100 as a treatment option for cLDD. The therapy’s ability to target areas with limited blood flow could make it a valuable treatment for patients suffering from this debilitating condition.
What is BRTX-100?
BRTX-100 is a novel cell-based therapeutic engineered to target body areas with limited blood flow. It is designed to deliver therapeutic cells directly to the affected area, potentially promoting healing and reducing pain.
Looking Ahead
These preliminary results are encouraging, but it’s important to note that the trial is still ongoing. Further data from the remaining subjects will be crucial in confirming these initial findings. However, the safety profile and preliminary efficacy data suggest that BRTX-100 has the potential to become a significant treatment option for chronic lumbar disc disease.
