BioRestorative Therapies (NASDAQ:BRTX) announced new preliminary 26–52 week blinded data from the first 10 patients with chronic lumbar disc disease (cLDD) enrolled in the ongoing Phase 2 clinical trial of BRTX-100.
BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is the company’s lead clinical candidate.
No serious adverse events were reported in any of the 10 safety run-in subjects. Notably, there was also no dose (40 million cells) limiting toxicity at 26-52 weeks.
In addition, BioRestorative reported blinded clinical data on the secondary efficacy endpoint of at least a 30% decrease in pain as 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) reported a >30% improvement in VAS versus baseline;
- At 52 weeks, 100% of subjects (n=4) reported a >30% improvement in VAS versus baseline (n=4);
- 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; and
- At 26 weeks, 70% of subjects (n=10) reported a >30% decrease in pain (VAS) and a >30% increase in function (ODI).
“Blinded preliminary clinical data of safety and efficacy endpoints from the ongoing Phase 2 clinical trial of BRTX-100 in the treatment of cLDD are very encouraging, with patient reported pain and function outcomes demonstrating a positive trend,” Lance Alstodt, BioRestorative’s CEO, said in a statement.
“Most importantly, at 26 weeks 70% of the patients are reporting a greater than 30% increase in function and a more than 30% decrease in pain. If data continues with this trend, we are confident that we will hit our efficacy end points for the Phase 2 trial.”
This new blinded preliminary safety and efficacy data from the ongoing Phase 2 clinical trial of BRTX-100 will be described in podium presentation later today at the Orthopaedic Research Society (ORS) Philadelphia Spine Research Society (PSRS) 7th International Spine Research Symposium, taking place in Skytop, Pennsylvania.
BioRestorative will also host a webcasted conference call with an associated slide presentation today at 4:30pm EST to review the BRTX-100 data, as well as review its third quarter 2024 financial results and provide a business update.
