MedPath

BioRestorative Therapies' BRTX-100 Shows Positive Phase 2 Data for Chronic Lumbar Disc Disease

• BioRestorative Therapies reports positive preliminary data from its Phase 2 trial of BRTX-100 for chronic lumbar disc disease (cLDD). • The trial, involving 10 patients, showed no serious adverse events and no dose-limiting toxicity at 26-52 weeks. • At 52 weeks, 100% of subjects (n=4) reported a >30% improvement in pain (VAS) and function (ODI) versus baseline. • BRTX-100, a cell-based therapy, targets areas with limited blood flow and is being evaluated in a randomized, double-blinded, controlled study.

BioRestorative Therapies, Inc. has announced promising preliminary data from its ongoing Phase 2 clinical trial of BRTX-100 for the treatment of chronic lumbar disc disease (cLDD). The data, which covers the first 10 patients enrolled in the trial over a 26-52 week period, indicates both safety and potential efficacy of the novel cell-based therapy. The results will be presented at the Orthopaedic Research Society (ORS) Philadelphia Spine Research Society (PSRS) 7th International Spine Research Symposium.

Phase 2 Trial Design and Patient Outcomes

The Phase 2 trial is a prospective, randomized, double-blinded, and controlled study designed to evaluate the safety and efficacy of BRTX-100 in treating cLDD. The trial aims to enroll up to 99 eligible subjects across 16 clinical sites in the United States, with participants randomized in a 2:1 ratio to receive either BRTX-100 or a placebo. The preliminary data reported is from an initial safety run-in with 10 subjects.

Safety Profile

According to the company, no serious adverse events (SAEs) were reported in any of the 10 safety run-in subjects. Furthermore, there was no dose (40X10 cells) limiting toxicity observed at 26-52 weeks, suggesting a favorable safety profile for BRTX-100 at the tested dose.

Efficacy Endpoints

In addition to safety, the trial assessed the secondary efficacy endpoint of at least a 30% decrease in pain, as measured by 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 the following:
  • 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.
  • 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).

About BRTX-100

BRTX-100 is a novel cell-based therapeutic engineered to target areas of the body with limited blood flow. It represents BioRestorative Therapies' lead clinical candidate and is designed to address the underlying causes of chronic lumbar disc disease by promoting tissue repair and regeneration.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

VRON-0200 Shows Promise in Phase 1b Trial for Chronic Hepatitis B Functional Cure

Virion Therapeutics' Phase 1b trial of VRON-0200 has completed enrollment for the first two cohorts, involving 27 chronic hepatitis B patients on antiviral therapy.
VRON-0200, a T cell-based immunotherapy, demonstrated safety, tolerability, and anti-HBV activity in early data, even in patients with impaired HBV immunity.

Bitterroot Bio's BRB-002 Shows Promise in Phase 1 Trial for Atherosclerosis

Bitterroot Bio announced positive Phase 1 results for BRB-002, an immune-modulating protein therapy targeting CD47, in healthy volunteers.
The study demonstrated that BRB-002 was safe and well-tolerated across all tested doses, with no serious adverse events reported.

Immix Biopharma's NXC-201 CAR-T Shows Promise in Relapsed/Refractory AL Amyloidosis

Immix Biopharma's NXC-201 demonstrates a 75% complete response rate in relapsed/refractory AL Amyloidosis patients, offering hope where no FDA-approved drugs exist.
The NEXICART-1 Phase 1/2 study highlights a 31.5-month best response duration, with the response ongoing, showcasing the potential long-term benefits of NXC-201.

Bionomics' BNC210 Shows Positive Phase 2 Results in PTSD Patients, Phase 3 Planned

Bionomics' BNC210 demonstrated statistically significant improvement in PTSD symptom severity compared to placebo at Week 12, with benefits observed as early as Week 4.
The Phase 2 ATTUNE study also revealed clinically meaningful improvements in depressive symptoms and sleep quality among patients treated with BNC210.

Barinthus Bio's VTP-300 Shows Promise in Phase IIb Trial for Chronic Hepatitis B

Barinthus Bio's Phase IIb HBV003 trial shows that VTP-300, combined with low-dose nivolumab, leads to HBsAg loss in chronic hepatitis B patients.
Eight patients experienced complete HBsAg loss, with two achieving functional cure, defined as sustained HBsAg loss and undetectable HBV DNA off-treatment for six months.

EnteroBiotix Completes Phase 2 Trial Recruitment of EBX-102-02 for Irritable Bowel Syndrome

EnteroBiotix has completed recruitment for its Phase 2 TrIuMPH trial, which is evaluating EBX-102-02 in 122 patients with moderate to severe irritable bowel syndrome (IBS).
The trial includes patients with both constipation-predominant IBS (IBS-C) and diarrhea-predominant IBS (IBS-D), with 62 and 60 participants respectively.

Arbutus Biopharma's Imdusiran Shows Promise in Hepatitis B Functional Cure

Arbutus Biopharma's IM-PROVE I Phase 2a trial reveals potential advancements in chronic hepatitis B (cHBV) treatment using imdusiran.
The trial achieved a 25% functional cure rate overall, with 50% in HBeAg-negative patients with low baseline HBsAg levels.

Hope Biosciences' Stem Cell Therapy Shows Promise in Phase II MS Trial

Hope Biosciences' HB-adMSCs demonstrated statistically significant improvements in physical and mental health for relapsing-remitting MS patients compared to placebo.
The Phase II trial (NCT05116540) involved six intravenous infusions of 200 million stem cells over 32 weeks, totaling 1.2 billion cells per patient.

Benitec Biopharma's BB-301 Gene Therapy Shows Swallowing Improvement in OPMD Patients

Benitec Biopharma's BB-301 gene therapy demonstrated clinically meaningful improvements in swallowing for OPMD patients in a Phase 1b/2a trial.
The first patient showed a 35% reduction in the Sydney Swallow Questionnaire (SSQ) score after 270 days of treatment.

Spine BioPharma Completes Enrollment in Phase 3 Trial of SB-01 for Chronic Low Back Pain

Spine BioPharma completed enrollment in its Phase 3 MODEL trial, evaluating SB-01 for chronic low back pain (CLBP) due to degenerative disc disease (DDD).
The trial enrolled 417 subjects across 30 sites in the U.S. to assess the safety and efficacy of SB-01 in adults with CLBP and related functional impairments.

Reference News

[1]
BioRestorative Therapies, Inc. Reports Positive Preliminary Phase 2 BRTX-100 Clinical Data
marketscreener.com · Nov 13, 2024

BioRestorative Therapies, Inc. reports preliminary 26-52 week blinded data from Phase 2 trial of BRTX-100 for chronic lu...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy