BioRestorative Therapies (NASDAQ:BRTX) announced the public availability of a poster, presented yesterday at the Orthopaedic Research Society’s 2024 Annual Meeting, which describes preliminary 26 and 52 week blinded data from the ongoing Phase 2 clinical trial of the company’s lead clinical candidate, BRTX-100, in subjects with chronic lumbar disc disease (cLDD).
Previous clinical studies have demonstrated that the harsh microenvironment of the disc could impact cell dose viability and result in a non-efficacious or the worsening of clinical outcomes. Although this is blinded and early clinical data, BioRestorative said it is important to note that the Visual Analog Scale, Oswestry Disability Index, Roland Morris Disability Questionnaire, and Functional Rating Index collected at weeks 26 and 52 post-injection demonstrated a positive trend compared to baseline. In addition to safety outcomes, changes to these pain and function scales compared to baseline are used by FDA to determine whether the trial will be allowed to proceed and ultimately gain BLA approval.
“We are thrilled with the progress of our ongoing clinical development programs. With regard to the Phase 2 study investigating the use of BRTX-100 in the treatment of cLDD, we are strongly encouraged by the preliminary data presented at ORS 2024. The preliminary clinical data shows meaningful signals in patients enrolled in the study and, importantly, no notable safety signals,” Lance Alstodt, BioRestorative’s CEO, said in a statement.
The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study. A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or placebo.