BioRestorative’s BRTX-100 trial to use sham injection control, says Roth MKM

Roth MKM tells investors in a research note that the FDA, in accepting BioRestorative Therapies’ request for a protocol amendment in its ongoing trial evaluating BRTX-100 in chronic lumber disc disease, will allow future control group patients to receive a sham injection rather than a saline injection, which is important because the implementation of a sham injection will remove the possibility of saline injections leading to pain reduction in the control group and increase the trial’s likelihood of success. The firm, which made no change to its Buy rating or $15 price target, still expects enrollment to complete by YE24, as previously guided by management, and thinks the protocol amendment will have a meaningfully positive impact on the trial because the overwhelming majority of the 99 patients remain to be enrolled and treated.