BioRestorative Therapies Shares Rise 17% After FDA Clears Phase 2 Study Protocol Amendment

Dow Jones04-16

By Chris Wack

BioRestorative Therapies shares were up 17% to $1.55 after the company said that the U.S. Food and Drug Administration had cleared an important amendment to the protocol of the continuing Phase 2 study investigating the use of BRTX-100.

BRTX-100 is the company's lead cell therapy candidate for treating chronic lumbar disc disease.

The clinical-stage company said Tuesday the protocol amendment removes saline injection in the control arm of the study and replaces it with a sham injection. Control patients in the Phase 2 clinical trial will now have a needle placed in close proximity to the target disc, but the disc will not be pierced, nor will it have saline injected into it.

The safety and efficacy of BRTX-100 in treating chronic lumbar disc disease 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 U.S. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or a placebo.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

April 16, 2024 10:46 ET (14:46 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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