NeuroBo Pharmaceuticals announced it received written communication from the U.S. Food and Drug Administration (FDA) that the clinical development program for Gemcabene, a peroxisome proliferation-activated receptor (PPARα) agonist, under development as a once-daily, oral therapy for the treatment of dyslipidemia, remains on partial clinical hold. In January 2016, the Gemcabene Phase 2 clinical study was placed on partial clinical hold as the FDA requested 2-year rat and mouse carcinogenicity studies to be completed and submitted.
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In May 2018, the company submitted the requested data to the FDA, which the Agency determined was insufficient to lift the partial clinical hold at that time. On April 20, 2020, the company filed an amendment to the FDA's partial clinical hold letter received in June 2018.
"While we are disappointed that the partial clinical hold was not lifted at this time, we plan to request additional clarification regarding the resolution options the FDA suggest in their response letter, in order to better evaluate a path forward for Gemcabene as a treatment for dyslipidemia," said Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo.