Denovo Biopharma LLC Announces FDA Approval of IND to Initiate First Biomarker-Guided Global CNS Clinical Trial for Treatment-Resistant Depression (TRD)

SAN DIEGO: SAN DIEGO, Jan. 31, 2022 /PRNewswire/ — Denovo Biopharma LLC ("Denovo"), a pioneer in applying precision medicine to the development of innovative therapies, today announced that the FDA has authorized the company’s investigational new drug (IND) application of DB104 (liafensine) for treatment-resistant depression (TRD) to proceed, which enables Denovo to start a global Phase 2b clinical trial to assess the safety and efficacy of liafensine in patients with TRD. This will be the third potentially pivotal global trial that Denovo is conducting, and more importantly, may be the first ever genetic biomarker-guided clinical trial conducted for central nervous system (CNS) diseases.
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