Denovo Biopharma LLC today announced that positive results for its biomarker-‑guided Phase 2b clinical trial (ENLIGHTEN) designed to assess the efficacy and safety of DB104 (liafensine) in patients with treatment-resistant depression (TRD) will be presented at two sessions at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami, FL.
| SAN DIEGO, May 28, 2024 /PRNewswire/ --Denovo Biopharma LLC (Denovo), a pioneer in applying precision medicine to the development of innovative drugs, today announced that positive results for its biomarker-‑guided Phase 2b clinical trial (ENLIGHTEN) designed to assess the efficacy and safety of DB104 (liafensine) in patients with treatment-resistant depression (TRD) will be presented at two sessions at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami, FL (https://ascpp.org/ascp-meetings/ascp-annual-meeting/):
“We are pleased to present detailed positive data from our ENLIGHTEN late-stage trial in TRD for the first time.” Matthew A. Spear, MD, Chief Medical Officer of Denovo Biopharma said, “We are pleased to present detailed positive data from our ENLIGHTEN late-stage trial in TRD for the first time. The trial met its primary and secondary endpoints and demonstrated the utility of Denovo’s unique genetic biomarker discovery platform. DGM4 guided enrollment of patients, thus indicating where liafensine may provide physicians and patients badly-needed therapies for TRD, which has a high unmet need. Additionally, to my knowledge this is the first time that a genetic biomarker has been used to identify and select the right patients for treatment in a psychiatric disease. This could enable easy identification of the appropriate treatment for patients via a simple blood draw or buccal swab in a clinical practice.” About the ENLIGHTEN Phase 2b Clinical Study The ENLIGHTEN study, a DGM4 biomarker-‑guided, randomized, double ‑blind, placebo ‑controlled global Phase 2b trial designed to validate the biomarker hypothesis, enrolled 197 patients with TRD. DGM4‑positive TRD patients who received liafensine demonstrated highly significant improvements over the 6 ‑week treatment period compared to those who received placebo. The primary endpoint was met: the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline for liafensine demonstrated a 4.4‑point improvement over placebo (p = 0.0056). All secondary endpoints were also met: changes in both the Clinical Global Impressions Scale‑Severity (CGI‑S) and the Sheehan Disability Scale (SDS) change from baseline for liafensine showed an approximately 36% improvement over placebo; additionally, the Clinical Global Impressions Scale-Improvement (CGI‑I) was 2.3 for liafensine, a 0.6‑point improvement over placebo (p = 0.0026). Liafensine was well tolerated and demonstrated an excellent safety profile consistent with previous clinical trials which included more than 2,200 subjects. For more information on ENLIGHTEN, visit https://clinicaltrials.gov/ct2/show/NCT05113771. About Treatment-Resistant Depression (TRD) More than 23 million people in the U.S. alone suffer from major depressive disorder (MDD). Over 30% do not benefit from currently available antidepressants and are diagnosed with TRD. TRD remains a highly unmet medical need indication as there are few approved pharmacological agents for TRD and overall, outcomes remain poor. About DB104 (liafensine) About Denovo Biopharma Contact
SOURCE Denovo Biopharma LLC |
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