Slide 1: Results of a first-in-human trial of LIB-01
Results of a first-in-human trial of LIB-01. A novel, first in class potential oral ED drug with unique pharmacodynamic properties Harin Padma-Nathan Independent consultant Ray C. Rosen UCSF School of Medicine Christopher P. Forest Dominican University of California Mats Holmberg ANOVA,Karolinska Un
Slide 2: Disclosures
Disclosures • Harin Padma-Nathan, MD, FRCS • Consultant, Dicot Pharma • Founder, Vella Bioscience Inc. & Otrera Medical Inc.
Slide 3: LIB-01: A novel and first-in-class small molecule for ED
LIB-01: A novel and first-in-class small molecule (phragmalin-type limonoid) for ED Phase 1 Design • Safety following single (SAD, N=40) and multiple ascending dosing (MAD, N=24) • ED participants in MAD part of trial (age18-65 and IIEF-EF score 11-25 for inclusion) • 3-day dosing; 25mg QD, 25mg BID
Slide 4: Results
Results • Improved erectile function by IIEF-EF domain score – mean change 7.8 (83% normalized) • Increased erectile rigidity by RigiScan® • At least 28 days duration of pro erectile effect • Safety – mild, self-limited GI symptoms on day one Rigiscan IIEF-EF mean score Baseline Day 10 30,0 * 25,0 2
Slide 5: Conclusions LIB 01, phase 1 trial
Conclusions LIB 01, phase 1 trial ▪ Safe and well tolerated ▪ Improved erectile function demonstrated by IIEF-EF and RigiScan® ▪ Duration of pro erectile effect of at least 28 days following a 3-day dosing ▪ This new molecule has the potential to dramatically change the paradigm of ED management A P