Trevi Therapeutics(US:TRVI)2021-05-14 13:33Financial Data and Key Metrics Changes - For Q1 2021, the company reported a net loss of $8.4 million, slightly improved from a net loss of $8.5 million in Q1 2020 [19] - R&D expenses decreased to $5.6 million from $6 million in the same period of 2020, primarily due to reduced clinical trial supply purchases [20] - G&A expenses were $2.5 million, down from $2.6 million in Q1 2020, mainly due to a decrease in stock-based compensation [21] - As of March 31, 2021, cash and cash equivalents totaled $41.6 million, down from $45 million at the end of 2020, expected to fund operations into Q2 2022 [21] Business Line Data and Key Metrics Changes - The company is conducting a Phase 2b/3 trial for pruritus in prurigo nodularis (PN), with over 60 sites activated and approximately 255 of the planned 360 subjects randomized, representing over 70% enrollment [8][9] - The Phase 2 trial for chronic cough in idiopathic pulmonary fibrosis (IPF) is facing challenges due to COVID-19 restrictions, but sites are beginning to reopen and screening is resuming [15][17] Market Data and Key Metrics Changes - The global prevalence of PN is estimated at 730,000 patients, with 300,000 in the U.S. and 430,000 in the rest of the world [7] - Approximately 130,000 patients in the U.S. and an equal number in Europe suffer from IPF, with over 1 million patients worldwide [13][14] Company Strategy and Development Direction - The company aims to complete enrollment for the PRISM trial in the second half of 2021, adjusting guidance due to potential summer slowdowns [11][19] - The company received Fast Track designation from the FDA for the PN indication, facilitating expedited development and review [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about enrollment momentum in the PRISM trial despite potential summer slowdowns, with ongoing engagement from study staff and investigators [42][45] - The company is focusing efforts on the UK for the IPF trial, pivoting away from Germany due to estimated timelines and costs [18][54] Other Important Information - The company is the only non-biologic oral candidate in late-phase development for PN, which may provide a competitive advantage [7] - Management highlighted the importance of understanding the variability in itch populations and the challenges in recruiting a homogeneous patient population for the PN study [32][34] Q&A Session Summary Question: Inquiry about the opioid approach and itch population variability - Management discussed the safety and efficacy of their oral formulation, emphasizing its well-characterized profile and dose response in different populations [26][28] Question: Update on enrollment pace and strategies to accelerate it - Management acknowledged a slight slowdown in enrollment but expressed confidence in the engagement of study sites and ongoing recruitment initiatives [42][45] Question: Progress on IPF trial and site reopening - Management confirmed that about a third of the sites are engaged in screening, with plans to add more sites in the UK as needed [53][54] Question: Updates on patients rolling over into the extension study and insights from recent studies - Management reported over 95% of patients rolling over into the extension study, with discontinuation rates in line with expectations [59][61]