Biolex Therapeutics announced results demonstrating reduced rates of depression from its SELECT-2 Phase 2b trial of Locteron for hepatitis C treatment at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL).
SELECT-2 patients treated within the expected commercial dose range of Locteron experienced substantially lower rates of depression than patients treated with the PEG-Intron control. Locteron, the only controlled-release interferon alpha, is designed to offer tolerability and dosing advantages and serve as a core component of new combination therapies as the treatment of hepatitis C evolves to triple- and quad-drug regimens.
In a survey of hepatitis C patients published in the Journal of Viral Hepatitis, depression was cited as the number one adverse event impacting patient adherence to treatment, and studies show patients who develop depression during treatment have a reduced chance of achieving a cure. SELECT-2 results show the majority of depression episodes occur by the 12th week of treatment and potentially shorter durations of treatment are unlikely to eliminate the problem of depression.
In SELECT-2, three different doses of Locteron were studied (320, 480, and 640 µg). The doses demonstrated viral kinetics and sustained virologic response (SVR) rates that were comparable with or exceeded the PEG-Intron control while also achieving a statistically significant reduction in flu-like adverse events and lower use of concomitant medications.
The commercial dose of Locteron is expected to be in the 320 to 480 µg range, as the SVR rates for these two doses were comparable with or exceeded the control, and the tolerability advantages (including lower discontinuation rates due to adverse events) were greatest within this dose range.
In SELECT-2, depression was assessed by two methods: patient self-reporting using a validated instrument, and adverse event assessments performed by medical personnel at the clinical sites during weekly visits by patients. The SELECT-2 results demonstrated patients experienced depression early in the study, with 75% of cases occurring within the first 12 weeks of the trial under each of the reporting methodologies. Depression was less frequent for the Locteron doses encompassing the expected commercial dose range compared to the PEG-Intron control.
Throughout the 48 weeks of treatment, patients reported their status using the Beck Depression Inventory (BDI), an instrument for measuring the severity of depression. Mean BDI scores peaked by week 12 of treatment for all Locteron doses and for the PEG-Intron control group. The increase in peak mean BDI scores was substantially less for all three Locteron doses compared to the PEG-Intron group. Results demonstrated fewer patients reported scores greater than 16 using the BDI (the threshold for mild depression) in the 320 and 480 µg Locteron dose groups compared to the PEG-Intron group.
Release Date: March 31, 2011