6:09AM Sucampo Pharma announced earlier positive top-line results in Phase 1a trials of cobiprostone and SPI-3608 (SCMP) 6.16 : Co announced the positive top-line results of two recently completed clinical trials, a Phase 1a trial of cobiprostone and a Phase 1a trial of SPI-3608. The studies tested the tolerability and pharmacokinetic profiles versus placebo of the two compounds, both of which were demonstrated to be generally well-tolerated in the tested populations. In total, six doses of cobiprostone were tested. No serious or severe adverse events (AEs) were reported and the most frequently observed AE was mild diarrhea. Co also announced the positive top-line results of SPI-3608 in a Phase 1a single-oral-dose study that demonstrated the drug to be generally well tolerated in healthy volunteers. SPI-3608 is being investigated for the treatment of mild to moderate lumbar spinal stenosis (LSS) and may be investigated for additional indications in the future. The next phase of development for SPI-3608 is expected to begin in the first quarter of 2014.
"Pre-clinical data indicate that cobiprostone induces mucosal barrier repair and prevents mucosal barrier damage, and the fact that it was well-tolerated in this study is extremely encouraging. Even though we have not yet evaluated efficacy in patients, we are looking forward to advancing cobiprostone into Phase 1b later this year... Pre-clinical data on SPI-3608 indicate that the compound is capable of the treatment of spinal stenosis by increasing spinal cord blood flow."
