Menlo Therapeutics Inc. (NASDAQ:MNLO) has announced positive data from its second phase clinical study evaluating the initial efficacy and safety of FCD105. FCD105 is topical minocycline (3% minocycline and 0.3% adapalene foam) for treating moderate to severe acne vulgaris.
Positive data for FX2016-40 study
FX2016-40 enrolled around 447 participants in the US that were randomized to FCD105, 3% minocycline, or 0.3% adapalene foam. Menlo has commenced preparing to carry out the end of the second phase FDA meeting by the end of 2020.
The study shows that FCD105 had some significant improvement relative to vehicle foam for Investigator’s Global Assessment endpoint and the absolute change in inflammatory counts from baseline to week 12. The study was originally designed to show the statistical change between FCD105 and 0.3%adapalene or 3% minocycline foams treatment. Nevertheless, some of the comparisons failed to show significant improvement at week 12 of FCD105. However, there was significant improvement shown for FCD105 on the efficacy endpoints for the comparison after 12 weeks.
Similarly, the study assessed the counts of absolute reduction in the non-inflammatory lesions after 12 weeks. Despite there being no numerical improvements, this was attributed to the outlier results that affected the FCD105 and vehicle foam treatment groups. On the other hand, an absolute reduction in counts of non-inflammatory lesions for FCD105 after 12 weeks demonstrated some improvements.
FCD105 didn’t have adverse effects
According to the results, the most common adverse effect from the treatment was respiratory infection with the common cutaneous adverse effect being dry skin. The treatment did not show severe adverse effects with those reported considered mild.
The company’s chief scientific officer, Dr. Iain Stuart, indicated they were delighted with the study results. He added that results indicate that there is the potential of FCD105 being the best in class therapy for acne patients, and it could be a new treatment alternative for the challenging condition. Stuart added that they will be engaging the FDA on plans of a third phase trial.