CRx-170 is a novel synergistic combination drug candidate containing low dose budesonide and low dose nortriptyline.
As measured by forced expiratory volume (FEV1), the standard clinical measure of breathing capacity in asthma and chronic obstructive pulmonary disease (COPD), CRx-170 demonstrated a statistically significant improvement from treatment baseline.
The compound also demonstrated activity on immuno-modulatory markers, and was generally well tolerated with no serious adverse events reported.
In the study, one week of dosing with CRx-170 demonstrated a statistically significant mean percentage improvement in FEV1 from the treatment baseline of the study of approximately 6%.
Neither low dose nortriptyline as a single agent nor low dose budesonide as a single agent showed significant improvement in FEV1 from the separate study baseline used to evaluate the single agents.
In the wheal and flare skin test, otherwise known as the late allergen response (LAR), CRx-170 decreased the area of LAR by more than 50%.
“The observed effect of CRx-170 in such a short period of dosing, as measured by FEV1, the most clinically relevant endpoint and generally accepted measure of clinical activity, suggests that CRx-170 may have potential as a novel agent for the treatment of pulmonary diseases such as asthma and COPD,” said Dr Jan Lessem, chief medical officer of CombinatoRx. “Given these signals of clinical activity and observed immunological activity, CRx-170 certainly merits further clinical studies.”