Theravance Announces Positive Early Data On JAK Inhibitor
Zacks Investment Research | Sep 09, 2019 11:46PM ET
Theravance Biopharma, Inc. (NASDAQ:TBPH) announced promising outcomes in the areas of safety and tolerability, pharmacokinetics and preliminary pharmacodynamic activity from a phase I study on its investigational, inhaled, lung-selective pan-Janus kinase (JAK) inhibitor, TD-8236. The candidate is being developed for the treatment of inflammatory lung diseases with minimal systemic exposure.
The early-stage randomized, placebo-controlled study on TD-8236 consists of two parts. The first evaluated the candidate in single ascending doses (SAD) (up to 4500 mcg) in healthy patients while the second evaluated TD-8236 in multiple ascending doses (MAD) (up to 4000 mcg), which is administered as a once-daily dose to patients with mild asthma for seven consecutive days.
Initial data from the study showed that in both regimens, TD-8236 was well tolerated with no evidence of local irritation or bronchoconstriction in the given patient population. Also, none of the patients discontinued the treatment and there were no serious adverse side effects reported.
Importantly, the candidate produced the desired biological activity in the target patient population as it led to reduction in fractional exhaled nitric oxide (FeNO) in mild asthma patients who had elevated levels of FeNO. Treatment with TD-8236 also resulted in minimal systemic exposure.
Shares of Theravance were up almost 1.4% post this news on Monday. However, the stock has declined 14.6% so far this year against the Zacks Investment Research
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