Foresee Pharmaceuticals (6576.TWO), (“Foresee”) announced today the primary endpoint data of FP-025, an oral MMP-12 inhibitor, in an allergic asthma Phase 2a proof-of-concept (POC) trial, in a press conference at Taipei Exchange.
Foresee has conducted the Phase 2a POC clinical trial in the Netherlands for its novel MMP-12 inhibitor, FP-025, for the treatment of allergic asthma. A total of 29 subjects were enrolled which has yielded 19 evaluable subjects. This was a randomized, double-blind, placebo-controlled, 2-way crossover trial design; non-smoking subjects with clinically stable, mild allergic asthma with blood eosinophilia were enrolled. There were two identical study periods of 12 treatment days each, separated by a washout period of at least 3 weeks (and no more than 7 weeks). The subjects were treated with either FP-025 (400 mg BID) or matching placebo in a randomized cross-over fashion.
The primary endpoint was to determine the effect of FP-025 versus placebo on allergen-induced late asthmatic response (LAR), defined as FEV1 (Forced Expiratory Volume in 1 second) AUC3-8h (Area Under Curve from 3 to 8 hours post allergen challenge).
During this clinical trial, incoming data from experimental HDM-sensitized mice showed long-lasting anti-inflammatory efficacy as well as disease-modifying effects. In view of these findings and given first-in-class intervention in asthma patients using a cross-over design, the presence of a possible treatment carry-over effect has been assessed. Indeed, at the treatment sequence of FP-025 followed by placebo, even though there was a washout period of 3 to 7 weeks between the two study periods, a statistically significant carry-over effect of FP-025 was found between the two sequences (P-value = 0.0340), suggesting that FP-025’s effect may persist into treatment period 2 when subjects were receiving placebo.
“Our data showed a positive finding of FP-025 in this trial. The results from 2 of the 3 methods have demonstrated statistically improvement of FP-025 over placebo in sequence and per mixed effects model ANOVA. The third method analyzed placebo and FP-025 in period 1; while not reaching statistical significance, a positive trend of FP-025 over placebo has shown. Currently, we are conducting analyses on additional secondary endpoints including biomarker studies which hopefully will enlighten the underlying mechanism of FP-025. The work is expected to be completed in the next 1 to 2 months.” said Dr. Yisheng Lee, Chief Medical Officer of Foresee.
“Given first-in-class intervention and a cross-over design, the initial sample size (32 evaluable) comprised twice as many subjects than usually needed in such allergen challenge studies using LAR(AUC3-8h) as primary endpoint, i.e. 8-10subjects. In line with this design, our 19 evaluable subjects represent an adequate number. In addition, the wash-out period was initially also considered long enough for both the subsequent allergen challenge as well as FP-025, since in general a carry- over effect is rare for small molecules, such as FP-025. The finding of a carry over effect is considered positive considered how short the treatment was given.” said Dr. Zuzana Diamant, pulmonologist and Dr. Rene Lutter, Amsterdam UMC, University of Amsterdam, both are the principal investigators of this trial.
“The primary endpoint data looks promising. This is another important advancement milestone for Foresee. The subsequent licensing discussion will be initiated as planned.” said Dr. Ben Chien, Chairman and CEO of Foresee.
