Tuesday April 23, 8:05 am Eastern Time
Press Release
SOURCE: Inflazyme Pharmaceuticals Ltd.
Inflazyme LSAID Demonstrates Promising Results in Phase II Asthma Study; Inflazyme and Aventis to Advance Second Generation LSAID into Next Asthma Study
RICHMOND, BRITISH COLUMBIA and BRIDGEWATER, NEW JERSEY--Inflazyme Pharmaceuticals Ltd. (TSE: IZP - news) and Aventis Pharmaceuticals, the U.S. pharmaceutical company of Aventis Pharma AG (NYSE: AVE - news), today announced results from Inflazyme's Phase II pilot clinical trial of IPL576,092 (HMR4011A), its first LSAID (Leukocyte Suppressing Anti-inflammatory Drug) for the oral treatment of asthma.
This Phase II study was the first ever conducted with an LSAID in asthmatic patients. The endpoints chosen were standard for the evaluation of anti-asthma compounds: early and late phase bronchoconstriction (expressed as changes to FEV1) to an allergen challenge, in addition to airway hyper-reactivity (PC20 response to histamine) and percentage increase in eosinophils in induced sputum.
IPL576,092 showed a difference favorable to the compound at the primary endpoint, late-phase bronchoconstriction, but the improvement did not reach formal statistical significance (p equals 0.13). The greatest difference between active compound and placebo was found in the higher of two dose groups, suggesting a dose relationship with regard to the main endpoint.
With respect to secondary endpoints, IPL576,092 showed a statistically significant (p less than 0.05) improvement relative to placebo in airway hyper-reactivity to histamine provocation and a very strong trend (p equals 0.06) towards preventing the eosinophil increase in induced sputum after allergen challenge. IPL576,092 was well tolerated and not associated with any serious adverse events.
Due to the favorable results from this allergen challenge study, the companies are accelerating the development of the second generation LSAID, IPL512,602, as the new lead compound in their ongoing respiratory collaboration. This compound, already in Phase Ib (multiple dose) clinical studies, has been shown to have a more predictable pharmacokinetic profile and to be more potent in pre-clinical models of asthma in comparison to IPL576,092.
``We are pleased that these results demonstrate that LSAIDs can positively affect components of the asthmatic response in humans. This represents a strong basis for the continued development of LSAIDs in asthma,'' stated Ian McBeath, President & CEO of Inflazyme Pharmaceuticals Ltd. ``Importantly, the reduction in airway hyper-reactivity and sputum eosinophilia is consistent with the proposed mode of action for the LSAID class of compounds. While this study has been ongoing we have been developing further LSAIDs. Based on data obtained to date, we and our partner Aventis believe that the second generation LSAIDs offer advantages over IPL576,092, hence our decision to advance IPL512,602 as the new lead in asthma.'' |
