- CEO: Dr. Pierre-Henri Benhamou
- Founded: 2002
- Headquarters: Bagneux, France
- https://www.dbv-technologies.com/en
- Co announced topline results from the PEPITES (Peanut EPIT Efficacy and Safety) Phase III trial evaluating the safety and efficacy of Viaskin Peanut in children four to 11 years of age. Topline results show a statistically significant response with a favorable tolerability profile, with 35.3% of patients responding to Viaskin Peanut 250 g after 12 months of treatment as compared to 13.6% of patients in the placebo arm. However, the primary endpoint, which evaluates the 95% confidence interval (CI) in the difference in response rates between the active and placebo arms, did not reach the 15% lower bound of the CI that was proposed in the study's Statistical Analysis Plan (SAP) submitted to the U.S Food and Drug Administration (FDA).
- Following initial conversations with the FDA on these topline efficacy and safety results, DBV will continue ongoing discussions with the agency, and plans to proceed with the BLA preparation process.
- Preliminary analysis of the Cumulative Reactive Dose (CRD) -- a key secondary endpoint measuring threshold reactivity during the double-blind, placebo-controlled food challenge (DBPCFC) -- showed that at month 12, patients treated with Viaskin Peanut 250 g and placebo reached a mean CRD of approximately 900 mg (median 444 mg) and 360 mg (median 144 mg) of peanut protein, respectively. Mean CRD at baseline was approximately 210 mg (median 144 mg) in both groups. This increase from baseline was statistically significant compared to placebo, and these findings are consistent with the data observed in the Company's Phase IIb study of Viaskin Peanut. For reference, one peanut contains approximately 250 mg peanut protein.
- The Company continues to anticipate announcing the topline results of the REALISE Phase III trial in November 2017.
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