DBV Technologies: VITESSE Phase 3 VIASKIN Peanut Patch nakamit ang pangunahing endpoint

Ang VITESSE Phase 3 trial ay nakamit ang pangunahing endpoint nito na may makabuluhang epekto sa paggamot (p<0.001) na nagpapakita ng 46.6% responders kumpara sa 14.8% placebo. Karagdagang data na ipinakita sa AAAAI 2026 ay nagpapakita ng pare-parehong desensitization sa iba't ibang baseline eliciting dose strata at nagpapatibay sa robustness ng pangunahing pagsusuri. Plano ng kumpanya na magsumite ng BLA sa FDA sa unang kalahati ng taong ito.

Mahahalagang fact

Na-file: Mar 2, 2026, 12:54 PM
Kaganapan: Topline na resulta
Direksyon: Positibo
Kumpanya: DBVTDBV Technologies
Asset: VIASKIN Peanut Patch
Pinagmulan: SEC 8-K
Kumpiyansa: May source
P-value: p<0.001
Mas mababang CI: 24.5%
Pagkakaiba: 31.8%
Pagpapatala: 654
Antas ng tugon: 46.6% kumpara sa 14.8%
Antas ng anaphylaxis: 0.5%
Antas ng paghinto: 3.2% kumpara sa 0.5%

Sipi mula sa source

EX-99.1 2 d110966dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 DBV Technologies Highlights Additional Data from Successful Phase 3 VITESSE Study at the AAAAI 2026 Annual Meeting • Approximately 83% of children treated with the VIASKIN ® Peanut Patch increased their eliciting dose at month 12, compared to approximately 48% in the placebo group • Approximately 60% of children treated with the VIASKIN ® Peanut Patch increased their eliciting dose by at least two doses at month 12, compared to 23% in the placebo group • 24% of children on placebo decreased their eliciting dose between the baseline and month 12 double-blind, placebo-controlled food challenge, compared to only 6.4% of children treated with the VIASKIN ® Peanut Patch DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasd

SEC 8-K