(AOF) – DBV Technologies has announced that the US regulatory agency, the US Food and Drug Administration (FDA) has lifted the partial clinical hold on the company’s Phase 3 ‘Speed’ clinical trial that will evaluate the Viaskin Peanut patch. 250 μg modified in children aged 4 to 7 years. Thereafter, the updated protocol will be submitted to the clinical sites for subsequent approval by Personal Protection Committees (PPCs) and Ethics Committees (ECs).
DBV expects to begin patient screening in Q1 2023, with the last patient selected in H1 2024 and first results expected in H1 2025.
In the partial clinical suspension letter, the FDA requested changes to certain elements of this protocol so that the trial could serve as the basis for a biological license application (BLA). The FDA communication contained four protocol changes: redefinition of the minimum daily wear time, addition of a statistical test for assessment of patch adhesion, reclassification of certain adverse events as adverse events of special interest, and an increase in the number of participants in the active group.
“Key elements of the design of ‘Speed’, such as inclusion criteria, primary efficacy endpoint, response criteria, efficacy assessment methodology and safety endpoints, were not have not been impacted by the partial clinical suspension letter and have not been modified”, specifies the bio-pharmaceutical company at the clinical stage.
By lifting the partial clinical hold, the FDA has confirmed that DBV has satisfactorily addressed all of the points raised in the FDA’s clinical hold letter.
The company does not expect the additional job safety study requested by the FDA to impact its cash flow forecast, as it had factored the possibility of an additional safety study into its cash flow assumptions. . The company reaffirms that the available cash is sufficient to finance its operations until the results of ‘Speed’ are known.
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Loss of speed in European research
European research is losing ground to American and Chinese research. In twenty years, Europe’s share has fallen from 41% to 31% in global R&D. China’s share jumped from 1% to 8%. As for the United States, which supplanted Europe, in 2001 it devoted only 2 billion euros per year more than Europe to R&D, whereas now this gap has reached 25 billion! Some experts accuse the European authorities of not having deployed effective policies. The financing of pharmaceutical research should therefore have been better targeted via the “Horizon 2020” programme. France only comes in eighteenth position in European funding despite the quality of its research. Conversely, the United States concentrates funding on Boston and a few centers of excellence.