DBV Technologies SA's (DBVT:NASDAQ) Viaskin patch for peanut allergy in one to three-year-olds was shown to be effective and safe in a Phase 3 clinical trial, reported H.C. Wainwright & Co. analyst Andrew Fein in a June 8 research note. This is significant because no approved therapy exists for youngsters with this condition.
Generally, the EPITOPE trial demonstrated that 250 micrograms of Viaskin epicutaneous immunotherapy, after one year, achieved the primary endpoint of difference between the percentage of treatment responders in the active versus placebo cohorts.
Specifically, after one year, 67% of treated patients versus 33.5% of placebo patients met responder criteria, Fein relayed. This translates to a statistically significant response rate of 33.4% (p<0.001).
"We highlight that the lower bound of the 95% confidence interval was 22.4%, comfortably exceeding the prespecified 15% threshold," the analyst added.
The EPITOPE trial also showed the safety profile of Viaskin 250 micrograms in one to three-year-olds is consistent with that in children aged four years and older. Mild to moderate skin reactions at the patch site were the most common adverse events.
Fein pointed out that the safety profile of Viaskin is better than that of Palforzia, an approved oral peanut allergy drug for four to 17-year-olds. In EPITOPE, of the patients who received Viaskin, 1.6% had an anaphylactic reaction, from or not from the drug, which did not require epinephrine. This compares to 9.4% of patients with oral Palforzia, which occurred in trials not related to Viaskin.
Based on these positive EPITOPE data, DBV Technologies will continue advancing Viaskin toward approval in this early age group.
Fein highlighted that the French biopharma has a second shot on goal with Viaskin, and that is with a modified Viaskin patch for children ages four to 11 years. DBV Technologies has a Type C meeting with the U.S. Food and Drug Administration scheduled this quarter to discuss and finalize the protocol of the next planned trial in this regard, Phase 3 VITESSE.
"The main difference between the patches is the size and shape of the overlay itself, with the same occlusion chamber design, intended to satisfy optimized delivery," Fein explained.
H.C. Wainwright has a Buy rating and a $10 per share price target on DBV Technologies, the stock of which is currently trading around $2.85 per share.
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Disclosures for H.C. Wainwright & Co., DBV Technologies S.A., June 8, 2022
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.
I, Andrew S. Fein, Matthew Caufield, Andres Y. Maldonado, PhD and Ananda Ghosh, PhD , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst’s household has a financial interest in the securities of DBV Technologies S.A. (including, without limitation, any option, right, warrant, future, long or short position).
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The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
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