DBVT stock is moving higher in pre-market trading on January 9, 2020, after Stifel upgraded the stock.
Stifel analyst Derek Archila upgraded DBV Technologies to Buy from Hold with a price target of $18, up from $10. DBV reported three-year PEPITES data, which is suggestive that Viaskin peanut provides increasing levels of protection from peanut exposure with continued treatment beyond one year, Archila tells investors in a research note. The analyst believes the results are “derisking,” particularly in the context of a potential FDA advisory committee. The stock will continue to work into a potential positive FDA panel and approval later this year, says Archila.
DBV Technologies (the “Company”) (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, announced positive topline results of the three-year, open-label extension of the Phase III PEPITES trial (PEOPLE) evaluating the long-term efficacy and safety of investigational Viaskin® Peanut in peanut-allergic children ages 4 to 11 years. The results demonstrate long-term clinical benefit as shown by an increase in eliciting dose (ED), which may decrease the chance of reacting to an accidental peanut exposure. After three years, 75.9% (107/141) of patients had increased their ED from baseline, and 51.8% (73/141) of patients reached an ED of at least 1,000 mg peanut protein by year three.
“These new long-term data support the overall clinical benefit of Viaskin Peanut that we’ve observed to date in Phase II and III clinical trials. We are particularly pleased to see that approximately three out of four patients showed an increase in their eliciting dose over three years, regardless of their individual baseline, with roughly 1 in 7 patients able to consume 5,444 mg peanut protein without reacting during the Month 36 oral food challenge,” said Dr. David Fleischer, Principal Investigator of PEPITES and PEOPLE, Director, Allergy and Immunology Center and Section Head, Children’s Hospital Colorado. “Most peanut-allergic children react to a single peanut (300 mg of peanut protein) or less, with some reacting to as little as 1 mg, leading many children and families to experience constant fear of accidental exposure, loss of normalcy and decreased quality of life. These new data provide further evidence that Viaskin Peanut may reduce the risk of reaction from accidental exposure by increasing threshold reactivity through a treatment option that could be safe and convenient.”
The PEOPLE study is an ongoing open-label extension study evaluating the long-term safety, tolerability and efficacy of Viaskin Peanut 250 μg in patients who have completed the Phase III PEPITES trial. Of the 213 patients who were randomized in the active treatment arm of PEPITES and completed the 12-month trial, 198 patients opted to enter the PEOPLE study (safety population). Of these patients, 148 were considered completers after 36 months and 141 patients completed all treatment according to the study protocol without major deviations. Efficacy data were analyzed from these 141 patients (per-protocol).
Topline results from PEOPLE support the long-term tolerability and clinical benefit of Viaskin Peanut, demonstrating desensitization over 36 months of treatment. After 36 months, 51.8% (73/141) of patients reached an ED of at least 1,000 mg peanut protein, an increase relative to Month 12, 40.4% (57/141). In addition, 13.5% (19/141) of patients completed the food challenge without meeting stopping criteria at 36 months (cumulative dose of 5,444 mg). At Month 36, the mean cumulative reactive dose (CRD) was 1,768.8 mg (median 944 mg) compared to 223.8 mg (median 144 mg) at baseline.
The safety profile of Viaskin Peanut was consistent with that observed in the clinical program to date in over 1,000 patients. During PEOPLE, the most common adverse events were mild to moderate skin reactions localized to the administration site and there was no epinephrine use deemed related to treatment. No treatment related serious adverse events (SAEs) were reported. One patient experienced one case of mild anaphylaxis that was determined by the investigator to be possibly related to treatment and resolved without treatment. Treatment compliance remained high throughout the study at a mean of 98% over three years of treatment.
Exploratory analyses suggest Viaskin Peanut may offer sustained effect even after a period without treatment. All participants who reached an ED ≥ 1,000 mg at Month 36 were eligible to continue the study for two additional months without treatment while maintaining a peanut-free diet. A further double-blind placebo-controlled food challenge to determine ED was administered at the end of this period (Month 38). The analysis showed that 77.8% (14/18) of the children who completed the oral food challenge at Month 38 maintained desensitization with an ED ≥ 1,000 mg.
“Harnessing the important immune properties of the skin, epicutaneous immunotherapy represents a potentially unique mechanism of action that may support the sustained desensitization observed in this study even after a period without treatment. These data further advance our understanding of the profile of Viaskin Peanut, which is currently under review by the U.S. Food and Drug Administration and may offer a simple, once daily, non-invasive treatment option for children living with peanut allergy in the second half of 2020, if approved,” said Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies. “Importantly, we would like to thank the children, families and investigators for participating in this study, the largest long-term trial in this underserved disease.”
The Company plans to present full study results at future medical congresses as well as submit for publication in a peer-reviewed journal.
On January 2, 2020, DBV Technologies announced the appointment of Ramzi Benamar as its Chief Financial Officer (CFO), effective January 6, 2020. Ramzi will serve as a member of the Executive Committee and report to Daniel Tassé, Chief Executive Officer of DBV Technologies.
Daniel Tassé stated, “I am thrilled to have Ramzi join DBV in the critical role of CFO, bringing tremendous financial leadership capabilities, a focus on capital deployment strategies, and a rich background in both R&D and commercial biotechnology companies. As we continue to prepare for the potential approval of Viaskin Peanut, I believe Ramzi’s financial planning experience and track record of business and portfolio building, will help drive DBV through our next stages of growth.”
Ramzi brings more than two decades of experience in biopharmaceutical finance and business operations roles. He most recently served as Vice President and Head of Financial Planning and Analysis for Spark Therapeutics, where he reported directly to the CFO, providing financial leadership across the company and supporting the design and implementation of product launch plans, including pricing strategy, marketing, sales, market access, contracting and distribution. Previously, Ramzi held various positions of increasing responsibilities in R&D finance, as well as in Analytics, Strategy and Operations at Merck, Johnson & Johnson and Shire Plc. Ramzi earned both his M.B.A and B.B.A in Marketing and Finance from Temple University, and his Master of Healthcare and Pharmaceutical Business Administration from University of the Sciences in Philadelphia. Originally from Lyon, France, Ramzi speaks fluent French and English. He will be based in the U.S. but spend a significant amount of time in France.
“I look forward to joining DBV’s experienced and driven team at this very exciting time in the company’s evolution,” said Ramzi Benamar. “I am impressed with the potential of the Viaskin technology platform and look forward to working with Daniel, and everyone at DBV in their mission to bring innovative treatments to patients with food allergies and other immunological diseases. Additionally, as the parent of a child who suffers from a food allergy, I understand the seriousness and burden of food allergies on patients and caregivers, as well as the pressing need for treatment options.”
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