Seeking Alpha • Jul 07
DBV Technologies: Good Data, Plenty Of Cash And Regulatory Uncertainty
DBV Technologies is a French company traded on Nasdaq which is developing treatments for food allergies.
Their technology is a patch that delivers a very small daily dose of the allergen to desensitize the patient.
The company previously received a CRL due to issues with the adhesion properties of their patch.
The Phase 3 EPITOPE trial met the primary endpoint with a good safety profile.
FDA feedback on the regulatory path is the next critical catalyst for the company.
DBV Technologies (DBVT) is developing an epicutaneous (on the skin) delivery system for the treatment of food allergies including peanuts and milk. After completing a Phase 3 trial in children ages 4-11, the company received a CRL from the FDA for their Viaskin peanut patch due to concerns about patch adhesion. The company redesigned the patch and will need to run a new Phase 3 trial using the modified patch for this age group. Recently, using the unmodified patch, the EPITOPE study met the primary endpoint in children ages 1-4. DBV Technologies is well capitalized after a recent raise that occurred after the EPITOPE readout. There is considerable uncertainty about the regulatory path but longer term these assets, if approved have significant value.
Peanut Allergies and Treatment Options
There are more than one million children in the US with peanut allergies. The prevalence in babies is increasing and as many as 5% of babies have a peanut allergy. Avoidance of peanuts is the primary strategy but accidental exposure can result in severe reactions.
Allergy treatments gradually increase the quantity of allergen that a child is exposed to. The goal of treatment is to desensitize the child and increase the quantity of peanut that elicits an allergic reaction.
There are no FDA-approved treatments for peanut allergies in children ages 1-3. At age 4, children would become eligible for Palforzia which is an oral immunotherapy. It is newly approved and can only be prescribed by a trained allergist and requires an FDA mandated risk mitigation plan due to the risk of anaphylaxis.
In the Palforzia program, under the supervision of a trained physician, children ingest increasing amounts of peanut protein. Dose escalation occurs in a certified physician’s office. At dose escalation, 67 % of patients reported abdominal pain, 36.5% experienced vomiting, 32% reported nausea and 31% reported oral itching. There was a 9.4 % rate of anaphylaxis during dose escalation and 8.7% during maintenance dosing. At the end of treatment, 67% of Palforzia patients could tolerate a 600 mg dose of peanuts. (600 mg is approximately 2 peanuts).
The EPITOPE study met the primary endpoint
Toddlers aged 1-3 who have a peanut allergy were enrolled in the clinical trial. On a daily basis, their caregivers applied a Viaskin peanut patch. The patch at the highest dose contains 250 micrograms of peanut protein which is a very, very small amount of peanut protein. (A microgram is one thousandth of an mg.)
The EPITOPE trial was one year in duration. 244 toddlers received treatment and 118 received placebo. At baseline and at the end of treatment, toddlers received a food challenge to determine their eliciting dose. The eliciting dose is the amount of peanut that causes allergic symptoms. At the end of treatment, patients who were successfully treated made the improvements shown in the chart below.
Before Treatment
After Treatment
Eliciting dose less than or equal to 10 mg
Eliciting dose greater than or equal to 300 mg
Eliciting dose greater than 10 mg
Eliciting dose greater than or equal to 1000 mg
Source: DBV Technologies
67% of children treated met the "success" response criteria at 12 months. In comparison, 33.5 % of placebo treated children met the endpoint. (Note: The placebo response was likely a result of a self resolving peanut allergy.) This result was statistically significant and the primary endpoint was met.
In the trial, there was one SAE which was swelling around the eye. The most common side effect was a reaction at the site where the patch was applied. 22.5 % of the children experienced a site reaction that was severe as compared to 8.5% of placebo patients. These reactions decreased during the one year treatment period. Eight children discontinued treatment due to side effects.
Four children (1.6%) treated with Viaskin Peanut experienced an anaphylactic reaction that was determined to be or may have been related to treatment. None of these anaphylactic reactions were serious. Three of these reactions resolved with epinephrine and one without epinephrine. A long term open label extension study is underway.
Revenue Projections
