DBV Technologies is wasting no time capitalising on positive results from a phase IIb trial of its peanut allergy project. The French firm also today unveiled plans for a sizeable fundraising in the US that could net $96m, the proceeds of which look likely to fund a pivotal programme.
This looks most likely to be carried out only in children and possibly adolescents; data from the phase IIb study, called Vipes, generated inconclusive results in adults. However the signal was strong enough for investors to send Paris-listed shares in the company 23% higher to a record €31.27, valuing the allergy specialist at a respectable €480m ($620m).
According to an SEC filing the company plans to issue 3 million new shares to US investors via its existing ADS scheme. These will be sold at a maximum of $32 a share, in line with the current US-listed share price. Because the company is now in a quiet period executives would not respond to questions, but it seems likely that the majority of these funds will be spent on getting Viaskin Peanut to the market.
Vipes was a double-blind, placebo-controlled study conducted in the US and Europe, recruiting 221 people with peanut allergy, who were randomised into four treatment arms that received 50µg, 100µg or 250µg doses of Viaskin Peanut, or placebo (Upcoming events: Intarcia and DBV await crucial data while Salix looks to FDA, September 12, 2014).
Viaskin Peanut – which the company describes as an epicutaneous immunotherapy – is a patch-based therapy. Subjects were treated with a new patch every day for 12 months, and their reaction tested at the start and end of the year.
The primary efficacy endpoint was the percentage of treatment responders for each active treatment compared with placebo. For a patient to be defined as a treatment responder they had to show a tenfold increase in the dose of peanut protein to cause a reaction, or start to react at a dose of at least 1,000mg of peanut protein, the equivalent of about four peanuts.
DBV only released results from the highest-dose group – which included 56 patients – saying that this showed the strongest results statistically. Half of these patients were classified as responders at the end of the trial, compared with a quarter of the placebo group (p=0.0108).
Out of the 56 patients in the 250µg group, 28 of these were children. This subgroup also saw significantly more responders in the treatment arm, 54% against 19% (p=0.008), and registered a significant increase in peanut protein consumption, a secondary endpoint. Various biomarkers suggested a “powerful desensitising effect”, DBV said.
Results in the 18 adolescents did not meet the primary endpoint but the secondary measure of peanut protein consumption did hit significance, and biomarkers suggested the beginning of the desensitisation process, the company said. Results from the adult subgroup were inconclusive due to a small sample size and a high placebo effect, it added.
However, concerns about the small sample size can be levelled at all age subgroups. The adult group only had 10 patients who received the 250µg dose and not many more adolescents.
The substantial fundraising announced today suggests that DBV is readying for phase III. Based on these results, this would likely test the high dose and include children.
Adults surely have to be ruled out at this stage, but the inclusion of adolescents remains an unknown. This would make the trial higher risk, but at the same time significantly increase the addressable market.
The appropriate dose also remains unanswered as it seems DBV could have got away with more. It flagged an impressively low 6.4% dropout rate across the trial, lower than an expected 15%, and reported no serious treatment-related adverse events. This would seem to indicate that that at the lower doses the patch was increasingly benign, in terms of both efficacy and tolerability.
With what looks like a miscalculation on the doses tested and the addressable patient population far from defined, there are good reasons for DBV to push forward cautiously.