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Stallergenes: Oralair: Very Positive 3-Year Results of the Long-Term Study

Tuesday, December 8, 2009 Research News J E 4
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PARIS, December 7

- Very Positive 3-Year Results of the Long-Term Study ProvideConfirmation of the Clinical Relevance of Oralair(R)

Stallergenes S.A. today announces the 3-year results of a phase IIIclinical trial (VO53.06) to assess the long-term (sustained) effect anddisease modifier effect after discontinuation of treatment of its sublingualgrass pollen immunotherapy tablet, Oralair(R). This study is the first everpivotal study designed to be a long-term and disease modifier trial from theoutset.

The VO53.06 study is a randomized, double-blind, placebo-controlled phaseIII trial conducted over 5 years, 3 years as a pre- and coseasonal treatmentregimen and the following 2 years without treatment. It included 633patients, aged 18 to 50 years, with grass pollen-related allergicrhino-conjunctivitis, in 45 centers in 10 countries. The patients weredivided in two treated groups and one placebo group. In the two active arms,there was no dose escalation and the daily dose was a 300 IR sublingualimmunotherapy tablet. In one active arm, the treatment started 4 monthsbefore the pollen season, and in the other, 2 months before. The totaltreatment duration for each study-year in all groups was 5 to 6 months upuntil the end of the pollen season.

The sustained clinical efficacy as defined by EMEA[1] guidelines is themeasurement of treatment efficacy after 3 years. The primary endpoint was theAverage Adjusted Symptom Score (AASS)[2].

In the third year analysis, the two treated groups demonstrated astatistically significant reduction of AASS in comparison with placebo(p<0.0001) with a very large effect.

A reduction of 40% was achieved in the 2nd year and a reduction of 30% inthe 1st year (relative median differences versus placebo). These results notonly demonstrate the sustained clinical effect of Oralair(R) administeredusing a pre- and coseasonal treatment regimen but also suggest an increase inefficacy over the seasons.

In addition, each of the six individual symptom scores has demonstrated astatistically significant improvement. All the outcomes obtained in thesecondary endpoints were statistically significant and consistent with thoseof the primary endpoint.

Patient compliance was very satisfactory over the three seasons and theoverall tolerance was excellent.

In accordance with the recommendation of a board of independent experts(Data and Safety Monitoring Board), the study will be continued over the next2 years in order to assess the disease modifier effect (maintenance oftherapeutic benefit after treatment discontinuation).

In addition to this long-term study, in 2009 Stallergenes conducted aphase III one-season optimization study (VO60.08) with Oralair(R) 300 IR.This randomized, double-blind, placebo-controlled study was performed withoutdose escalation and used a 2-month pre-seasonal treatment regimen. In thistrial, 180 patients were enrolled in each of the two arms. The analysis onthe primary endpoint did not reach a statistically significant difference,although positive trends were demonstrated. Further in-depth analyses will beperformed, to identify likely methodological bias.

"We are very enthusiastic about the results of the VO53.06 study whichfar exceed our expectations. We will file for an extension of the product'scurrent labeling, as defined in the marketing authorization recently obtainedvia a Mutual Recognition Procedure (MRP) in 23 European countries. Suchsetbacks due to the VO60.08 study outcome can occur in any large developmentprogram, and in no way call into doubt the overall findings of the Oralair(R)program as a whole, which remain extremely consistent. The developmentprogram, which focuses on the benefit to patients and fits squarely withcurrent cost-containment trends, confirms the relevance of Stallergenes'strategic choices.

Our 2009 clinical news flow has been very dense and is not over yet.There are still more results to come and more analyses to be conducted. Wewill be delighted to present all these findings at an R&D day to be held atthe start of 2010." says Albert Saporta, Chairman and CEO of Stallergenes.

ABOUT ORALAIR(R)

The Oralair(R) clinical development program has demonstrated theshort-term efficacy of the product at an appropriate dose of 300 IR duringthe first season, through two clinical studies in adults and children(VO34.04 and VO52.06).

Through a pharmacodynamics study (V056.07), Stallergenes demonstratedthat its immunotherapy tablet had an effect on symptoms from the very firstmonth of treatment, without the use of rescue medication and irrespective ofvariable patient exposure to pollen.

The Oralair(R) development program, which has so far included over 1,800patients, makes the level of clinical evidence for this treatmentindisputable. This program, which was initiated in 2003 and is fully in linewith EMEA guidelines issued in 2008, will help immunotherapy tablets achievethe same level of recognition as conventional pharmaceuticals.

From the outset, the Oralair(R) clinical development program hasaddressed the key issues involved in grass pollen immunotherapy:

ABOUT THE STALAIR(R) PROGRAM

Stalair(R) is the pharmaceutical and clinical development program forimmunotherapy tablets being implemented by Stallergenes with a view toobtaining marketing registrations for pharmaceutical products in Europe andin other strategic markets.

Oralair(R) is the first project resulting from this program. A MutualRecognition Procedure has been completed. The results of a phase III clinicalstudy conducted in adults in the USA are expected in the coming weeks.

A positive phase IIb/III study was completed for the dust miteimmunotherapy tablet, Actair(R) in allergic rhinitis in adults during thefirst half of 2009. A pediatric phase III study has been launched.

The Bet v 1 tablet (birch pollen recombinant) has been the subject of apositive phase IIb/III clinical trial conducted in allergic rhinitis causedby birch pollen. A confirmatory phase III study is currently being preparedwith a view to EMEA registration.

The other allergens concerned by the program are ragweed for the NorthAmerican market and Japanese cedar pollen for the Japanese market.Altogether, the program covers 80% of the epidemiology for all markets.

ABOUT STALLERGENES

Stallergenes is a European biopharmaceutical company dedicated toimmunotherapy treatments for the prevention and treatment of allergy-relatedrespiratory diseases, such as allergic rhinoconjunctivitis, rhinitis andasthma. As of today, Stallergenes is the seventh-ranked French pharmaceuticalcompany. A pioneer and leader in sublingual immunotherapy treatments,Stallergenes devotes 21% of its turnover, in gross terms, to Research andDevelopment and is actively involved in the development of a new therapeuticclass: sublingual immunotherapy tablets.

In 2008, Stallergenes had a turnover of 171 million euros and more than500,000 patients were treated with Stallergenes immunotherapy products.

[2] AASS: Average Adjusted Symptom Score: A score taking into account thedaily rhino-conjunctivitis total symptoms score and rescue medication usage.Relative differences versus placebo (season 3) 2 months 4 months Mean -36% -34% Median -50% -48%

SOURCE Stallergenes
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