BRUSSELS—More than 400 million people suffer from allergic rhinitis, and one of every three such people is not adequately controlled by symptomatic pharmacotherapy. Grass pollen is one of the most common allergies in the world, and ASIT Biotech (formerly Biotech Tools), as a clinical-stage biopharmaceutical company specializing in allergy immunotherapy, hopes to improve the possibilities of desensitization treatment that can be administrated to patients.
“Desensitization treatments for patients suffering from grass pollen rhino-conjunctivitis are often long and cumbersome, presenting a low rate of acceptance and compliance,” according to Thierry Legon, CEO of ASIT Biotech. “The treatment consists of a mixture containing highly purified peptides of selected sizes, produced from natural sources of allergens and free of adjuvant. With subcutaneous injections over four doctors’ visits in three weeks prior to the pollen season, we aim to protect patients from the negative effects of their allergy to grass pollen for the whole duration of the pollen season.”
The company will launch a confirmatory Phase 3 clinical study with gp-ASIT+ in grass pollen rhinitis prevention. gp-ASIT+ consists of a mixture of natural allergen fragments obtained from a purified specific proteinic extract from Lolium perenne pollen. In contrast to synthesized peptides, the natural peptides include a wide range of epitopes that stimulate the immune system with optimal complexity. Study results are expected in December 2019.
Based on the lessons learned from the first Phase 3 study, major improvements have been implemented to maximize the probability of success of this confirmatory Phase 3 study. ASIT biotech has developed nine major improvements:
- Subcontracting the new Phase 3 study to a single contract research organization (CRO), ICON plc, a global provider of outsourced drug development and commercialization solutions
- Executing oversight internally by a well-staffed clinical operations team
- Using high pollen count and high-quality data recording history to select the relevant clinical centers
- Involving 82 clinical centers across six countries (Germany, Belgium, France, the Czech Republic, Hungary and Poland) in the current Phase 3 clinical study and limiting each center to a maximum number of randomized patients
- Requiring a medical history of moderate to severe pollen allergy over the last two years for each patient to randomize the most allergic ones
- Monitoring patient recruitment at each clinical site online in line with a provisional schedule established using historical regional grass pollen data for the last five pollen seasons
- Using electronic diaries to improve patient commitment to better data recording and quality
- Centralizing pollen count monitoring by the European Aeroallergen Network from the University of Vienna to guarantee the reliability of the pollen count data used for statistical analysis
- Making the launch date earlier than for the first Phase 3 study, allowing for a longer randomization and treatment period prior to the grass pollen season.
Legon said that the new process improvements would help to answer the main challenges that this kind of trial can encounter, such as imprecise pollen season dates, selection of a patient population with relatively weak allergies, and missing data or inhomogeneous monitoring by different CROs. Furthermore, internal supervision will be reinforced and run by an experienced operational senior team.
He added: “ICON will be the only CRO allowed in this clinical study, and was selected in regards of its large experience in the field of allergy clinical studies. With its worldwide localizations and experience, we are convinced that ICON is the best choice for obtaining the most performing study management possible.”
In total, 624 patients with grass pollen allergy will be enrolled in the study. The first patient visit is expected in January 2019, and the last patient last visit in September 2019, enabling the company to obtain the study results in December 2019. The primary objective is a 20-percent reduction in the combined clinical symptom and medication score (CSMS) in the treated group compared to placebo.
The first Phase 3 of ASIT biotech in grass rhinitis was launched in January 2016 following results from the Phase 1 and 2 trials that showed promising efficacy of gp-ASIT+ versus placebo. However, due to a weak pollen season in some of the participating countries, the Phase 3 results were not as compelling.
Legon concluded: “The allergy treatment market is large and in constant augmentation. It is estimated at $12 billion, with the sole immunotherapy treatments market estimated at $1.8 billion. Should gp-ASIT+ prove its efficacy in the second Phase 3 initiated in November 2018, the product would more than likely find a place in this huge market.”