LOS ANGELES, CA, USA I March 5, 2016 I Stallergenes Greer, a leading developer and provider of allergy immunotherapy products and services, today released the findings from several new studies highlighting advances in its allergy immunotherapy portfolio at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2016 Annual Meeting in Los Angeles, Calif. Presentations included findings from studies evaluating Stallergenes Greer’s sublingual tablets for certain grass allergies, as well as the company’s investigational product currently being studied for house dust mites allergies. The company is also presenting findings from an evaluation of a commercially-available Nanotechnology platform for the characterization of proteins, antigens and allergens in extracts and source materials.
ORALAIR® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for Sublingual Use in Polysensitized Patients
This presentation evaluates the efficacy of 300IR ORALAIR in patients who are polysensitized or allergic to more than one type of allergen. In this analysis, subjects ages 5 to 56 with medically confirmed grass pollen-induced allergic rhinoconjunctivitis for at least two years underwent prick skin testing to 5-grass mix or timothy and a panel of geographically relevant airborne allergens. Those who had a positive test to 5-grass/timothy and at least one other non-grass allergen were considered polysensitized and received either ORALAIR or placebo four months prior to and until the end of the grass pollen season. Every day subjects self-scored each of their rhinitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion) on a scale from zero (none) to three (severe). The individual symptom scores and the Rhinitis Total Symptom Score, the sum of the four individual symptom scores, were analyzed descriptively.
Data from 891 polysensitized subjects, corresponding to 65 percent of the studied population, were analyzed. The means of each of the individual symptom scores in the 300IR group (n=427) were significantly lower than in the placebo group (n=464) with relative differences from placebo of -15 percent (sneezing), -19 percent (rhinorrhea), -22 percent (nasal pruritus) and 24 percent (nasal congestion). The Rhinitis Total Symptom Score relative mean difference from placebo was -20 percent.
Consistent with the overall population, oral pruritus and throat irritation were the most commonly reported adverse events. One subject reported a severe hypersensitivity reaction and recovered with oral corticosteroid and antihistamine. The presentation concluded that ORALAIR 300IR significantly reduces individual and total symptom scores in polysensitized subjects with grass pollen-induced rhinoconjunctivitis.
“The findings of this analysis provide valuable insights into how we treat grass allergy patients here in the U.S.,” said Olivier de Beaumont, Stallergenes Greer global medical affairs vice president. “We know that many Americans are polysensitized, leaving questions as to how allergy immunotherapy tablets can be used to effectively treat grass pollen symptoms when patients have multiple allergy triggers. This study confirms that ORALAIR is an effective treatment in symptom scores for grass pollen allergies in polysensitized patients. Our goal is that this information will help guide allergy specialists as they work with their grass allergy patients to map out their allergy treatment plan and the role of allergy immunotherapy.”
The prescribing information for ORALAIR includes a Boxed Warning regarding the potential for severe allergic reactions. Please see below for a summary of the Boxed Warning and additional important safety information.
Stallergenes Greer Investigational House Dust Mite Tablet Studies
An analysis was performed to evaluate the efficacy of Stallergenes Greer investigational sublingual tablets of house dust mite allergen (STG320). Adults with house dust mite-associated allergic rhinitis were enrolled in a natural field study and an environmental exposure chamber study. A total of 509 patients in the natural field study received STG320 500IR, 300IR or placebo once daily for one year. In the chamber study, 355 patients received 500IR, 300IR, 100IR or placebo daily for six months. The Average Rhinitis Total Symptom Score (ARTSS) and individual rhinitis symptom scores (sneezing, rhinorrhea, nasal pruritus, nasal congestion) were assessed over the last three months of treatment. In the chamber study, the changes from baseline to end-of-6-month-treatment in ARTSS (ChBLARTSS) and individual symptoms were assessed over the four hours and the last two hours of house dust mite exposure.
In the natural field study ARTSS were significantly reduced (p<0.05) with relative differences from placebo of -17.4 percent (500IR) and -18.5 percent (300IR). In the active groups, the scores for all recorded symptoms were lower than placebo, with significance at both doses for sneezing and nasal pruritus, and at 300IR for nasal congestion. In the chamber study, relative differences from placebo increased from 17.5 percent (100IR) to 25.8 percent (300IR) and 31.1 percent (500IR) for ChBLARTSS0-4h, and 31.3 percent (100IR) to 42.3 percent (300IR) and 44.7 percent (500IR) for ChBLARTSS2-4h. The changes from baseline to the end-of-6-month-treatment in individual scores also improved with the increase in dose. The studies achieved their endpoints.
Additionally, Stallergenes Greer presented a late-breaking abstract of pooled safety data for STG320. In this pooled analysis, 2,407 subjects (1,718 adults, 443 adolescents, 246 children) received placebo or STG320 at doses from 100IR to 1500IR. A total of 627 subjects (26 percent) had intermittent asthma at enrollment. In the pooled analysis, 64 percent of actively treated subjects and 20 percent of placebo recipients reported treatment emergent adverse events (TEAEs) suspected to be drug related. These were mostly consistent with mild or moderate application site reactions including throat irritation (23 percent), oral pruritus (17 percent), mouth edema (14 percent), ear pruritus (12 percent) and mainly reported over the initial four weeks. The percentage of subjects with drug related TEAEs was similar in those with and without asthma in active (59 percent and 66 percent) and placebo (19 percent and 20 percent) groups. Four subjects reported serious drug related TEAEs (three active: eczema, pharyngeal edema and dyspnea, and one placebo: urticaria). In the active treatment group eight percent of patients and three percent on placebo discontinued treatment mainly as a result of application site reactions. There were no reports of anaphylaxis and no epinephrine use.
“These studies provide key learnings as Stallergenes Greer continues to expand its portfolio of allergy immunotherapy treatments,” said Rick Russell, Stallergenes Greer president and CEO. “Confirming that ORALAIR significantly reduces symptom scores in polysensitized patients is a major milestone. That paired with the advancement of our house dust mite tablet pipeline are the latest examples of how we are redefining the allergy immunotherapy space and leading the industry in allergy immunotherapy innovation.”
The fourth poster entitled ‘A promising Technology for Characterizing Proteins, Antigens and Allergens in Extracts and Source Material,’ evaluates a Nanotechnology called WES, manufactured by ProteinSimple, and compares results to the traditional technologies (SDS-PAGE/Western blotting). Based on Stallergenes Greer’s results, WES provided not only very similar qualitative protein and antigenic band patterns as the traditional SDS-PAGE/Western blotting but demonstrated quantitative capabilities beyond those of traditional methods. Consequently, WES has the potential of providing useful qualitative and quantitative data for total protein and immunoassay applications with allergenic extracts and the screening/qualifying of source material lots for extract manufacturing. Additional analyses and comparison studies are needed to determine the applications of this emerging nanotechnology platform to other allergens or proteins of biomedical interest.
For more information or to download copies of the presentations visit http://annualmeeting.aaaai.org.
ABOUT STALLERGENES GREER
Headquartered in London (UK), Stallergenes Greer plc is a global company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the U.S.) and Stallergenes SAS (whose registered office is in France).
Additional information is available at www.stallergenesgreer.com.
About ORALAIR® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract)
ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the 5 grass species contained in this product. ORALAIR is approved for use in persons 10 through 65 years of age.
ORALAIR is not indicated for the immediate relief of allergy symptoms.
Important Safety Information
WARNING: SEVERE ALLERGIC REACTIONS
- ORALAIR can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal edema.
- Do not administer ORALAIR to patients with severe, unstable or uncontrolled asthma.
- Observe patients in the office for at least 30 minutes following the initial dose.
- Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.
- ORALAIR may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction.
- ORALAIR may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.
ORALAIR is contraindicated in patients with severe, unstable or uncontrolled asthma, patients with a history of any severe systemic allergic reaction or severe local reaction to sublingual allergen immunotherapy or of eosinophilic esophagitis, or patients who are hypersensitive to any of the inactive ingredients.
ORALAIR can cause systemic allergic reactions, including anaphylaxis, and severe local reactions, including laryngopharyngeal swelling, which may be life-threatening. Severe and serious allergic reactions may require treatment with epinephrine. Patients who have a systemic allergic reaction to ORALAIR should stop taking the product. Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy. Discontinue ORALAIR in patients with persistent symptoms of eosinophilic esophagitis, including dysphagia or chest pain. ORALAIR treatment should be withheld if the patient is experiencing an acute asthma exacerbation. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of ORALAIR. Concomitant dosing with other allergen immunotherapy may increase the likelihood of local or systemic adverse reactions to either subcutaneous or sublingual allergen immunotherapy.
In case of oral inflammation or wounds, such as following oral surgery or dental extraction, ORALAIR treatment should be discontinued to allow complete healing of the oral cavity. The risk of ORALAIR may be increased when treatment is initiated during the grass pollen season.
The most common adverse events reported in ≥5% of patients were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, and oropharyngeal pain. Patients who have escalating or persistent local reactions to ORALAIR should be reevaluated and considered for discontinuation of ORALAIR.
ORALAIR should be used during pregnancy or breastfeeding only if clearly needed.
Please see full Prescribing Information, including Boxed Warning and Medication Guide, for additional important safety information.
About STG320
STG320 is being studied for the treatment of house dust mite (HDM)-associated allergic rhinitis. More than 2400 patients have been enrolled in the rhinitis program consisting of adults, adolescents, and children (at least 5 years of age) with history of HDM-associated allergic rhinitis for at least 1 year and a specific sensitization to HDM allergens confirmed by clinically relevant symptoms, a positive cutaneous test for HDM allergies and/or a positive test for the specific IgE to HDM.
The results of the natural field and environmental exposure chamber studies demonstrate that the 500 IR and 300 IR doses of STG320 were similarly efficacious in treating adults with HDM-induced allergic rhinitis. In the natural field study which followed patients post-treatment, efficacy was maintained over a treatment-free follow-up year. Efficacy of both active doses in adolescents was demonstrated. A favorable safety and tolerability profile was observed for all tested doses. No deaths were reported. There were no reports of anaphylactic shock, anaphylaxis, or Intensive Care Unit admission and no use of epinephrine. The most frequent adverse events were application site reactions such as oral pruritus and throat irritation. Most were of mild or moderate severity and were reported during the first weeks of treatment. Treatment-related adverse events leading to premature discontinuation were more frequent with active treatment than placebo, and slightly more frequent with the 500 IR compared to 300 IR. The safety profile in children and adolescents was similar to that observed in adults.
In March 2015, following completion of a randomized, double-blind and placebo controlled study evaluating the efficacy and safety of a 12 month course of treatment with STG320 sublingual immunotheraapy tablets, the Japanese Pharmaceuticals and Medical Devices Agency approved STG320 as the first immunotherapy tablet for the treatment of HDM induced allergy in children and adults. Outside of Japan, STG320 is an investigational drug which has not been approved.
SOURCE: Stallergenes
Post Views: 230
LOS ANGELES, CA, USA I March 5, 2016 I Stallergenes Greer, a leading developer and provider of allergy immunotherapy products and services, today released the findings from several new studies highlighting advances in its allergy immunotherapy portfolio at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2016 Annual Meeting in Los Angeles, Calif. Presentations included findings from studies evaluating Stallergenes Greer’s sublingual tablets for certain grass allergies, as well as the company’s investigational product currently being studied for house dust mites allergies. The company is also presenting findings from an evaluation of a commercially-available Nanotechnology platform for the characterization of proteins, antigens and allergens in extracts and source materials.
ORALAIR® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for Sublingual Use in Polysensitized Patients
This presentation evaluates the efficacy of 300IR ORALAIR in patients who are polysensitized or allergic to more than one type of allergen. In this analysis, subjects ages 5 to 56 with medically confirmed grass pollen-induced allergic rhinoconjunctivitis for at least two years underwent prick skin testing to 5-grass mix or timothy and a panel of geographically relevant airborne allergens. Those who had a positive test to 5-grass/timothy and at least one other non-grass allergen were considered polysensitized and received either ORALAIR or placebo four months prior to and until the end of the grass pollen season. Every day subjects self-scored each of their rhinitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion) on a scale from zero (none) to three (severe). The individual symptom scores and the Rhinitis Total Symptom Score, the sum of the four individual symptom scores, were analyzed descriptively.
Data from 891 polysensitized subjects, corresponding to 65 percent of the studied population, were analyzed. The means of each of the individual symptom scores in the 300IR group (n=427) were significantly lower than in the placebo group (n=464) with relative differences from placebo of -15 percent (sneezing), -19 percent (rhinorrhea), -22 percent (nasal pruritus) and 24 percent (nasal congestion). The Rhinitis Total Symptom Score relative mean difference from placebo was -20 percent.
Consistent with the overall population, oral pruritus and throat irritation were the most commonly reported adverse events. One subject reported a severe hypersensitivity reaction and recovered with oral corticosteroid and antihistamine. The presentation concluded that ORALAIR 300IR significantly reduces individual and total symptom scores in polysensitized subjects with grass pollen-induced rhinoconjunctivitis.
“The findings of this analysis provide valuable insights into how we treat grass allergy patients here in the U.S.,” said Olivier de Beaumont, Stallergenes Greer global medical affairs vice president. “We know that many Americans are polysensitized, leaving questions as to how allergy immunotherapy tablets can be used to effectively treat grass pollen symptoms when patients have multiple allergy triggers. This study confirms that ORALAIR is an effective treatment in symptom scores for grass pollen allergies in polysensitized patients. Our goal is that this information will help guide allergy specialists as they work with their grass allergy patients to map out their allergy treatment plan and the role of allergy immunotherapy.”
The prescribing information for ORALAIR includes a Boxed Warning regarding the potential for severe allergic reactions. Please see below for a summary of the Boxed Warning and additional important safety information.
Stallergenes Greer Investigational House Dust Mite Tablet Studies
An analysis was performed to evaluate the efficacy of Stallergenes Greer investigational sublingual tablets of house dust mite allergen (STG320). Adults with house dust mite-associated allergic rhinitis were enrolled in a natural field study and an environmental exposure chamber study. A total of 509 patients in the natural field study received STG320 500IR, 300IR or placebo once daily for one year. In the chamber study, 355 patients received 500IR, 300IR, 100IR or placebo daily for six months. The Average Rhinitis Total Symptom Score (ARTSS) and individual rhinitis symptom scores (sneezing, rhinorrhea, nasal pruritus, nasal congestion) were assessed over the last three months of treatment. In the chamber study, the changes from baseline to end-of-6-month-treatment in ARTSS (ChBLARTSS) and individual symptoms were assessed over the four hours and the last two hours of house dust mite exposure.
In the natural field study ARTSS were significantly reduced (p<0.05) with relative differences from placebo of -17.4 percent (500IR) and -18.5 percent (300IR). In the active groups, the scores for all recorded symptoms were lower than placebo, with significance at both doses for sneezing and nasal pruritus, and at 300IR for nasal congestion. In the chamber study, relative differences from placebo increased from 17.5 percent (100IR) to 25.8 percent (300IR) and 31.1 percent (500IR) for ChBLARTSS0-4h, and 31.3 percent (100IR) to 42.3 percent (300IR) and 44.7 percent (500IR) for ChBLARTSS2-4h. The changes from baseline to the end-of-6-month-treatment in individual scores also improved with the increase in dose. The studies achieved their endpoints.
Additionally, Stallergenes Greer presented a late-breaking abstract of pooled safety data for STG320. In this pooled analysis, 2,407 subjects (1,718 adults, 443 adolescents, 246 children) received placebo or STG320 at doses from 100IR to 1500IR. A total of 627 subjects (26 percent) had intermittent asthma at enrollment. In the pooled analysis, 64 percent of actively treated subjects and 20 percent of placebo recipients reported treatment emergent adverse events (TEAEs) suspected to be drug related. These were mostly consistent with mild or moderate application site reactions including throat irritation (23 percent), oral pruritus (17 percent), mouth edema (14 percent), ear pruritus (12 percent) and mainly reported over the initial four weeks. The percentage of subjects with drug related TEAEs was similar in those with and without asthma in active (59 percent and 66 percent) and placebo (19 percent and 20 percent) groups. Four subjects reported serious drug related TEAEs (three active: eczema, pharyngeal edema and dyspnea, and one placebo: urticaria). In the active treatment group eight percent of patients and three percent on placebo discontinued treatment mainly as a result of application site reactions. There were no reports of anaphylaxis and no epinephrine use.
“These studies provide key learnings as Stallergenes Greer continues to expand its portfolio of allergy immunotherapy treatments,” said Rick Russell, Stallergenes Greer president and CEO. “Confirming that ORALAIR significantly reduces symptom scores in polysensitized patients is a major milestone. That paired with the advancement of our house dust mite tablet pipeline are the latest examples of how we are redefining the allergy immunotherapy space and leading the industry in allergy immunotherapy innovation.”
The fourth poster entitled ‘A promising Technology for Characterizing Proteins, Antigens and Allergens in Extracts and Source Material,’ evaluates a Nanotechnology called WES, manufactured by ProteinSimple, and compares results to the traditional technologies (SDS-PAGE/Western blotting). Based on Stallergenes Greer’s results, WES provided not only very similar qualitative protein and antigenic band patterns as the traditional SDS-PAGE/Western blotting but demonstrated quantitative capabilities beyond those of traditional methods. Consequently, WES has the potential of providing useful qualitative and quantitative data for total protein and immunoassay applications with allergenic extracts and the screening/qualifying of source material lots for extract manufacturing. Additional analyses and comparison studies are needed to determine the applications of this emerging nanotechnology platform to other allergens or proteins of biomedical interest.
For more information or to download copies of the presentations visit http://annualmeeting.aaaai.org.
ABOUT STALLERGENES GREER
Headquartered in London (UK), Stallergenes Greer plc is a global company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the U.S.) and Stallergenes SAS (whose registered office is in France).
Additional information is available at www.stallergenesgreer.com.
About ORALAIR® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract)
ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the 5 grass species contained in this product. ORALAIR is approved for use in persons 10 through 65 years of age.
ORALAIR is not indicated for the immediate relief of allergy symptoms.
Important Safety Information
WARNING: SEVERE ALLERGIC REACTIONS
- ORALAIR can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal edema.
- Do not administer ORALAIR to patients with severe, unstable or uncontrolled asthma.
- Observe patients in the office for at least 30 minutes following the initial dose.
- Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.
- ORALAIR may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction.
- ORALAIR may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.
ORALAIR is contraindicated in patients with severe, unstable or uncontrolled asthma, patients with a history of any severe systemic allergic reaction or severe local reaction to sublingual allergen immunotherapy or of eosinophilic esophagitis, or patients who are hypersensitive to any of the inactive ingredients.
ORALAIR can cause systemic allergic reactions, including anaphylaxis, and severe local reactions, including laryngopharyngeal swelling, which may be life-threatening. Severe and serious allergic reactions may require treatment with epinephrine. Patients who have a systemic allergic reaction to ORALAIR should stop taking the product. Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy. Discontinue ORALAIR in patients with persistent symptoms of eosinophilic esophagitis, including dysphagia or chest pain. ORALAIR treatment should be withheld if the patient is experiencing an acute asthma exacerbation. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of ORALAIR. Concomitant dosing with other allergen immunotherapy may increase the likelihood of local or systemic adverse reactions to either subcutaneous or sublingual allergen immunotherapy.
In case of oral inflammation or wounds, such as following oral surgery or dental extraction, ORALAIR treatment should be discontinued to allow complete healing of the oral cavity. The risk of ORALAIR may be increased when treatment is initiated during the grass pollen season.
The most common adverse events reported in ≥5% of patients were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, and oropharyngeal pain. Patients who have escalating or persistent local reactions to ORALAIR should be reevaluated and considered for discontinuation of ORALAIR.
ORALAIR should be used during pregnancy or breastfeeding only if clearly needed.
Please see full Prescribing Information, including Boxed Warning and Medication Guide, for additional important safety information.
About STG320
STG320 is being studied for the treatment of house dust mite (HDM)-associated allergic rhinitis. More than 2400 patients have been enrolled in the rhinitis program consisting of adults, adolescents, and children (at least 5 years of age) with history of HDM-associated allergic rhinitis for at least 1 year and a specific sensitization to HDM allergens confirmed by clinically relevant symptoms, a positive cutaneous test for HDM allergies and/or a positive test for the specific IgE to HDM.
The results of the natural field and environmental exposure chamber studies demonstrate that the 500 IR and 300 IR doses of STG320 were similarly efficacious in treating adults with HDM-induced allergic rhinitis. In the natural field study which followed patients post-treatment, efficacy was maintained over a treatment-free follow-up year. Efficacy of both active doses in adolescents was demonstrated. A favorable safety and tolerability profile was observed for all tested doses. No deaths were reported. There were no reports of anaphylactic shock, anaphylaxis, or Intensive Care Unit admission and no use of epinephrine. The most frequent adverse events were application site reactions such as oral pruritus and throat irritation. Most were of mild or moderate severity and were reported during the first weeks of treatment. Treatment-related adverse events leading to premature discontinuation were more frequent with active treatment than placebo, and slightly more frequent with the 500 IR compared to 300 IR. The safety profile in children and adolescents was similar to that observed in adults.
In March 2015, following completion of a randomized, double-blind and placebo controlled study evaluating the efficacy and safety of a 12 month course of treatment with STG320 sublingual immunotheraapy tablets, the Japanese Pharmaceuticals and Medical Devices Agency approved STG320 as the first immunotherapy tablet for the treatment of HDM induced allergy in children and adults. Outside of Japan, STG320 is an investigational drug which has not been approved.
SOURCE: Stallergenes
Post Views: 230
