New Asthma Treatment for Children: Activaero Reports Therapeutic Benefit and High Acceptance from Phase II Trial

New Asthma Treatment for Children: Activaero Reports Therapeutic Benefit and High Acceptance from Phase II Trial
Proof-of-concept study successfully completed in asthmatic children (age 3-11)
Significant reduction in dose and treatment time compared to standard therapy
High acceptance of treatment approach by patients and parents
Gemünden/Wohra, Germany, April 8, 2013 – Activaero GmbH, the therapeutic area specialist for respiratory diseases, today announced positive results from its phase II trial in children with mild to moderate asthma. The clinical study was conducted with Activaero's drug-device combination consisting of budesonide in liquid formulation and the Company's proprietary controlled inhalation system FAVORITE (Flow and Volume Controlled Inhalation Technology).

The proof-of-concept trial was designed to evaluate the applicability and potential superiority of Activaero's drug-device combination in comparison to liquid budesonide delivered with a conventional, general purpose nebulizer, in this case the PARI LC® Sprint. Not only did the Company's treatment enable pulmonary function benefit (FEV1), along with reduced inflammation (exhaled NO), but it also improved asthma control (C-ACT) and substantially reduced treatment times down to only two minutes, compared to 20 minutes with conventional nebulizer therapy. Such short treatment times are critical to successfully treat asthmatic children. As a result, Activaero's therapy was well accepted by patients and their parents. Moreover, the results also showed a trend towards superior efficacy and excellent safety, in particular with respect to pharyngeal side effects. However, this was to be expected because of the unparalleled performance of Activaero's aerosol system.

In summary, the phase II trial showed that Activaero's therapy approach, i.e. combining budesonide suspension with the Company's proprietary FAVORITE inhalation system, is effective in the treatment of mild to moderate asthma in children and holds the promise to become the preferred treatment option when compared to conventional, general purpose therapy.

The clinical proof-of-concept study was designed as an open-label, randomized, observational, two-arm, multicenter pilot trial, conducted with 41 children in Germany, age 3 to 11 years, with mild to moderate asthma. Patients were treated twice daily over 12 weeks with budesonide suspension [0.5mg/mL concentration] administered via Activaero's inhalation system that uses the Company's proprietary FAVORITE approach. The actual budesonide dose applied with the FAVORITE was reduced by 75% in comparison to the conventional JET nebulizer (i.e. PARI LC Sprint), as the deposition of the active drug into the lungs with Activaero´s approach is much more efficient. 

Gerhard Scheuch, Founder and Chief Executive Officer of Activaero GmbH, explained: "We are excited about the potential of this drug-device combination to improve the treatment of children's asthma. Usually a relatively long treatment time of 20 minutes is required in asthma therapy of young children while the therapeutic effects are often unsatisfactory. That is a problem, especially in this patient population, who are often not able to stay focused during the inhalation process. Our therapy approach has shown that with only 25% of the usual dose the drug deposition into the lung is higher, while, at the same time, treatment duration was significantly reduced to only 2 minutes. These promising results promote the further development of Activaero´s inhalation approach tailored to the special needs of children suffering from asthma."

Based on the encouraging data from the phase II trial, Activaero also plans to further modify the inhalation system for optimal pediatric use.

About Asthma
Asthma is a chronic disease caused by inflammation of the airways that leads to bronchial obstruction. It occurs in all age groups, but often starts in childhood. Symptoms of asthma are recurrent attacks of breathlessness and wheezing, also known as asthma exacerbations. Severity and frequency of exacerbations vary from patient to patient. The degree of severity is characterized by frequency and intensity of recurring asthma attacks despite medical treatment.

About Safe Corticosteroid Inhalation in Pediatrics, SCIPE
Current guidelines from the Global Initiative for Asthma (GINA) state, that inhaled therapy is the cornerstone of asthma treatment in children, since almost all children can be taught to use inhaled therapies effectively. Although the impact of the inhaler devices on drug delivery and a drug's lung deposition is well known, it is seldom taken into account when inhaled therapy is prescribed to treat children's asthma. This leads to poor efficacy and therapy adherence, due to the child's or its caregiver's inability to correctly use the inhalation device and inadequate lung deposition of the prescribed medication. Inhaled corticosteroids play an important role when treating asthma in children. In order for these drugs to create the best therapeutic effect, regular use and sufficiently high, consistent and homogenous lung deposition is required. On the other hand, low oropharyngeal (i.e. throat) deposition of the drug is essential to avoid unwanted side effects. With Activaero's FAVORITE inhalation approach, all these criteria can be met, leading to a more child-friendly therapy and improved disease and symptom control.

FAVORITE is Activaero's proprietary, clinically and commercially proven inhalation approach to effectively treat severe respiratory diseases. FAVORITE actively regulates inspiration flow and inhalation volume. By guiding, controlling and supporting the patient's breathing, optimal inhalation patterns are created.

Using FAVORITE, a respiratory therapy can be selectively targeted to pre-defined lung regions hence unlocking completely new opportunities for novel aerosol therapies.

About Activaero
Activaero is a therapeutic area specialist developing treatment solutions for patients suffering from severe respiratory diseases, including Asthma, Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis (CF), Idiopathic Pulmonary Fibrosis (IPF) and Pulmonary Hypertension. Activaero´s clinically proven treatment approach FAVORITE ensures highly efficient, targeted and safe local drug deposition in the lungs to fight severe respiratory diseases with dramatically better therapeutic outcomes. Activaero was founded in 1998 in Germany and is a privately held company with offices near Frankfurt and Munich in Germany as well as in Dublin, Ohio (USA).

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