LASAG trial for severe influenza initiated

Activaero GmbH, the therapeutic area specialist for respiratory diseases, today announced that the first patients have been enrolled in an international proof of concept trial to treat hospitalized patients with acute severe, potentially life-threatening influenza. This multi-center, randomized, double-blind, placebo-controlled trial will evaluate the safety and efficacy of LASAG (lysine acetylsalicylate glycine), inhaled three times daily, in comparison to standard therapy; optionally including oseltamivir (Tamiflu®). LASAG is an antiviral drug, which potentially slows down the replication of the influenza virus.

The primary endpoint of the trial is the "time to alleviation" of clinical signs of acute influenza, i.e. headache, aches, feverishness, fatigue, cough, sore throat and nasal congestion. Secondary endpoints include vital signs, avoidance of intubation and duration of hospitalization.

"This trial is highly relevant for physicians and patients. It will be a major breakthrough in the field of influenza therapy if we can prove that the mechanism of action of LASAG, directly delivered to the lungs using Activaero's FAVORITE approach, allows us to treat patients already confirmed with severe influenza," commented Gerhard Scheuch, Founder and Chief Executive Officer of Activaero GmbH. "

The trial is expected to enroll 175 patients who will be randomized to one of three treatment groups. Each patient will receive five days of treatment with either inhaled LASAG (high or low dose) or LASAG placebo inhalation. The trial will be conducted in 50 centers throughout Europe and South America.

About Severe Influenza

Influenza is an acute viral infection that spreads easily from person to person and circulates worldwide. Influenza is characterized by a sudden onset of high fever, cough (usually dry), headache, muscle and joint pain, severe malaise (feeling unwell), sore throat and runny nose. Influenza can affect anybody in any age group and is a serious public health problem that causes severe illness or death in people at high risk: children younger than age two years, adults age 65 years or older, and people of any age with certain medical conditions, such as chronic heart, lung, kidney, liver, blood or metabolic diseases (such as diabetes), or weakened immune systems. The standard therapy to treat the illness is oseltamivir, while this therapy is not efficacious in severe hospitalized patients. Influenza can cause serious public health and economic problems. While most people recover from a bout of influenza, there are large numbers of people who need hospital treatment and die from the disease every year.

About Activaero's influenza treatment with LASAG

Activaero's influenza program addresses the high unmet medical need to treat severe influenza. Activaero's program combines LASAG with Activaero's proprietary FAVORITE inhalation approach. LASAG is a pain-relieving, fever-reducing and anti-inflammatory substance (non-steroidal anti-inflammatory/analgesics). The active ingredient in LASAG is D,L-Lysinacetylsalicylat Glycin, a water soluble form of acetylsalicylic acid. LASAG is used to treat acute moderate to severe aches and migraine and fever. As opposed to currently available antiviral therapies, inhaled LASAG has a direct inhibiting effect on the replication of the virus and thus leads to an effective reduction of the virus load. In order to obtain this effect the drug has to be delivered into the lungs.

About FAVORITE

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. These then match the therapeutic requirements for severe respiratory diseases and patients' physical conditions. Using FAVORITE, a therapy can be selectively targeted to pre-defined lung regions and unlock 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 drug deposition in the lungs to fight in particular 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.