LASAG INHALE^©

AspiAir in Germany is a clinical-stage biotech company focusing on the development of safe and comfortable non-opioid treatments for pain and migraine attacks. Members of the former clinical and project management team of Vectura founded the privately financed startup in 2019. AspiAir has its main operations near Marburg and is backed by the family office ATON GmbH in Munich. AspiAir holds several formulation and device patents to protect the therapeutic approach.

The most advanced program is an inhaled version of LASAG (Acetylsalicylic Acid – ASA). It is the first non-invasive, mobile LASAG treatment – at home or on the road.

Just breathe! We transfer a well-known and safe i.v. therapy to the Patients’ Home.

We develop  LASAG Inhale©, a first a first inhaled treatment for different types of pain. It is expected to have the advantages of Aspirin® i.v. (efficacy, safety and quick response), but can be applied by the patients themselves – at home and on the road.

More than 37 million people in the EU suffer from pain and migraine attacks, a considerable part of which have no access to adequate and effective medication. Today’s standard treatments are either costly or associated with side effects. Thus, many patients will benefit from a simple, inhaled treatment with a well-established drug.

Triptanes, the standard medication for migraine, have limited applicability and are not well tolerated by some patients; and novel antibody therapies (such as CGRP antagonists) are expensive (appr. US$ 800 per treatment).

Acetylsalicylic acid (ASA): an effective and well-known treatment since decades

Migraine is a common disabling primary headache disorder. Epidemiological studies document its high prevalence and socio-economic impacts. In the Global Burden of Disease Study 2015, it was ranked the third-highest cause of disability. Some patients suffer from frequent migraines, up to several times a week, others only occasionally.

Acetylsalicylic acid (ASA) has been an effective and well-known treatment for acute migraine since years. Current labeling includes oral doses of ASA of up to 1000 mg for the treatment of acute attacks, the intravenous formulation is approved for injection for infusion of up to 1000 mg. The inhibition of COX-1 by ASA accounts for its inhibition of platelet aggregation, at the same time is also associated with adverse effects on the gastrointestinal tract when taken orally.

Applying drugs via inhalation is a usual and recommended procedure as the lung is an organ with high blood perfusion and an ideal entry point, and there is broad experience with inhaled ASA and its rapid bioavailability.

Diener HC et al. Efficacy and safety of intravenous acetylsalicylic acid lysinate compared to subcutaneous sumatriptan and parenteral placebo in the acute treatment of migraine. Cephalgia (1999) 19:581-8

At home or on the road!

Together with pulmonary drug delivery specialist Activoris, a high-performance mobile, battery-driven inhaler is being developed, allowing to nebulize high drug concentrations for deep lung deposition, thus keeping treatment times down. Further, a special and comfortable reconstitution and transfer system is under development, allowing a one-handed mixing and transfer of LASAG solution into the inhaler, making drug loading and inhaling a child’s play.

Clinical Data: Phase 1 PK-Study Results

The current study was a Phase 1 three dose level cross-over study, split in two parts. In the first part, single dose inhalations of LASAG were evaluated for PK/PD as well as safety and tolerability in 16 healthy subjects compared to i.v. LASAG in a cross-over design. In the second part, a single inhaled dose with a higher concentration of ASA/ml was evaluated in 12 healthy subjects.

As expected, a lower rate and extent of exposure with ASA was reached after inhaled administration of LASAG compared to intravenous administration. A clear and strong reduction in thromboxane B₂ (TxB₂₎ plasma concentration was seen for inhalation, comparable to intravenous treatment. TxB₂ can serve as a surrogate marker for efficacy, because COX enzymes are involved in the production of thromboxanes and are responsible for the production of prostaglandins (key mediators in inflammation and pain responses). Inhalation was well-tolerated.