Serendex Pharmaceuticals A/S : First patient dosed in Serendex’s pivotal trial for PAP

Serendex's phase II/III clinical trial of lead drug candidate Molgradex® for patients with pulmonary alveolar proteinosis (PAP) has included its first patient.

The patient has been dosed with Serendex's proprietary, nebulized formulation of recombinant human GM-CSF Molgradex®, or placebo and is the first out of up to 51 patients to be recruited to the trial during a period of estimated one year. Top line data from the treatment period is expected 1H 2018.

'Already published data show that inhalation of molgramostim has beneficial effect in PAP patients. We hope that the trial demonstrates positive effect in oxygenation of the lungs. If so, the quality of life for these patients is likely to increase significantly', says Serendex CEO, Kim Arvid Nielsen.

Primary aim of the trial which has been named IMPALA is to confirm the efficacy and safety of Molgradex® in PAP patients. IMPALA is a randomized, double-blind, placebo-controlled multicentre trial lead by Coordinating Principal Investigator Dr. Cliff Morgan from the Royal Brompton Hospital in London, United Kingdom.

A total of 15 sites in Europe (including Russia and Israel) and Japan have been selected for the IMPALA trial.

Serendex is currently also developing Molgradex® for the treatment of acute respiratory distress syndrome in a phase IIb clinical trial in Germany.

Download press release 240516 First patient dosed in Serendex pivotal trial for PAP

For further information, please contact :

Kim Arvid Nielsen
CEO
Mobile [phone]
E-mail: [e-mail]

or,

Nadia Vega Vasiljev
Head of communication and IR
Mobile [phone]
E-mail: [e-mail]

About Serendex Pharmaceuticals A/S

Serendex Pharmaceuticals develops drugs to treat severe respiratory conditions such as PAP (pulmonary alveolar proteinosis) and ARDS (acute respiratory distress syndrome). These conditions are acute or chronic and have no existing medical treatment. All Serendex drugs are inhaled or induced to the lungs of the patient. This improves the risk/efficacy ratio of the drug and treatment. Serendex has obtained orphan drug designation (ODD) for several indications in both Europe and USA. The company's sole business focus is drug repositioning, i.e. finding new indications and administration routes for existing drugs. Please visitwww.serendex.com to learn more.