Spexis announces extension of moratorium, receipt of an additional payment related to the sale of a preclinical antibiotics program and reversion of the lonodelestat license from Santhera - Seite 3

About Lonodelestat

Lonodelestat is a highly potent and selective peptide inhibitor of human neutrophil elastase (hNE).  Neutrophil elastase is an enzyme associated with tissue inflammation, leading to degradation of the lung tissue in several acute and chronic pulmonary diseases.

In preclinical studies, lonodelestat was effective in animal models of neutrophil activation in lung tissue and of acute lung injury (ALI) [1, 2].  Currently available clinical data demonstrated that single and multiple doses (Phase 1b) of lonodelestat when administered by inhalation via an optimized eFlow nebulizer (PARI Pharma GmbH) can lead to high drug concentrations within the lung, resulting in inhibition of hNE in sputum of patients, an enzyme associated with lung tissue inflammation [3]. The Phase 1b study further confirmed the tolerability of lonodelestat after treatment of up to four weeks in patients with CF. Lonodelestat may also show therapeutic benefit for a range of neutrophilic pulmonary diseases with high medical need such as non-CF bronchiectasis (NCFB), alpha-1 antitrypsin deficiency (AATD), chronic obstructive pulmonary disease (COPD), acute respiratory distress syndrome (ARDS) or primary ciliary dyskinesia (PCD), amongst many others. 

Lonodelestat currently has EU orphan drug designations (ODD) for the treatment of CF as well as for AATD and PCD in both EU and US.
Both Spexis and Santhera acknowledges the support of the Cystic Fibrosis Foundation (CFF) by providing funding for the conduct of the Phase 1a and 1b safety trials with lonodelestat.

For further information please contact:

For Investors:  Stephen Jasper Managing Director Gilmartin Group [e-mail]

For Media: Dr. Stephan Feldhaus Feldhaus & Partner [phone] [e-mail]

Disclaimer

This press release contains forward-looking statements which are based on current assumptions and forecasts of Spexis management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development, in particular Spexis’ results, financial situation, and performance. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. Spexis disclaims any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.