Mediolanum licences Apeptico’s TNF peptide Solnatide

Solnatide, formerly AP-301, mimics the lectin-like domain of human tumour necrosis factor alpha and is designed to trigger alveolar liquid clearance through activation of the lung epithelial sodium ion channel ENaC.  Inhalation of the synthetic compound following lung transplantation improved gas exchange in the lungs and other lung function parameters of patients with primary graft dysfunction (PGD) during Phase IIa testing, cutting hospitalisation by up to 5 days.

According to Apeptico’s CEO Bernhard Fischer, “solnatide can reduce extravascular lung water index and improve lung function in trauma-induced pulmonary oedema, improve oxygenation and blunt reactive oxygen species production in vitro and in vivo. Safety and efficacy of orally-inhaled solnatide aerosol have been demonstrated in healthy volunteers, and in two interventional clinical studies in mechanically ventilated patients with acute respiratory distress syndrome ARDS and with PGD following lung transplantation.”

Under the agreement with Mediolanum, Apeptico will receive an an immediate up-front payment and funding of clinical development, Fischer told European Biotechnology. “The current overall rNVP value of the collaboration project is estimated to be around €60m.” Milestones are due to Phase III testing and EU market approval. The transfer price will be in the double digit million euro space. In return, Mediolanum will receive an exclusive license for solnatide for various European markets.

Cristina Del Bono, Licensing & Business Development Director of Mediolanum said: “We are proud to collaborate with Apeptico in their effort to bring to the market a new option for the treatment of patients affected with ARDS and PGD, two life-threatening conditions for which no satisfactory cure exists today. Beside in ARDS and PGD, Solnatide has also received orphan designation by the EMA in high altitude pulmonary edema (HAPE) and pseudohypoaldosteronism type 1b, two extremely severe conditions.”