Apeptico gets EU grant for COVID-19 drug

According to the Viennese company, 20% of hospitalised patients with COVID-19 suffer from acute respiratory distress syndrome (ARDS), a potentially life-threatening complication of infection with SARS-CoV-2. Official numbers indicate that about 6% of all infected patients are in critical stage an must be advised to a critical care unit (ICU) for the management of sepsis-like disease symptoms in ARDS patients. 

APEPTICO Forschung und Entwicklung GmbH, as part of the EU-funded solnatide consortium, will accelerate clinical development of APEPTICO’s proprietary cyclic peptide solnatide to treat late-stage COVID-19 patients in order to prevent bad outcomes. The company’s Phase II lead compound, solnatide (AP-301) is currently being developed for the treatment of various forms of life-threatening acute pulmonary dysfunction and pulmonary oedema in ARDS patients.

Solnatide (laboratory code AP301) is a synthetic peptide of less than 20 amino acids. Application of solnatide directly into the lower respiratory tract, in form of a liquid aerosol, is expected to activate the pulmonary sodium ion channels (ENaC) to directly activate alveolar liquid clearance and to reduce the leakage of blood and fluids from the capillaries in the air-space, i.e. accelerate the resolution of alveolar oedema and reduce barrier injury in the lung. In addition to its alveolar liquid clearance activity, solnatide inhibits hypoxia-induced reactive oxygen species (ROS) production and counter-acts various ROS and toxin-mediated effects frequently observed in pneumonia: Solnatide inhibits PKC-alpha activation thereby restoring ENaC activity. Solnatide reduces the degree of myosin light chain (MLC) phosphorylation and thus protects and restores the barrier integrity of endothelial and epithelial cells. Solnatide lacks pro-inflammatory activity and does not lead to an increased production of chemokines or an increased infiltration of neutrophils.

Inhaled solnatide has passed Phase I safety testing and two Phase II trials, one in mechanically-ventilated ARDS patients with lung oedema, the other a randomized, placebo-controlled pilot study in patients suffering from primary graft dysfunction (PGD) following lung transplantation. According to the company, currently no medicine has been approved specifically for the therapeutic treatment of pulmonary permeability oedema or ARDS.

Commenting on the EU Grant Agreement, Bernhard Fischer, CEO of APEPTICO, stated: "We are very happy that the European Commission agreed with APEPTICO and the “solnatide-consortium” to financially support us in the consortium’s effort to make solnatide IMP available for the treatment of severely affected patients with the new coronavirus.”