APEPTICO agrees supplying its development compound SOLNATIDE

APEPTICO Forschung & Entwicklung Mariahilferstraße 136, Top 1.15 1150 Vienna, Austria Phone: +43-664-1432919 Fax: +43-1-25330337795 URL: www.apeptico.com PRESS RELEASE APEPTICO agrees supplying its development compound SOLNATIDE for the immediate treatment of COVID-19 patients Vienna, Austria, 12 th March, 2020: APEPTICO Forschung und Entwicklung GmbH today a n n o u n c e d t h a t i t h a s b e e n i n v i t e d t o g e t h e r w i t h i t s c o n s o r t i u m by the European Commission through the Horizon 2020 research and innovation programme to s tart the grant preparation to make APEPTICO’s proprietary inve stigational medicinal product ( IMP) solnatide available for medical treatment of patients severely affected by novel corona virus 2019 (2019-nCoV) disease, COVID-19. APEPTICO is a privately-held b iotechnology company based in Aus tria, developing peptide-based medicinal products to treat life- threatening pulmonary dysfunct ions, such as severe respiratory failure, oedematous respiratory failure (lung oedema), acute respiratory distress syndrome (ARDS), primary graft dysfunction (PGD) following lung transplantation, high al titude pulmonary oedema (HAPE) and pseudohypoaldosteronism type 1B (PHA1B). APEPTICO’s lead compound, the therapeutic molecule solnatide (INN) is being developed by APEPTICO for the treatment of various forms of life-threatening acute pulmonary dysfunction and pulmonary oedema in ARDS patients. In 2013, APEPTICO successful l y c o m p l e t e d a p h a s e I c l i n i c a l study in healthy subjects, proving the safety of solnatide. APEPTICO subsequently successfully completed two phase II clinical studies, one a randomized, double-blinded placebo-controlled trial using inhaled solnatide in mechanically-ventilated ARDS patients with lung oedema, the other a randomized, double-blinded placebo-controlled trial study in patients suffering from primary graft dysfunction (PGD) following lung transplantation. Clinical data gathered so far from hospitalised patients suffer ing from COVID-19 have revealed that 20% suffer from ARDS and the involvement of pulmonary oedema is evidenced by post-mortem sampling of a patient who succumb ed to COVID-19 infection. The known mortality rate for ARDS is 20-30%. At present no medicine has been approved specifically f or the therapeutic treatment of pulmonary permeability oedema or ARDS. Within the scope of the Horizon2020 “Advancing knowledge for th e clinical and public health response to the 2019-nCoV epidemic” ( https://ec.europa.eu/commission/presscorner/detail/en/ip_20_386) APEPTICO’s program proposal was ranked among the top applicants. According to the objective of the call, APEPTICO will use its capacity and expertise to immediate ly explore the efficacy of solnatide IMP as a therapy for COVID-19. Furthermore, in this emergency situ ation in hospitals across Europe, APEPTICO will make solnatide IMP available for the acute and therapeutic treatment of patie nts suffering from severe symptoms of infection with the 2019-nCoV novel coronavirus. Commenting on the EU Grant invitation, Bernhard Fischer, CEO of APEPTICO, stated: "We are very happy that the European Commission has recognised the clinical potential of solnatide for the treatment of severely affected patients with the new coronavirus. By offering our solnatide IMP for the immediate treatment of patients, APEPTICO commits its responsibilities towards the society.” - - ENDS - - About APEPTICO APEPTICO Forschung und Entwicklung GmbH (“APEPTICO”) is a priva tely-held development stage biotechnology company with office in Vienna, Austria, developing peptide-based products targeting life- threatening pulmonary diseases, including oedematous respirator y failure, acute lung injury, primary graft dysfunction, high altitude pulmonary oedema and PHA type 1. The peptide molecules correspond to validated, pharmacodynamic ac tive structures and domains of proteins and biopharmaceuticals. By concentrating on synthetically produced protein structures APEP TICO avoids general risks associated with gene- and cell-technologies. APEPTICO makes use of its tec hnology platforms PEPBASE(TM) and PEPSCREEN(TM) to significantly reduce cost and to shorten time to market. About solnatide Solnatide (laboratory code AP301) is a synthetic molecule whose structure is based on the lectin-like domain of human Tumour Necrosis Factor alpha. Solnatide is water soluble and can be administered as aerosol (small droplets of diameter 3 μm or less) directly into the lung of patients by oral inhalation. Solnatide IMP has been designed for activation of the pulmonary epithelial sodium channel (ENaC) and for the restoration of the injured endothelial-epithelia barrier of pulmonary alveoli. APEPTICO’s investigational compound solnatide (INN) was originally designed for the therapeutic treatment of patients with Acute Respiratory Distress Syndrome (ARDS) and various forms of life- threatening pulmonary permeability oedema (PPO). Orally inhaled Solnatide IMP has completed a first- in-man (FIM) Phase I clinical study (EUDRACT No. 2011-000223-33), and has delivered clinical proof- of-concept in two randomised, placebo-controlled, double-blinded Phase II clinical studies (EUDRACT No. 2012-001863-64; EUDRACT No. 2013-000716-21) in patients suf fering from pneumonia, sepsis, ARDS, Primary Graft Dysfunction, and other causes of life-threatening pulmonary dysfunction. Solnatide IMP has been designated as orphan medicinal product in the European Union for the therapeutic indication “Treatment of Acute Lung Injury (ARDS)”. About the consortium For the European Horizon2020 project, APEPTICO has formed a con sortium of leading European companies from Germany, Italy, and the Netherland, to continue and speed up the manufacturing process of solnatide, as well as the immediate employment of solnatide IMP for clinical use. Contact Prof. Dr. Bernhard Fischer, CEO APEPTICO Forschung und Entwicklung GmbH Mariahilferstraße 136, Top 1.1.5 1150 Vienna, Austria T: +43-664-1432919 F: +43-1-25330337795 E-mail: [email protected] URL: www.apeptico.com

The release as fetched from its publisher. apeptico.com ↗