Austrian Biotech’s Investigational Phase II Drug Receives Compassionate Use Approval for COVID-19 ARDS

Apr 9, 2020 | Acute Respiratory Distress Syndrome, ARDS, Austria, Coronavirus, COVID-19, EU, Investor Watch, News, Pulmonary Edema

Austrian Biotech’s Investigational Phase II Drug Receives Compassionate Use Approval for COVID-19 ARDS

About 20% of those hospitalized with COVID-19 suffer from acute respiratory distress syndrome (ARDS), a potentially life-threatening complication of the infection with SARS-CoV-2. Consequently, an Austrian biotech has received compassionate use approval from the Austrian Federal Office for Safety in Health Care for its lead drug candidate Solnatide for the treatment of the COVID-19 patient population. Specifically developed by Apeptico Forschung und Entwicklung GmbH, this Phase II drug candidate has received approval for the treatment of acute respiratory distress syndrome (ARDS) and pulmonary edema. The company is ultimately seeking corporate development partnerships.

COVID-19 Concern: Upper Respiratory Infections

As COVID-19 patient’s conditions worsen, based on the World Health Organization (WHO) disease stages, the danger of ARDS or pulmonary edema becomes more imminent. In a well-known study in Wuhan, China, of the 54 people that died due to COVID-19, 50 actually died because of ARDS. In a horrific scenario, as ARDS sets in and worsens, patients are placed on ventilators and it has been reported its as if a person is drowning. 

The Drug

Developed by the small Austrian company called Apeptico Forschung und Entwicklung GmbH, Solnatide has been approved for compassionate use for COVID-19 patients with ARDS or pulmonary edema. The Phase II drug candidate can potentially help up to 20% of hospitalized patients who develop life-threatening pulmonary disorders, such as ARDS and to counteract the formation of pulmonary edema. According to European Biotechnology, the drug (also known as AP301) is a synthetic peptide of less than 20 amino acids. It is applied directly to the lower airways of the lung via a liquid aerosol; this activates the pulmonary sodium ion channels (ENaC) to activate alveolar fluid clearance and reduce the leakage of blood and fluids from the capillaries in the air space.

The drug also inhibits the production of hypoxia-induced reactive oxygen species (ROS) and counteracts various ROS and toxin-mediated effects typically alongside pneumonia. The investigational, Phase II drug inhibits PKC-alpha activation and hence, restores ENaC activity while reducing levels of myosin light chain phosphorylation (MLC)—as reported in European Biotechnology, Solnatide protects and restores the barrier integrity of endothelial and epithelial cells. It has no inflammatory activity and according to the drug’s maker, doesn’t produce chemokines or increased infiltration of neutrophils.

Closing a Gap in Care?

According to the Austrian biotech company, the Compassionate Use approval of Solnatide closes an important gap in care as there is no drug approved specifically for the therapeutic treatment of ARDS or pulmonary permeability edema in COVID-19 patients. Importantly, drugs cannot be sold nor reimbursed under Compassionate Use scenarios, reports Bernhard Fischer, Managing Director of the Vienna-based venture.

Drug Costs Backed by ‘Horizon 2020’Funding

The European Union has funded a “Solnatide consortium” to accelerate clinical development of Apeptico Forschung’s proprietary cyclic peptide to treat late-state COVID-19 patients in order to prevent deadly outcomes. This Phase II drug was identified as it is currently in development for the treatment of various forms of life-threatening acute pulmonary dysfunction and pulmonary edema in ARDS patients. With this declaration and associated consortium, the company receives financial support to make the drug available for severely affected patients due to COVID-19.

What is Horizon 2020?

Horizon 2020 is the biggest EU Research and Innovation program in history with nearly 80 billion euros of funding available over a seven-year period (2014 to 2020). Additionally, the fund was set up to attract private capital markets into life sciences and other research endeavors. The EU’s goal was to spur ever greater numbers of breakthroughs, discoveries, and new products ultimately from lab to market.

The Company

A privately-held biotechnology company in Austria, Apeptico Forschung und Entwicklung GmbH, develops products targeting chronic and life-threatening diseases. The peptide molecules correspond to validated pharmacodynamic active structures and domains of well-known proteins and biopharmaceuticals. The company touts its risk mitigation strategy by avoiding gene and cell technologies and rather, by focusing on synthetically produced protein structures. The company leadership includes expertise and experience from pharma and academic research.

Founded in 2009, the company has secured $4 million in equity investment from BioScience Ventures Group, according to Crunchbase. A boutique investor of small life science companies, the Munich-based venture capital group, BioScience Ventures Group is led by a surgeon and PhD researcher.

Investor Watch

The company is seeking corporate partners to license and distribute the drug elsewhere and potentially investors.

Call to Action: Solnatide has received Compassionate Use approval in Austria and some funding support from the European Union. If the experimental Phase II drug actually helps reduce ARDS in severe COVID-19 cases, then there could be potential here because, according to some studies, upper respiratory ailments are associated with mortality rates of COVID-19. The Austrian company is seeking partners, and this could be an investment opportunity depending on, of course, many underlying details. The company can be contacted here. Their CEO is Dr. Bernhard Fischer

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