Medical researchers in the State of Georgia believe they have locked in on a game-changing treatment for at least severe cases of COVID-19 involving acute respiratory distress syndrome (ARDS) and pulmonary edema. The Augusta University (AU) Medical College of Georgia (MCG) investigators include Dr. Joyce Gonzales, a Pulmonologist in the pulmonary critical care department and her mentor, and Dr. Rudolf Lucas, a Vascular Biologist with MCG. What is that game changer? Solnatide—as it has already been approved in Austria for compassionate use for COVID-19 cases with severe ARDS and pulmonary edema. Many years ago, Dr. Lucas worked on the discovery teams involved with what would become the drug. Now owned by an Austrian biotech venture called Apeptico Forschung und Entwicklung (Apeptico), TrialSite News not long ago profiled the company and the drug; we provide an update here.
What is Solnatide?
Solnatide is a peptide-based therapy currently being used in clinical trials as a treatment for acute lung injury. 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.
By 2013, the company successfully completed a Phase I clinical study in healthy subjects, evidencing the safety of the drug. The Austrian company subsequently completed two Phase II clinical trials including one randomized, double-blinded placebo-controlled trial using inhaled Solnatide in mechanically-ventilated ARDS patients with lung edema and the other study a randomized, placebo-controlled pilot study in patients suffering from graft dysfunction (PGD) following lung transplantation.
Clinical data gathered thus far from hospitalized patients suffering from COVID-19 have revealed that 20% suffer from life-threatening pulmonary dysfunctions, such as acute respiratory distress syndrome (ARDS), and the involvement of pulmonary edema is evidenced by post-mortem sampling of patients who succumbed to the novel coronavirus infection.
Forthcoming Clinical Trials
Studies targeting COVID-19 have commenced in Austria and they will be expanded to eight sites across Europe. The hope is that the trials will make it across the Atlantic to the United States. One target for America is Grady Hospital at Emory. Once Solnatide can commence here, according to the NBC article, the study would be lead by Dr. Shaheen Islam—Gonzales would serve as a coordinator at MCG. Dr. Lucas sincerely hopes the results from the European clinical trials will be back by the end of 2020. He knows that the drug’s developer will request for funding for a study in America as well.
Apeptico Forschung und Entwicklung (Apeptico)
Profiled by TrialSite News on April 9, the drug is being developed by an Austrian biotech company called Apeptico Forschung und Entwicklung (Apeptico). Their lead compound, Solnatide, has been approved for compassionate use for COVID-19 patients with ARDS or pulmonary edema. They are developing Solnatide for the treatment of various forms of life-threatening acute pulmonary dysfunction and pulmonary edema in ARDS patients.
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. 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.
The Research Sites in America
Medical College of Georgia is the medical school for Augusta University. It is the flagship medical school of the University System of Georgia, the state’s only public medical school, and one of the top 10 largest medical schools in the United States. Established in 1828 as the Medical Academy of Georgia, MCG is the oldest and founding school of Augusta University. The third-oldest medical school in the Southeast and the 13th oldest in the nation, they maintain 22 departments and offer both a Doctor of Medicine (MD) program as well as a MD-PhD, MD-MPH, and MD-MBA degrees. Its national ranking in research is 84th.
Call to Action: The Austrian firm Apeptico Forschung und Entwicklung is seeking investor partners. They can be contacted here.