One Step Closer to an Innovative Therapy for Sepsis
Not many people know how dangerous sepsis is. Even fewer people know that there is no specific therapy available to treat sepsis. Sepsis, a disorder that is developed from infections, can lead to limb amputations and deaths in a matter of days. For decades, it has remained one of the deadliest and costliest medical conditions. Now a startup is getting one step closer to finding an innovative therapy.
Finding an innovative approach
Aquaporin is a channel protein found in plants, animals, and humans. The discovery of aquaporin won Dr. Peter Agre a Nobel Prize in 2003. However, despite having a profound physiological impact, aquaporins have so far not been transformed into practical applications. Could aquaporins offer an innovative therapy for sepsis? Supertrends has been following the development of ApoGlyx, a start-up dedicated to creating aquaporin-based therapies. This year, ApoGlyx has seen promising achievements after more than a decade of hard work.
In April, ApoGlyx won the NLSInvest Rising Star Award on the first Nordic Life Science Investment Day. The award provided the opportunity for ApoGlyx to highlight its innovative therapy in front of investors.
Attracting new investors
For the last few years, ApoGlyx has been busy working on two preclinical studies with Professor Giuseppe Calamita of Bari University in Italy, Professor Angela Tesse Ragot, University of Nantes, and Prof. Christoph Thiemermann at the William Harvey Research Institute in London. Both studies have delivered promising results. “The results proved that a modulated aquaporin might offer a new approach for sepsis management,” Calamita told Supertrends in an interview. Thiemermann went one step further in describing the result as “striking”.
“We have never seen a drug that is administered after three hours after the onset of sepsis and is still effective.” – Professor Christoph Thiemermann, Director of the Centre for Translational Medicine and Therapeutics at the William Harvey Research Institute, and Supertrends expert
With sound scientific evidence to back up its claims, no wonder ApoGlyx stood out in the NLSInvest event. Following the event, Aploglyx successfully completed a US$700,000 (six million Swedish kronor) financing round. Among the new investors is the Swedish fund Almi Invest, a venture capital fund that supports early-stage start-ups with high growth potential and a scalable business plan.
Entering “Medicon Village”
To support its further development, ApoGlyx is entering the SmiLe incubator located in Medicon Village, in Lund, Sweden. Seated around the Öresund bridge between Sweden and Denmark in the thriving life-science region nick-named “Medicon Valley”, SmiLe is a prestigious life science incubator that has already produced 16 IPOs and demonstrated a success rate of 86 percent.
In its new home at SmiLe, ApoGlyx will further analyze valuable biomarkers with its already completed experiment and carry out further studies to provide more evidence for its aquaporin-based therapy.
“ApoGlyx is transforming from research into scaling and commercialization,” said Kristina Nyzell, an early investor who has witnessed the transformation of the start-up.
Contributing to sepsis awareness education
Sepsis, one of the earliest medical syndromes to be described in the history of medicine, remains one of the most dangerous and costly medical conditions even today. Nevertheless, public awareness of sepsis is poor across the globe. Surveys showed that only 7 to 50 percent of respondents were familiar with the term, including many who had an incorrect understanding of the condition.
To help the public understand sepsis better, ApoGlyx, in collaboration with Disruptiveplay, has developed a minicourse about what sepsis is, how to identify the condition, and how to manage it. The course is part of the Educate All initiative led by the United Nations Institute for Training and Research (unitar) and micro-learning platform EdApp. The Sepsis Awareness course can be accessed for free on EdApp.
Preparing for clinical trials
“Preclinical models that are often used for regulatory safety studies involve a rodent and a non-rodent species and must be relevant for the drug’s mode of action and expected off-target effects. Once sufficient safety information is obtained, dosage and treatment schedules are determined for Phase I trials in humans. I see no major obstacles for ApoGlyx’s next stage of clinical trials.” – Dr. Frank Staedtler, biologist, and Supertrends expert
Before the drug candidate is tested on humans, ApoGlyx must gain a better understanding of potential risks that their aquaporin-based therapy might have. The company will start a preclinical toxicology program in early 2022. After the toxicology data is analyzed, ApoGlyx will officially start its regulatory process for clinical trials.
The company plans to start its discussion with the European Medicine Agency (EMA) in 2022. If all goes well in Europe, ApoGlyx will then start the process in the US with the United States Food and Drug Administration (FDA).
It will certainly be a lengthy and uneasy journey to bring a new drug into clinical practice. The challenge will be even bigger when dealing with a condition like sepsis, which has previously defeated numerous attempts at therapeutic intervention. Today, factors such as emerging viral infections, antibiotic resistance crisis, and an aging population have caused sepsis to be an even bigger threat. More than ever, we need a successful therapy against sepsis. Aquaporin-based therapy provides an innovative approach to this challenge. Our report on Supertrends in Aquaporin and Sepsis describes how the future of aquaporin could be intertwined with the future management of sepsis.