Israeli clinical-stage bio-pharmaceutical company PolyPid has created an exciting new technology that enables the controlled and continuous delivery of drugs to surgical sites.
Surgical site infections (SSIs) – which occur within 30 days of surgery – are the second most prevalent type of healthcare acquired infections after urinary tract infections.
They threaten the lives of millions of surgical patients every year and their treatment can contribute to the spread of antibiotic resistance.
In Europe, SSIs affect more than 500,000 people per year costing the healthcare sector up to €19 billion, according to the World Health Organization.
Meanwhile, in low- and middle-income countries the risk is three to five times higher – more than one in ten people who have surgery will get an SSI.
That’s where PolyPid comes in. The Israeli clinical-stage bio-pharmaceutical company is striving to reduce overall SSI rates, including infections due to antibiotic-resistant bacteria.
Its strategy has two elements – development of its product pipeline, and collaborations with pharmaceutical companies to improve the local delivery of their medications.
PolyPid’s PLEX (Polymer-Lipid Encapsulation matriX) technology is a unique product that is anchored in the surgical site to provide controlled and continuous delivery of medications.
Surgeons deliver the medicine locally and the technology enables it to be released slowly over days or months.
This improves patient outcomes in various localised medical conditions such as infection, pain, inflammation and cancer.
It also means that the drug dose can be just a small fraction of the traditional administrated systemic doses which are diluted through the bloodstream.
Dikla Czaczkes Akselbrad, CEO at PolyPid, described the technology to Health Tech World as “revolutionary”.
“If you can put the drug, the chemotherapy, the anti-pain, the anti-inflammatory, the anti-infection at the site, you can enhance the concentration, you can enhance the efficacy, and reduce dramatically the toxicity and the side effects,” she said.
How it works
PLEX platform is a matrix made of thousands of alternating layers of polymers and lipids that entrap a therapeutic drug.
This self-assembled matrix forms a protected reservoir. Gradual disintegration of the layers over days to several months sees the drug delivered to the site in a controlled way.
The bio technology overcomes systemic penetration challenges encountered in various locations in the body – such as in organs with limited blood supply.
There are numerous advantages to PLEX.
It can accommodate many types of drug as well as product compounds with sensitivity to heat, pH and enzymes.
The medicine can be delivered by itself or in conjunction with other products – and can be inserted during surgery as a paste, an injectable formulation or as the coating of a medical device.
“The innovation of what we bring is that if you administer the drug locally, you can create a much higher local concentration without the systemic exposure,” Akselbrad explained.
“There is no influence on the microbiome. None whatsoever. And very little, if at all, systemic exposure.”
The technology protects the drug from hydration and degradation and provides for predetermined drug release parameters.
PLEX is composed of well-known components which are commercially available and extensively used in the pharmaceutical industry.
Production is performed under cost effective conditions – no covalent bonds are created during the self-assembly.
And finally, no specialised training is required for surgeons – the technology is highly intuitive to use.
PolyPid is fully focused on the entire process of developing, manufacturing and commercialising its novel, locally administered therapies.
It has paired its PLEX technology with drugs already approved by the US Food and Drug Administration or innovative drug candidates.
The company is now in the process of evaluating the safety and effectiveness of the medical product in clinical trials.
It will then submit the trial results to regulatory agencies, before being given legal approval for use.
D-PLEX100, designed for prevention of SSI in abdominal soft tissue and sternum bone tissue following surgery is moving quickly through its trial phases, and is now at phase three.
Previous studies have shown a significant decrease in infections and mortality at the 30-day endpoint, by close to 60 and 70 percent respectively.
This product has the potential to dramatically cut global costs associated with SSIs as well as protect patients against antibiotic-resistant bacteria, Akselbrad stressed.
Meanwhile, OncoPLEX for intratumoral therapy is at the preclinical stage. This targets solid tumours with chemotherapeutic drugs which are released for three weeks at the tumour site.
“Again, minimum to no systemic exposure, reduced side effects – very nice results.”
Health tech in Israel
The Israeli health tech industry currently includes more than 250 new start-ups and is rapidly growing.
“We have a unique industry here, with a lot of innovation,” Akselbrad told Health Tech World. “There is an ecosystem that educates and builds professionalism and knowledge.”
But the focus is on medical devices and not so much on pharmaceutical biotechnology, she explained.
That’s ultimately down to the nature of biology – the longer timelines from conception to selling the product, which can often take up to ten years, and the larger costs.
“You need a lot of tries until you actually have a successful drug at the market,” Akselbrad said, “and that’s where companies fail.”
However, the chief financial officer, who has been board nominated as the company’s next chief executive officer starting July 1, sees a bright future for the local sector.
“I think this is relatively still a young industry in Israel, there is a lot of room to grow.”
Akselbrad hopes that more biotech start-ups will be given the funding and support to complete the entire process from idea to commercialisation.
“I think this is really what is missing. A lot of companies have a great idea, great execution, but they’re bought early on, or the product is licenced very early on.
“I hope that there will be more companies that have a similar strategy to us, to become a fully integrated biopharmaceutical company.
“We have the research stage, the development stage, the clinical stage, the regulatory, we built our own manufacturing facility, and now we are building the infrastructure for the commercial states.”
And that all comes from the ability to finance the process through a supportive investment community, Akselbrad said, adding that “as we see more and more success coming out of here, the money will follow”.
As a finance expert with more than 20 years’ experience, the CFO said she is proud to be able to ensure that PolyPid fully maintains its asset and stays independent for many years.
This is an excerpt from our Special Feature – Israel: Health Tech Powerhouse
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