Surgical site infections (SSIs) are the second most prevalent type of healthcare acquired infection, having a significant negative impact on patients and healthcare systems. SSIs represent a $10 billion healthcare problem in the United States. PolyPid, a late-stage biopharma company, is aiming to help improve surgical outcomes by tackling infections in the OR.
DocWire News sat down with Dr. Noam Emanuel, co-founder and Chief Scientific Officer of PolyPid, who discussed the steps the company is taking to bring infection control into the 21st century with promising innovations that can improve the standard of care.
DocWire News: Can you provide us with background on yourself and the company, PolyPid?
Dr. Noam Emanuel: First of all about myself, my background is PhD from the Hebrew University in Jerusalem, the Faculty of Medicine. And I accomplished that in 1996, about 25 years ago. And during the studies I develop actually drug delivery systems, liposome, targeted liposomes. Although I serve in different biotech companies and I am the expert in diagnostic vaccines, local and systemically have delivery of drugs and also immunotherapy. In 2008, actually I was the Co-Founder of PolyPid. I was the first CEO of PolyPid over the first two years. Over the last 10 years, I am the Chief Scientific Officer in PolyPid. So, that’s about myself.
About PolyPid, PolyPid is a late-stage biopharma company. And we are aiming to dramatically improve surgical outcomes, that’s the most important, by local delivery. Actually the slogan of PolyPid is, “Go local.” And that’s the mission, to go local within drugs to solve unsolved issues in surgeries. What is our target today is mainly surgical site infections occurring in OR, in operational room. That’s the main mission we’re dealing with. We believe that’s a huge target and a very important one in terms of economic and also to humanity. PolyPid is located in Israel, and our office in Petach Tikva in Tel Aviv. We have other offices also in New Jersey, in the US. We have our own GMP facilities, also located in Israel. So, we are well occupied to solve the issue. We are now in three Phase III clinical studies with our lead product, D-PLEX. With that, we gain from the FDA also the breakthrough designation, also fast track designations for prevention of infection, SSI.
How big a problem are SSIs, specifically in the US?
In the US, and first of all the economic burden. As I said earlier, I suppose 10 billion economic burden is huge. It’s also about economic, but also a very significant burden from the medical point of view. Because actually, bacteria is everywhere. That’s the issue. Now when bacteria is everywhere, it’s also in the OR, in the operation room. And now when you do a surgery, that means you’re exposed to bacteria and with all the related burden, means and the waste. That means you have to protect yourself very, very well. You have to protect the patient and the physician and the situation, in order to prevent the bacteria to take over and actually to create infection in the wounds. Now that means huge economic burden to the system, just because bacteria is there. And that means that when you fail and there is infection, that means of course infection. But the related result will be a significant morbidity, high cost of treatment. Diagnostic, readmissions, hospitalization and even mortality is very significant. So take it all together, that’s the 10 billion burden to the system.
How is PolyPid using its innovations to enhance infection control?
First of all, PolyPid developed a system named PLEX. And that stands for polymer-lipid encapsulation matrix, that’s the technology that people, that PolyPid is using. Now, the PLEX technology actually enable a very precise and prolonged delivery of any API and any drug in the local site. What you do here is you can localize your treatment directly where it’s needed, at the site and not in the circulation, but directly in the wound in the case of operation and SSI. And then you can control the release of the drug over prolonged periods. When I’m saying control, means I can control or we can control by the technology the duration of the treatment. Also the dimension, meaning the concentration of the drug inside the wound. By that, we can actually prevent the bacteria to grow at the site and help the immune system to eradicate that. With that, we can actually not only overcome the bacteria in general and reduce SSI. But also it can overcome resistant bacteria, to antibiotics.
As you know, that resistant bacteria is a very significant burden. And resistant bacteria, that means actually that the current treatment cannot actually eradicate the bacteria. And why is that? Because now the current solution is systemic treatment. Every patient before surgery … and sorry, that get antibiotics, to IV antibiotics about half and hour to one hour before surgery. Now antibiotic cannot penetrate well into the site, into the incision. Why is that? Because first of all, only a small portion we’ll get into the tissue. That’s one. Second, most of the antibiotic will not penetrate. Because of the incision, there is no blood supply. Now local solution, basically will be the best solution. Because now you can bring the antibiotic directly to the site, and that’s exactly what we do. Now the high concentration that can be now generate can overcome bacteria that needs high concentration to be eradicated. That’s systemic, cannot do. So altogether, what we do is local delivery. Can overcome bacteria in general in the wound, but also bacteria that will be resistant to antibiotics. By that, we can reduce significantly the burden of SSI.
How big an impact can PolyPid have on the future of post-operative care?
I believe it’s a very, very significant impact. First of all, about SSI. The PLEX technology allow you to reduce SSI very significantly. And when I’m saying very significantly, it means at least 50% reduction in the rate of SSI. And that’s huge, even 60% and 70% according to our clinical studies. By that, you can reduce first of all of course morbidity, but also economically that can be very significant. For instance just as an example in abdominal surgeries, infection can be 30%. 30% of the patient will suffer from SSI, and now morbidity can be huge because of that. In sternal infection, another indication, mortality can be as high as 40%. Now think about the reduction of 60% and 70% for this type of burden, that’s huge reduction in terms of health, in terms of economic burden. So we believe that this solution, a very simple solution. That will be applied during surgery, will be during a very short time. Several minutes, two minutes, three minutes long, no more needed and very minimal training. That’s sufficient to eradicate huge problem. That the actually elevated infection rate, but also the economic burden to the system.
Any closing thoughts?
For the closing, first of all we are really excited to participate in such, I will say it is a very, very important issue. We live with bacteria for decades, and actually from ever been. And bacteria is everywhere, I said, we are exposed to that all the time. And we have some quiet years, because of the development of antibiotics. We felt sufficiently protected by antibiotics. But today now, resistant bacteria is raising hell and that’s a very tough battle against bacteria. We are participating in this battle, and we believe that we have a tool to win and to allow more safe surgeries. This is a burden that many are now appreciate, and there is a lot of discussions around the burden of SSI and the significance of that. Also on the COVID-19 situation, the use of huge antibiotics and the elevated number of resistant bacteria. Also in the Congress now, they are discussing exactly that.
Because that’s a real epidemic now and we are very happy to participate in that and allow a very simple tool in order to eradicate that, overall sufficient to reduce a very significant burden by a very short application. And by that, protecting the patients, protecting the health care system. They will come, the people who think twice and even three times before they will go to surgery. Just because of the infection, because of resistant bacteria. And that will change the game completely. Now with a very efficient tool, it will change the game for sure.