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High inflation is rocking the markets, as interest rates are skyrocketing, and access to capital is dwindling. However, some small biotech companies are weathering the storm. in this interview, Robert Foster, CEO of Hepion Pharmaceuticals, will discuss strategies for being competitive in this harsh economic environment.
Moe Alsumidaie: What are the three most significant challenges that Hepion Pharma's clinical operations are facing, and how are they being addressed?
Robert Foster: The first significant barrier is funding for our Phase IIb clinical trial. We must keep a close eye on our spending to survive the trial. The second most difficult challenge is determining how long the study should last. Many other companies needed 12, 15, or 18 months to assess. However, based on the mechanism of action of our drug, rencofilstat, we decided that 12 months would be sufficient. This was one of the factors we considered when designing the duration of this trial, as the primary goal is to see if there is a decrease in fibrosis or a change in steatosis. Our third challenge is to enroll patients quickly. The sooner we can provide interim or final information to our shareholders, the better. One strategy we employed was increasing the number of sites, so we opened 121 sites. The third challenge is related to the first because the cost increases as the number of sites used increases. You must concentrate on the bottom line regardless of the size of your biotech company.
MA: What is the best way to balance funding, study operations, and patient recruitment?
RF: I've learned that if funds and financing are available to run your programs or business, you should use them. People frequently believe that accepting the money now will be dilutive, so they wait, hoping that the share price will rise. In contrast, my experience has taught me that predicting what will happen in the market is impossible. It would help if you also considered inflation and the global economy's strain. You can be caught in a downdraft regardless of your program’s effectiveness. As a result, despite the pandemic, we could accept a substantial amount of cash when the opportunity to finance arose at the end of 2020 and the beginning of 2021. The second point to mention is that we also hired exceptional talent. We hired a highly experienced chief medical officer from a large pharmaceutical company a year and a half ago. I've always believed that surrounding oneself with the most talented brightest people is beneficial.
MA: Hepion Pharma is conducting a placebo-controlled, double-blind study for the Phase IIb "ASCEND-NASH" trial. Why is this strategy so crucial for commercialization and competitiveness?
RF: To ensure that the drug's effect can be accurately measured, FDA requires a placebo-controlled blinded trial. However, if you are interested in reducing fatty liver, one challenge involves lifestyle change, such as diet and exercise. Some people may be more likely to watch their diet and exercise when they begin a trial, and chronic liver disease and now NASH, are examined, there is frequently a high placebo effect. For instance, if your drug has a 25% effect, you must consider how much of that effect is due to the drug alone and how much could be due to a change in lifestyle. A placebo-corrected response is possible, and that is what we are aiming for here. FDA will require a pre- and post-trial biopsy to be competitive. We attempted to establish a "safety valve through a series of interim analyses." The Drug Safety Monitoring Board (DSMB) will evaluate rencofilstat's safety, tolerability, and effectiveness. They cannot tell us the efficacy of the trial because it is blinded, but they may be able to give us a general sense of whether they see compelling reasons to continue the study. We are testing three different dosages, and the DSMB may inform us that the low dose does not have many effects. Or they could say that high doses are risky, so you should discontinue either the low dose for lack of efficacy or the high dose for safety. We anticipate that reconfilstat will be effective at all three doses being tested.
MA: What are the benefits of directing AI POWR with multi-omics?
RF: Our drug classes are entirely different from our NASH drug development market competitors. Our proprietary artificial intelligence is known as AI POWR (AI). We received drug approval for lupus nephritis, a drug we discovered and developed at our previous company, in January 2021. AI and our efforts to make this molecule successful played a role in its success. We're taking the same approach at Hepion, but we're stepping up our efforts. The genome, transcriptome, proteome, lipidome, and metabolome are all studied. Millions of data points are generated for each patient when the multiome is combined with patient characteristics such as BMI, gender, and age. Then the effect of rencofilstat on the movement of all these different markers is examined. We are distilling this massive data set down to the elements that will tell us who will respond best to the drug. We can avoid the pitfalls that have plagued other companies with mediocre response rates, especially considering the placebo effect. And we're looking into ways to boost response rates to 70%, 80%, and 90% by prescribing our drug to suitable patients. Fatty liver disease affects one-third of the population in the United States, and we want to make our therapy available to those who benefit most from it.
MA: In Phase IIb, you have 121 sites and 336 patients.
RF: Yes, they will be divided into three dose cohorts. We divide dosages into three categories: low, medium, and high. The low dose is 75 milligrams, the medium dose is 150 milligrams, and the high dose is 225 milligrams. These three doses will be given once a day for a year. For this trial, we will recruit the majority of subjects with a NASH score of F3
MA: Have you considered incorporating decentralized clinical trial models into Hepion's Phase IIb?
RF: I prefer a more conservative strategy in a more controlled setting. Because patients are frequently quite ill with liver disease, so returning to clinics is highly inconvenient. We want to ensure that our trials are as precise as possible when comparing the placebo response to the drug treatment response.
MA: At the moment, inflation is causing capital markets to tighten. Is this a challenging situation for a pharmaceutical startup?
RF: Yes. It impacts access to capital, and many businesses are in limbo. At the same time, there are a lot of great deals on the market right now. This is something I've been doing for about 35 years. I've seen these cycles come and go, and I know they always come back. Fortunately, we invested during a period when the market was highly volatile—excited and eager to invest in companies like ours. Given the strength of our cash position and the tenacity of our team, we will do everything we can to be resourceful and weather the storm. Hepion is an excellent company with unique action mechanisms. We have an oral drug that directly targets or affects fibrosis. It is highly safe and well-tolerated, and the cost to produce the drug is affordable.