In the latest installment of our occasional conversations with Fort Worth leaders, Suchismita Acharya, the founder and CEO of AyuVis, discusses the importance of immunotherapy and her startup’s current project. 

This conversation has been edited for length and clarity. For an unabridged version, please listen to the audio file attached to this article.

Alexis Allison: What is AyuVis?

Suchismita Acharya: AyuVis is a startup pharmaceutical company in Fort Worth, Texas. It’s a near-clinical stage company that has been here since around 2014. We are developing small molecule therapeutics for immunotherapies for multiple indications that involve both inflammation as well as infection. Currently, we are focusing on respiratory indications. But this class of small molecules can be used for the whole body.

Allison: Wonderful. Can you tell us, first, about where the name comes from?

Acharya: Oh, sure. I love to say that. I’m a very big fan of Mother Nature and the resources Mother Nature provides us. The name AyuVis comes from two words: One is Ayurveda, which is a traditional Indian medicine based on medicinal plants. And so the first three letters come from there, and then “vision” is the Vis. So we have a vision to convert a naturally derived compound to a new drug.

Allison: Thank you for sharing. That leads me to my next question about immunotherapy. How would you define it?

Acharya: So immunotherapy, you might be hearing this buzzword a lot. So, what is immunology in terms of thinking about our body’s natural defense? It could be a bacteria, virus or fungus — when we get any external attack, then our body is always ready to respond to that. We have a system in place, it’s like a defense mechanism. These immune cells in our lymphatic system are always circulating in the blood and they recognize if we have a pathogen or microbe and how to engulf that, and then kill it — kind of like a trash compactor. 

Our white blood cells are always circulating, but when we have an (intruder) like a bacterial infection, they become too active. So they want to kill the bacteria, but at the same time, they spit a lot of unwanted molecules, which are also known as cytokines. Those cytokines are very harmful to other tissues or organs in our body if we don’t control them. You might have heard this term called “cytokine storm,” and the cytokine storm actually leads to organ failure, death, sepsis, those kinds of indications. 

So we don’t want to activate our immune system too much, but at the same time, we also don’t want to suppress our immune system. So, what AyuVis’ small molecule is doing is bringing a balanced scenario, where we have a mild activation to kill the microbes and then a compensation or increase in anti-inflammatory things that will help in recovering the tissues from injury and dysfunction. We are bringing a very novel approach, which is to bring a balance to the immune system. And that’s what we all need: We don’t want too much activation. We don’t want immune suppression. That’s the uniqueness of our technology.

Allison: AyuVis’ current project is working on the lungs of preterm babies. Can you tell us a little bit more about that?

Acharya: Our first indication we are going after is a condition called bronchopulmonary dysplasia. In short, we call it BPD. BPD is a chronic lung injury, and this is actually caused by (treatment in) our neonatal intensive care units that’s supposed to help the babies breathe when they’re born preterm and their lungs are underdeveloped. They can’t breathe on their own, so we supplement them with oxygen in the NICU so that they can survive. That’s a good thing. 

But the bad thing is, if they are kept on the ventilator for months, they go through oxygen toxicity, and their lungs get permanent damage. So basically, their lung walls thicken and cannot exchange oxygen the way our lung cells should. So there is no flexibility in these lung cells to exchange the oxygen and carbon dioxide when we breathe in and breathe out. These babies, once they develop that condition, carry it throughout their life. And there is no FDA-approved treatment to reverse this phenomenon. 

So this is a very high, unmet need and a niche field, and we have shown very extensive preclinical results both in small and large animal studies, that if we inject our drug intravenously early on, then we can prevent the development of BPD. We are using a preterm lamb (for our large animal studies), which mimics the condition of the babies. And these lambs are freely breathing after they come out of the invasive mechanical ventilator. So that’s what we want for these babies when they go home: They don’t have to carry a cylinder of oxygen with them at home so they can breathe freely, develop normally and live a long life. 

Allison: I know that AyuVis has received a patent for this drug. What’s the significance of a patent?

Acharya: This is a very important question, because patent protection or intellectual property protection is the bread and butter of any pharmaceutical company. We protect our technology so that somebody else cannot infringe without our permission, our license, (and we have) freedom to operate and market our drug. So that’s why patent protection is important. 

Allison: What’s next for this specific drug?

Acharya: The name of the drug is AVR-48. Based on our extensive preclinical data, (AVR-48) has also received orphan drug as well as rare pediatric disease designation from the U.S. Food and Drug Administration. That is a big milestone for us, because it helps us see that the FDA is definitely interested in this compound. 

Our next step is to go to the clinic and successfully complete the clinical trial in both adult as well as preterm babies. And once we complete those clinical trials successfully, we can go back to the FDA and ask for conditional approval. Because this is a rare disease, we want to show that, when there is no drug to treat these babies, and we have shown successfully the completion of the clinical trial, we get a conditional approval to manufacture and market the drug so it will be useful for the babies. Our goal is to start our first clinical trial by the end of 2022. Maybe in three to four years, we should be getting approval from the FDA. That’s our very ambitious goal. 

Allison: Thank you so much for sharing about this, Dr. Acharya. Is there anything else that you’d like to share?

Acharya: I would like to share an opportunity AyuVis is bringing in immunotherapy: the unique way of approaching immune balance, which is really dire need in a lot of diseases. We have seen what (COVID-19) did in the last two years, that acute lung injury that leads to cytokine storm and death. We need to have an arsenal in our pharmaceutical space to address this. We don’t have it. 

And the other thing I want to emphasize is the development of resistance to our existing antibiotics for bacterial infection. One of the things our technology (can address) besides the lung injury in BPD is bacterial infection, pneumonia and sepsis. And the key thing about our immunotherapy is, it’s bringing immune balance: making our own body stronger so we can fight against the bacteria. Because we are not directly targeting killing the bacteria, but making our body stronger, the bacteria will not develop resistance against our drug. This is a win-win situation. We can keep using the existing antibiotics, but when we augment with our therapy, it will have the largest benefit. So those are my future goals: To expand our pipeline after BPD and bring something that will make a huge difference in the immunotherapy field.

Alexis Allison is the health reporter at the Fort Worth Report. Her position is supported by a grant from Texas Health Resources. Contact her by email or via Twitter. At the Fort Worth Report, news decisions are made independently of our board members and financial supporters. Read more about our editorial independence policy here.

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Alexis Allison covers health for the Fort Worth Report. When she can, she'll slip in an illustration or two. Allison is a former high school English teacher and hopes her journalism is likewise educational....

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