Globavir is on course with clinical trials and a drug in the market for dengue fever may follow if successful.
Dengue fever affects 390 million people worldwide and kills many elderly patients as well as young children who get infected with this disease. While death happens to a smaller subset of patients, a more significant majority of patients can have debilitating consequences including muscle pains, inability to go back to work for months and bleeding complications that can cause extended hospital stays. One of the significant infectious disease in the 21st century still defies the scientific progress with no real cure in sight, no current treatment except for supportive care, and even more challenging is the diagnosis that happens to be missed many times.
Ageless Online talks to Dr Shalabh Gupta, president and CEO of Globavir BioSciences, who is working on developing a new drug for the treatment of dengue fever:
In June this year, an 84-year-woman died from dengue and became the fifth such death in Singapore. The other deaths were those in their 60s and 70s. You mentioned that there is no cure in sight, no treatment only supportive care and the diagnosis gets missed many times. Can you explain why more effort has not been put towards this significant infectious disease that kills many elderly as well as young children around the world?
Dr Gupta: It is not that efforts have not been made to identify cures for dengue, but essentially two things happened:
1. For a variety of reasons, many global pharma companies have focused on vaccination, rather than treatment. Vaccines may create larger market opportunities, but they have had challenges in terms of development timelines and also in terms of efficacy. Even with promising vaccines like one from Takeda, most experts agree that with vaccines alone this disease cannot be controlled. There is therefore an opportunity for treatment. Dengue affects 390 million patients and even with the best and most efficacious vaccine, it would take years to eradicate dengue completely – so there is the need for treatment.
2. A few global pharma companies like Roche have attempted to develop treatment for dengue in the past, but didn’t succeed in clinical trials. Globavir’s planned clinical trials will utilise learnings from these past failures. The science of new drug development is not always a straight line, but we have the benefit of learning from others who worked on this endeavour before us. In addition, we leveraged decades of research at Stanford University and are now working with some of the best minds in Singapore. We feel that we have a chance to change the world by advancing our drug as a cure for dengue.
So, what is currently available? You mentioned there is a vaccine for dengue fever that is approved in certain countries and there is another vaccine being developed. Is the vaccine available in Singapore?
Dr Gupta: As outlined above, there are two vaccines that one should know of – Dengivax, a vaccine developed by Sanofi, which until recently was approved in several different countries. It was pulled out of the Philippines recently because of potential complications from vaccination.
The second vaccine is a vaccine being developed by Takeda, which shows really promising results and could be available very soon. However, one of the challenges that remains is the potential public health aspects – and how different Governments across the world may decide to reimburse for these vaccines. In order to offer vaccination that would prevent dengue, you would want to offer the vaccine broadly. The question then is how you decide whom to give and whom not to give. And, if you decide to vaccinate everyone, there is potential added cost to healthcare expenses.
In addition, just because a vaccine is available in one country, it does not automatically mean that it will be available in all countries. The approval process for vaccines (and even for drugs) requires approval at a country-by-country level, and each Government agency must decide whether or not they approve such a vaccine and then whether or not they will reimburse for these vaccines. For example, Dengivax had challenges, and is not available in Singapore.
How does your new treatment compare? Tell me more about the new drug and how it treats the fever.
Dr Gupta: Our drug works at the host level – which is the human cell. So, we believe it has an advantage that it is not working on the virus but it is working by defending the human cells. In particular, it strengthens the host defenses against the virus entering into the cell and multiplying when it is inside the cell. By blocking these two core features, we believe our drug can work against new infection of human cells that are not infected, and also to by protecting human cells that already have the dengue virus – by preventing the virus from replicating (and ultimately causing cells to die by excessive multiplication within the cell).
I understand the new drug for the treatment of dengue fever is based on years of research done at Stanford University, and now you are planning to partner with Duke-NUS to start the clinical trials in Singapore. Why Singapore and how long will the trials take before the product can come into market? How many people will be participating? Will it be in the form of a tablet or an injection?
Dr Gupta: Our drug is intended to be a tablet – one tablet per day for three to five days and which is the anticipated duration for treatment. We are working on the other forms of treatment as well such as injectable and solution. Singapore offers world-class treatment facilities and has some of the world’s best researchers in dengue treatment. In addition, we found a true partnership spirit among both physicians and scientific community as well as in the administration at Duke-NUS and SingHealth. So, Singapore became our obvious choice.
We intend to test 50 patients for Phase II trial, which would take around six months to complete. For the Phase III trial, it would be a few hundred patients and we intend to run Phase III trials in a few different countries including Singapore. If the trials are successful, we expect our drug to be approved and on the market by 2021/22. We are working on some of the other logistics both with our team as well as with the Government agencies.
How did you get interested in dengue in the first place?
Dr Gupta: Dengue affects 390 million patients and kills mostly elderly and children throughout the world. While at Stanford, I found that some of the scientists had a potential drug and diagnostic tests for this disease – and that’s what led to me to think about taking the research done at Stanford and building on their work to bring a real-world treatment. I have spent my life as a physician, and a few years in finance and biotech industry before starting Globavir. This is truly my passion – to bring new medicines for diseases which have no cure. I couldn’t be doing what I do without the support of many others who are part of my team – and they include various scientists, physicians from Stanford, from Duke-NUS, our investors, our scientific advisory board members, our science team, and our partners who help us run the trials. It is a team sport, and no one can win this game without everyone playing their A game.
What is your hope or wish for the new drug?
Dr Gupta: We want to find a cure for dengue – no matter what. We believe that our drug can be a solution to this problem. Our diagnostic tests make it easier to identify those who have dengue and differentiate it from other similar infections like Zika or Chikungunya.
We strongly believe that in the 21st century, we cannot be chasing mosquitoes alone to cure diseases like dengue – while controlling mosquitoes is one way to control the disease, new treatments addressing the disease are equally important.
(** PHOTO CREDIT: Unsplash)