Last weekend you had a news flow which you shared with your shareholders and more importantly with all the consumers that there is a drug which was used for psoriasis can be given to very severe Covid patients. Can you start by saying what has Biocon discovered? Have you got any feedback from any of the lead doctors from any states?
Covid-19 has created a huge sense of concern, fear and the mortality rate has been very challenging across the world. We realise that what was really causing the mortality was what they call the cytokines release storm. The virus basically not only induces antibody production but it also induces T-cells to trigger the release of cytokines in a very uncontrolled way. It was this uncontrolled cytokines storm that was creating a very intense autoimmune disease in the body which was eventually shutting down all the organs and causing death. Cytokines create huge inflammation in lungs and respiratory passages, leading to a drop in oxygen levels and then creating a lot of cascading destruction in the body.
With that in mind we looked at one of our drugs which is very well indicated for autoimmune diseases of this nature and which we have developed for psoriasis in India and then licensed it to a US company which was actually developing it for other autoimmune indications such as graft versus host disease, acute asthma and lupus nephritis.
When you look at the mechanism of action it seems that it could work in Covid-19. So we went to the regulators and we would like to try this drug in Covid-19 based on the hypothesis that this mechanism of action might help and with that we conducted a small proof of concept study in 30 patients where 10 patients were not given the drug and 20 patients were given the drug and to our surprise, we found that all 20 patients in the drug arm recovered whereas other three patients died.
This basically gave us very encouraging information with which CDSCO, the Drug Controller gave us an restricted emergency use authorisation to try out and continue to treat patients with Covid-19 and then do a phase IV trial to corroborate the findings of the small pivotal study that we had done. What is very interesting is that because this is an approved drug in India, many doctors have been using tocilizumab off label — which is an IL6 targeting antibodies and have been finding very good results with this drug.
Ever since we have got this emergency approval, we have actually been able to use it on many patients across the country with very promising results. That is all I can say at the moment right now. Obviously, our US partners are also very keen to start a trial in the US. So, we are working with them to start this soon and I think it is all very encouraging news for us because this could be a very very promising and large drug for us.
Not talking about the size and how big it could be at this point of time but could you elaborate more on the encouraging results? Initially, one would say that the study was not that big but it is an emergency situation and that is why you could do it on a limited number of patients. Going ahead, will more studies be conducted and the base expanded so that better results can be achieved?
That is expected of this study because as I mentioned to you this is a pivotal proof of concept study and in an emergency use situation, this is what all regulators allow you to do. This is not that you need large amounts of data because in an emergency, you want to take advantage of any promising data. This is what happened with Remdesivir, this is what has happened Favipiravir, with HCQ in our country. This is what is happening with many drugs in the US and India and many parts of the world.
You are basically trying to use anything that shows promise that is why it is called an emergency use authorisation and it is a restricted authorisation which will be approved when you have more data. In order to create that more data, we are going to do a phase-4 trial, which will encompass at least a few hundred patients to see whether this data actually is proving the same in these patients.
What we have seen in the first study and in many patients who have used off label is that there is a clear reduction in cytokines and that is the most important data that you have to look at. The data that you have to look at is the reduction of the cytokines and therefore the calming of the cytokine storm which then reduces the probability of mortality. That is the way you have to look at this drug and we are very encouraged and that is why the US partners want to quickly start a study in the US because the US also has a very high mortality due to cytokine storms.
We are getting a lot of news regarding vaccines, therapeutic treatments. What should one do in case of Covid? Over the next six months, do you expect more good news to come in? What could be the side effects, how long they would essentially last and what kind of patients will they work on?
There are three major questions that are being asked about all the vaccines under development; one is whether it is safe, two whether it is actually invoking both antibodies and T-cell response and the third is how enduring will the effect be. Right now, out of all the vaccines which are advancing in phase-3 or phase-2, the AstraZeneca vaccine looks very promising since it has not had safety concerns.
It has shown response both in T-cells and antibodies which is very good news. We need to see how long that effect will endure. You cannot answer all these questions in a very short time. I am very hopeful that by the end of this year, if this vaccine continues to show endurance at least for six months, we could have a vaccine by the end of this year.
On the other hand, you have the Moderna vaccine which of course has shown very good antibody response but it has not shown any T-cell response. So that is a big concern for immunologists. The second thing is it had a lot of adverse events so the safety question mark is there because the first doses have been given to healthy volunteers and if they have shown such adverse events, they are wondering how will it effect a larger general population. These are the concerns with the Moderna vaccine.
Of course, there are several other vaccines in the pipeline as well. In India also, we are very focussed on two of our own vaccines that are getting into phase-1. Phase-1 data is very important to see both safety and efficacy in terms of whether they induce both antibody and T-cell response that is all going to be very important. You need to watch this whole vaccine space very closely and let us hope that at least in the next six months, we should have a vaccine being released into the market.