In an exclusive interview with The Fly, Rigel Pharmaceuticals (RIGL) CEO and President Raul Rodriguez discussed the recently announced investigator-sponsored trial being conducted by Imperial College London to evaluate the efficacy of fostamatinib, its oral spleen tyrosine kinase, or SYK, inhibitor, for the treatment of COVID-19 pneumonia. The executive also talked about Tavalisse's potential "large opportunity" in COVID-19 and the "more enduring opportunity" in non-COVID pneumonia.
COVID-19 IST: Rigel announced earlier this week the initiation of an investigator-sponsored trial, or IST, being conducted by Imperial College London to evaluate the efficacy of fostamatinib, its oral SYK inhibitor for the treatment of COVID-19 pneumonia. Fostamatinib, marketed in the U.S. as Tavalisse tablets, is approved in the U.S. and Europe as a treatment for adult chronic immune thrombocytopenia. "We believe SYK inhibition – which is the mechanism of Tavalisse – is very important in the progression of this virus," CEO Raul Rodriguez explained to The Fly.
"We're very interested in exploring this possibility of the use of Tavalisse in COVID pneumonia and its progression in humans. The fastest way of getting that done is through these IST, or investigator-sponsored trials, because they have the infrastructure already set and going in terms of recruiting patients and executing on the trials. They can do small trials kind of like this but the answer can come fairly early as well, like later this year. We have a high level of interest in doing IST trials in the U.K. and others in the U.S. so we can demonstrate the utility of our product in a couple different type of settings. Next step after that would be for us to launch our own trial; maybe a larger trial but now with some data that already demonstrates the utility of our product," Rodriguez added.
On Monday, shares of Rigel jumped after two analysts highlighted a study conducted by the Broad Institute of MIT and Harvard that cited fostamatinib as a potential candidate for treating acute lung injury related to COVID-19. Cantor Fitzgerald analyst Kristen Kluska argued in a research note to investors that the study results, and the supportive safety profile of fostamatinib, support additional studies of the drug in treating COVID-19. "The MIT and Harvard study is very exciting. It’s independent of ours; we didn’t sponsor it in any way," the executive noted.
TALAVISSE'S ADVANTAGES: Rigel believes Tavalisse approval in the U.S. and Europe as a treatment for adult chronic immune thrombocytopenia gives it an advantage in "a couple of different ways." "One is definitely safety," the CEO pointed out. "We've studied this compound in over 4,000 patients already - quite a large number of patients in the clinic. And in addition, we've dosed thousands of patients more. So, the safety database for the product is quite extensive and we know the product very well. It’s quite manageable in terms of any safety issues."
The other advantage seen by the company relates to manufacturing and distribution. The executive noted that, "we have the product manufactured, we can manufacture more, and the timeframe from being able to use the product if there is a clinic benefit is very quick. Conceivable, doctors could be using this almost immediately because the product is available and in the market in the U.S. and Europe. That's a real advantage. It takes a long time to set up a distribution system, set up manufacturing and scale that up. We've done that already. Other compounds that are in mid clinical trials or just pre-clinical, they don’t have scale of manufacturing in place to do it already nor the distributing system that follows, and we have that already in place."
MARKET OPPORTUNITY IN COVID-19: Several pharmaceuticals and biotech companies are currently developing potential treatments for COVID-related injury as the pandemic continues to spread worldwide. "I think it’s a very big market. It’s hard to forecast in COVID pneumonia because we don't know how large or small the pandemic will be going forward and, at some point, there will be a vaccine, I hope. But we're seeing a very large number of hospitalizations. In the U.S., unfortunately, I think there will be more than we had hoped earlier this year. So, it's a very, very large number of patients that will be hospitalized and unfortunately progress to pneumonia. It's a very large opportunity and there’s room for a multitude of different products with different mechanisms," the executive contended.
NON-COVID PNEUMONIA: While Rigel sees the COVID-19 opportunity as "an immediate and large opportunity," the company also believes there is "a more enduring opportunity" in non-COVID pneumonia. “There's an opportunity in pneumonia from non-viral sources and ARDS that is also very large. That one is a more enduring opportunity. It's an annual opportunity as it happens in an annual basis. Our long-term objective is to help address that opportunity. So, hopefully we'll help COVID pneumonia and its progression now but in the future, this will also help us demonstrate the utility of our product in that large and ongoing need in non-COVID pneumonia," Rodriguez added.
PRICE ACTION: In Thursday morning trading, shares of Rigel have gained about 3% to $3.37, extending gains that began early this week following the Citi and Cantor call outs.
