Insider buying is heating up at Corbus Pharmaceuticals Holdings Inc (NASDAQ:CRBP) again. Having bottomed along with the rest of the biotech sector in February, shares have been on a tear as critical phase 2 data readouts get closer, with two big ones scheduled for the end of this year. Corbus in some ways is riskier than some other trial stage biotechs because its pipeline is not diversified. It is a one-drug company as of now with the earliest new drug application (NDA) approval estimated by the company at 2021, more than five years away. What makes it attractive though, despite having a one-drug pipeline, is that it has both fast track and orphan status for two indications, and that the one drug it is developing has the potential to treat a vast array of diseases. There is even some chance that upcoming data readouts could spur a bid for the company by Big Pharma.
Corbus Pharmaceuticals Holdings Inc (NASDAQ:CRBP)’s drug is called Resunab, otherwise known as ajulemic acid. Unlike most new molecular entity drugs that are often entirely engineered and unknown to nature, Resunab is based on a naturally occurring molecule that is widely known for its anti inflammatory properties. It is a cannabinoid mimetic, meaning a slightly tweaked form, and cannabinoids have long been known for exhibiting strong anti inflammatory properties.
The two data readouts scheduled for the end of 2016 are for cystic fibrosis and scleroderma. The former is a genetic disorder, the latter autoimmune, but both exhibit symptoms that are greatly exacerbated by chronic inflammation. In cystic fibrosis, lungs that cannot clear out excess phlegm often get infected, triggering a natural inflammatory response that only increases phlegm and makes the condition even worse. In scleroderma, also known as systemic sclerosis, the immune system attacks the skin, resulting in something like a very severe form of psoriasis. Psoriasis is also autoimmune, but generally is restricted to the epidermis. Systemic sclerosis affects the deeper skin structure.
There are two forms of scleroderma. One is limited and only affects the skin, and the other is diffuse. Diffuse is much worse and often life-threatening, where the immune system targets internal organs as well. Corbus Pharmaceuticals Holdings Inc (NASDAQ:CRBP) is trialing Resunab for the diffuse version of the disease. Here, too, inflammation plays a major role as the immune system basically triggers the inflammatory response throughout every organ affected. Inflammation itself is beneficial when the body is trying to clear an infection, but it’s like a scorched earth policy. Making the body inhospitable to bacteria can help kill the infection, but it also takes a big toll on the body itself. Constant inflammation will eventually cause fibrosis and death, whether it is caused by a genetic disorder like cystic fibrosis or an autoimmune disorder like diffuse scleroderma.