Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR) pharmaceuticals is trading at $19.94 per share at the time of writing this article after climbing 41.42% so far today. The gains are the result of clinical data released by the company. This data will be presented in more detail at the 18th World Gastroenterologist Summit in New Zealand shortly. Here’s what’s happening:
The treatment the data was regarding is known as ARO-HBV. It is the company’s third generation subcutaneously (under the skin through a needle) administered RNA interference (RNAi) treatment. The drug takes advantage of the company’s proprietary Targeted RNAi Molecules platform. The treatment is being developed in hopes of it becoming a cure for patients with chronic hepatitis B virus (HBV) infection.
In the release, Arrowhead Pharmaceuticals offered up quite a bit of data. The first set of data comes from the eight patients in the lowest two dose cohorts. These doses include 100mg and 200mg doses.
The data from these cohorts demonstrate that three monthly doses of ARO-HBV led to a maximum reduction of circulating HBV surface antigen (HBsAg) of 4.0 log10. Mean reductions came in at approximately 2.0 log10 on day 85 in the 100mg cohort and 1.4 log10 on day 71 in the 200mg cohort. In the release, the company said that all eight patients achieved greater than 1.0 log10 reductions in circulating HBsAg.
The Safety data proved to be just as promising. The data suggest that ARO-HBV was generally well-tolerated and that adverse events were generally mild and self-limiting injection site events that occured in around 10% of injections. The company also said that symptoms consistent with upper respiratory tract infection and headache were reported.
As a result of the strong data, Arrowhead said that it intends on submitting a late-breaking abstract with additional clinical data to Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Disease (AASLD), being held in November 2018.
Along with the strong clinical data, the COO of the company, Bruce Given, M.D., offered a compelling statement. Here’s what he had to say:
These initial results from the first two multiple-ascending dose cohorts of the AROHBV1001 clinical study are encouraging and indicate that ARO-HBV is highly active. In addition, the drug appears to be generally well-tolerated, which is consistent with our experience to date with ARO-AAT, our TRiMTM enabled candidate for the treatment of Alpha-1 liver disease. We intend to submit late-breaking abstracts to the AASLD Liver Meeting for both ARO-HBV and ARO-AAT, and, if accepted, we look forward to presenting more complete data-sets, including additional dose levels and longer follow-up.
The takeaway here is simple. With today’s data, it’s clear that Arrowhead Pharmaceuticals is working on a treatment that’s overwhelmingly promising. HBV infections are deadly and providing an effective cure to the market would likely lead to significant gains in revenue. So, while the stock is up big today, the gains may just be the tip of the iceberg.