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Arisaph's ARI-3037MO For NASH

Arisaph Pharmaceuticals Inc. is a private company with a focus on treating cardiometabolic disease. Currently, it researching a niacin analog (ARI-3037MO) for the treatment of hyperlipidemia and non-alcoholic steatohepatitis (NYSEARCA:NASH). These trials are assumed to have already completed their primary endpoints. Thus, we can expect data from the company at some point in the very near future. Both the hyperlipidemia and NASH studies are expected to conclude sometime in December 2016. A very good data readout might help the company either go public and/or get further private funding to help advance ARI-3037MO.

Funding

According to PitchBook, Arisaph "raised $2.5 million of Series H venture funding from undisclosed investors on December 21, 2015, putting the pre-money valuation at $51.1 million. Previously, the company received $1.59 million of grant funding from Department of Health and Human Services in 2014."

Late to the Game

A test performed on mice fed a high fat diet suggested that niacin has the potential to treat NASH patients. "The findings indicated that inclusion of niacin at 0.5% and 1.0% doses in the HF diet significantly decreased liver fat content, liver weight, hepatic oxidative products, and prevented hepatic steatosis. Niacin treatment to rats with preexisting hepatic steatosis induced by the HF diet significantly regressed steatosis." However, there is currently no inidication that niacin therapy can or will go beyond early stage NASH because data suggests that niacin has the potential to accelerate NASH fibrosis. It may seem that niacin analogs may not have a place in NASH therapy. However, early stage NASH therapies may also help in reducing the chance of a reoccurrence of later stage liver damage due to NASH (likely liver fibrosis and/or scarring of the liver). You can remove the fibrosis all you want, but removing the liver fat accumulation that leads to fibrosis is much more important for long-term patient outcomes. Thus, investors must not discount early stage NASH products such as Arisaph's niacin analog, ARI-3037MO.

Although Intercept is likely to be first in treating NASH, it is still unclear if doctors will choose to use it. Intercept has adverse events that are much more noteable than the disease itself. Many do not know they have the early onset of NASH. Further, many do not know that they have the more serious form of NASH that brings about liver fibrosis. Lastly, even if Intercept is successful in bringing Ocaliva to market for NASH, its pricing model might limit its potential to tap the patient population, especially when there are so many other products in the pipeline that show similar safety and efficacy results. Lastly, these other NASH therapies will likely be cheaper than Ocaliva and thus will put pressure on its market price. Thus, I look forward to seeing more from Arisaph soon.

Additional disclosure: I do not have a position in ICPT or Arisaph. Do your own due diligence.