NAFLD is one of the leading causes of liver damage in the younger population. The increasing NAFLD prevalence runs parallel with the increasing trends in obesity among people. However, this does not imply that the lean population does not get affected by it. Global NAFLD prevalence is estimated to be as high as One Billion. In the U.S., NAFLD is one of the most common causes of chronic liver disease, known to affect between 80 and 100 million individuals, out of which around 25% of the cases take the nasty form of NASH.
According to DelveInsight, a substantial increase in obese, and diabetic population will significantly result in an increase in the prevalent cases of NAFLD. The estimates suggest that the NAFLD prevalence is expected to advance with the CAGR of 1.02% for the study period i.e. 2017–2028 in the 7MM. Moreover, out of which, 19% of the diagnosed NAFLD cases had the potential to progress into NASH. In addition to being a clinical burden, NASH imposes a higher economic burden as well. As estimated by Younossi ZM. Et.al, in the US alone, accounts for around an annual expenditure of USD 10-15 Billion.
One of the biggest challenges is the diagnosis of the disease. In most of the cases, patients do not realize that they are suffering from the NASH until it has advanced to higher stages. Hence, is known as the silent killer. The only way to confirm the NASH is a liver biopsy. And the process of biopsy is expensive, burdensome and carries the risk of side effects.
NASH Treatment and Upcoming trials
The treatment of NASH depends on the severity of the disease. Currently, NASH therapies consist of supportive and off-label therapies due to lack of targeted treatment option. Lifestyle modifications such as weight-loss and active exercise regime are, however, the first line of treatment. Medications are prescribed to the patients when lifestyle modifications fail to bring upon any improvements.
Insulin-sensitizing agents such as metformin are prescribed in some instances, however, due to their inability to provide long-lasting relief they are not recommended often. The other one, Pioglitazone, is suggested in selective patients already suffering from Type II diabetes.
Vitamin E has shown very significant results and is prescribed in most cases. It is not recommended for patients with diabetes, NASH cirrhosis or cryptogenic cirrhosis. Statins are also prescribed in cases when a person has the cardiovascular risk associated with NASH. Statins are not recommended until histologic data are available.
Lack of management of the disease, proper cure, and targeted therapies are the highest unmet needs in NASH. Amore in-depth and effective treatment regime is required to improve the quality of the patients. Due to available scope in the NASH market and various sorts of uneasiness to the NASH patient pool, several Pharma giants are advancing the NASH pipeline and working to improve the NASH treatment landscape.
Failure of Gilead Sciences lead drug, Selonsertib, took the NASH market by surprise. The result of STELLAR-3, a Phase 3, randomized, double-blind, placebo-controlled clinical study announced that its oral daily drug did not meet the criteria for an efficient NASH treatment. However, the company is collaborating with other companies for an effective treatment for NASH.
Another large-cap pharma firm, Allergan, is working to improve the pipeline of many disorders for diseases affecting the eyes, bowel, lungs, skin, urogenital systems, and brain. Cenicriviroc (CVC) is Allergan’s major candidate for NASH treatment. The clinical success of CVC in Phase II trials has led it moving forward to Phase III trials.
These Pharma giants are not only confined to conducting clinical trials of their investigational drugs. They are also involved in acquisitions and mergers with suitable pharma giants to advance the NASH pipeline further. In the year 2016, Allergan acquired Tobira Therapeutics for USD 1.7 Billion, and in a similar manner, Gilead acquired Nimbus Apollo for USD 470 Million.
Other Pharma companies like Johnson & Johnson and Pfizer and Novartis as one combined force are working towards improving the NASH therapeutic options. The pharmaceutical companies are trying their best to improve the NASH therapy area, however, the end result is based on the clinical trials of the drugs and lead candidates being tested.