A Call for Help from Physician Specialists on the Frontline Treating MASLD/MASH

Exton, Pennsylvania, July 18, 2023 (GLOBE NEWSWIRE) — Data from the Centers for Disease Control & Prevention (CDC) suggests just over seventy percent of American adults are overweight, including 40% being clinically obese.   Nearly twenty percent of children are obese, rising from 12% of those 2-5 years of age to over 22% of those 12-19 years of age.  

Analysis from the NIH identified the origin of the US obesity epidemic starting in the late seventies, when the prevalence was roughly 15%, rising steadily through the turn of the century to 30% and continuing to present day.   Worldwide, the rise of obesity has seen similar growth, with the World Health Organization (WHO) citing a tripling of prevalence since 1975.   Shockingly, the WHO data shows most of the world’s population live in countries where excess weight and obesity kill more people than underweight conditions.

It is no surprise to find obesity-associated disease rising at a commensurate rate.  The Journal of Hepatology reports the prevalence of Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly referred to as non-alcoholic fatty liver disease (NAFLD) increased over 50% in the last three decades.   Newly published data from Spherix reveals over two-thirds of MASLD patients struggle with comorbid obesity (Spherix Market Dynamix^TM  – NAFLD/NASH).   More than half of gastroenterologists and hepatologists surveyed by Spherix expect the prevalence of the disease to continue rising and correspondingly, the number of patients diagnosed and needing treatment.   The same is true for the more severe form of the disease – metabolic dysfunction-associated steatohepatitis (MASH – formerly designated NASH).

MASLD/MASH encompasses a complex constellation of medical issues both associated with and causing liver dysfunction.  

• “In a sense, fatty liver is an umbrella term with several different phenotypes…most often a hepatic manifestation of the metabolic syndrome in tandem with obesity, type 2 diabetes, hyperlipidemia, hypertension cardiovascular disease…The most common, of course is the metabolic phenotype, with the metabolic syndrome. But I would highlight that I don’t view this as a purely metabolic condition”

        – US Gastroenterologist

When managing patients with MASLD/MASH, Spherix found both gastroenterologists and hepatologists call out weight reduction as a critical clinical outcome to achieve across every stage of the disease.   Without approved drugs, doctors are left to manage patient weight through diet and exercise, or in extreme cases, gastric surgery.   While the vast majority of physicians believe diet and exercise will always remain a primary intervention, a nearly equal number agree patients have limited success achieving clinical goals through diet and exercise alone.

Physicians interviewed by Spherix stressed the need for comprehensive support to help achieve and maintain weight loss – nutritional and exercise counselling, technology monitoring and enablers, and pharmaceutical therapies.   A partnership is needed between patients, doctors, and broader healthcare providers to change the context of treatment to one of prevention over time.   A key learning from the Spherix study highlighted the important role primary care providers will need to play managing the patient demand: 

• “For those who we determine in our hands to have early disease, we actually refer them back to the primary physician because it’s not a good use of resources to have us as liver specialist manage low-risk patients. They’re just far too many patients with fatty liver… So, to care for all patients with fatty liver is not practical.”        – US Gastroenterologist

A practical outcome found in the Spherix study clarifies management of MASLD and/or early MASH patients is best suited in primary care, focusing on weight, metabolic, and other factors implicated in MASLD.    This will leave specialists the capacity to focus on later stage MASH where rehabilitating fibrotic liver damage is most critical.

The need to address obesity and weight loss was punctuated by gastroenterologist and hepatologist responses to several eminent MASLD/MASH therapies in development.   While most called out therapies addressing fibrosis reduction – the most pressing medical issue of concern for their patients – over half stated an intent to prescribe semaglutide (a GLP-1 receptor agonist, brand name Ozempic) should it receive FDA approval, despite semaglutide failing to achieve a phase 2 clinical endpoint in fibrosis reduction.   This suggests the specialists are seeing value in the weight loss benefits semaglutide provides to patients.   Indeed, several physicians Spherix interviewed called this out specifically: 

“[Semaglutide] has shown a remarkable ability to help patients lose weight and control diabetes.”
– US gastroenterologist

“Effective in patients with NASH-cirrhosis and BMI of 27 kg/m2 or more in safely reducing weight, lowering HbA1c in those with diabetes, and improving several key metabolic parameters.”                         – US gastroenterologist

Several newer drugs are in development to support weight loss needs, with hopes they will help curtail obesity in the coming years, including:  Mounjaro/tirzepatide (Eli Lilly), Cagrisema/semaglutide-cagrilintide (Novo Nordisk), ecnoglutide (Sciwind Biosciences), mazdutide (Innovent Biologics – licensed to Eli Lilly), retatrutide (Eli Lilly), ARD-101 (Aardvark Therapeutics), and NNC0165-1875 (Novo Nordisk). 

The weight loss therapies may better fit in the primary care setting, while the promising late-stage therapies treating liver fibrosis and compensated liver damage –  including Madrigal’s resmetirom, Galmed’s aramchol, and Inventiva’s lanifibranor – fit neatly into the gastroenterologist and hepatologist domain of expertise.   Gastroenterologists and hepatologists see each of these drugs as significant advancements forward, with two-thirds expecting to prescribe each should they become available.

Manufacturers prepared to educate patients and primary care doctors, foster balanced patient demand across healthcare providers and clarify which therapies address the constellation of issues spanning MASLD/MASH disease stages, will likely find a favored position in the hearts and minds of doctors contending with the growing healthcare burden.

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