Semaglutide Access, Cost Issues Could be Addressed With New DNA Test

The MyPhenome Hungry Gut test, developed by Phenomix Sciences, may help predict patient responses to semaglutide, potentially reducing the uncertainty in treatment outcomes for patients with obesity who are increasingly turning to the medication, according to results of a Mayo Clinic study presented during the presidential plenary session at Digestive Disease Week 2024.¹

Newspaper headlines related to semaglutide-based Ozempic and Wegovy / zimmytws - stock.adobe.com

Semaglutide-based medications such as Ozempic and Wegovy have become household names in recent years, exploding in popularity due to their ability to promote weight loss. But although some clinical trials have shown impressive results, with patients achieving a reduction in BMI upwards of 15% while on the medications,² others have highlighted the variability in individual responses. These fluctuations suggest the need for more personalized treatment approaches to using semaglutide, especially as its cost continues to rise and drug shortages hinder its access.

Leveraging the genetic and biological bases that contribute to obesity, the MyPhenome swab test identifies patients with the hungry gut phenotype to determine who may respond well to semaglutide. The presence or absence of the phenotype, characterized by altered postprandial satiety, signals how soon patients may feel hungry again after eating. This data helps reveal which patients may be more likely to experience reduced hunger and improved blood sugar while on semaglutide, leading to more successful weight management outcomes.

To assess the effectiveness of MyPhenome in predicting patient responses to semaglutide, investigators recruited 84 participants with obesity who were prescribed semaglutide to take the assessment. Data were analyzed using the company’s Machine-Learning Gene Risk Score algorithm to determine if patients were hungry gut positive or negative.

READ MORE: Ozempic, Other GLP-1 Therapies Caused Major Increase in Medicare Spending

Strikingly, participants with the hungry gut phenotype lost nearly twice as much weight, reaching 19.5% total body weight loss (TBWL), compared to 10% TBWL among those without the phenotype, at 12 months.

“We are excited with the results of this independent study of Phenomix’s MyPhenome test at Mayo Clinic,” said Mark Bagnall, CEO of Phenomix Sciences, in a news release.¹ “Demand for semaglutide marketed as Ozempic and Wegovy, is at an all-time high; this study showed an ability to identify responders to semaglutide using our test. We are excited about what lies ahead in precision medicine for obesity and are hopeful our test will be a pivotal tool for clinicians across the US.”

Although the cost of semaglutide can vary, estimates show that the medication typically runs patients $1000 in out-of-pocket costs per month.³ What’s more, an increased demand for the drug has caused shortages persisting over multiple years and spanning multiple patient populations.⁴ These drug shortages have made it difficult for patients to fill their prescriptions and access continuous care, leading to disruptions in treatment plans and subsequent health complications.

MyPhenome is poised to address these issues in the obesity space by optimizing the use and distribution of semaglutide. The urgency for such solutions is only rising: By 2030, Morgan Stanley Research predicts the obesity drug market will surpass a staggering $77 billion, while other estimates predict that 1 in 2 US adults will be obese by the same time frame.^5,6

“Our results underscore the potential of individualizing therapy to improve outcomes that will ultimately translate into improved health,” said Maria Daniela Hurtado Andrade, MD, PhD, endocrinologist and assistant professor of medicine at Mayo Clinic and principal investigator in the study, in a news release.¹

Click here for more of our coverage from Digestive Disease Week 2024.

Pharmacy practice is always changing. Stay ahead of the curve: Sign up for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips, straight to your inbox.

References

1. Study demonstrates MyPhenome^TM Hungry Gut test identifies responders to semaglutide. News release. PR Newswire. May 20, 2024. Accessed May 22, 2024. https://www.prnewswire.com/news-releases/study-demonstrates-myphenome-hungry-gut-test-identifies-responders-to-semaglutide-302149284.html

2. Garvey WT, Batterham RL, Bhatta M, et al. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022;28(10):2083-2091. doi:10.1038/s41591-022-02026-4

3. Constantino AK. Novo Nordisk’s $1,000 diabetes drug Ozempic can be made for less than $5 a month, study suggests. CNBC. March 27, 2024. Accessed May 22, 2024. https://www.cnbc.com/2024/03/27/novo-nordisk-ozempic-can-be-made-for-less-than-5-a-month-study.html

4. Loftus P. Ozempic shortages to extend through 2024. The Wall Street Journal. November 21, 2023. Accessed May 22, 2024. https://www.wsj.com/livecoverage/stock-market-today-dow-jones-11-21-2023/card/ozempic-shortages-to-extend-through-2024-RyF6s44bizjC7X2OmOyj

5. Obesity drugs boost pharma’s growth outlook. News article. Morgan Stanley. September 6, 2023. Accessed May 22, 2024. https://www.morganstanley.com/ideas/obesity-drugs-investment-opportunity

6. Emery G. Half of US adults to be obese by 2030 with one in four severely obese. Reuters. December 18, 2019. Accessed May 22, 2024. https://www.reuters.com/article/idUSKBN1YM2IN/#:~:text=(Reuters%20Health)%20%2D%20A%20new,24.2%25%20will%20be%20severely%20obese.