Obesity is considered to be excess fat accumulation that may lead to health issues. Worldwide, the prevalence of obesity has greatly increased over the years; the World Health Organization (WHO) notes that 650 million people globally were considered obese in 2016. However, for some people with obesity, POMC, PCSK1, and LEPR gene mutations are the cause. According to Fierce Pharma, Rhythm Pharmaceuticals (“Rhythm”) is looking to address this issue with Imcivree. In fact, Imcivree recently received the first-ever FDA approval for this type of obesity medication.

Imcivree

Specific genetic mutations cause difficulty in hunger regulation. As a result, some patients experience severe and unrelenting hunger (hyperphagia). On top of that, their genetic conditions make it difficult to control obesity with typical measures like exercise or diet. While the medical field has previously advocated for patients to pay attention to calories and other factors, the inability to regulate hunger plays a huge role in the current discussion.

In this case, Imcivree works by targeting the MC4R pathway. As Rhythm describes:

The melanocortin-4 receptor (MC4R) pathway, a key component of the central melanocortin pathway, regulates hunger, caloric intake and energy expenditure, consequently affecting body weight. A functional MC4R pathway balances our energy intake and energy expenditure to help maintain a stable body weight.

Rhythm licensed Imcivree in 2010 and has since worked to identify potential genetic causes of obesity that the drug can combat. It also licensed a specific FluidCrystal injection technology from Camarus in 2016.

Although the company is currently exploring Imcivree in relation to POMC, PCSK1, and LEPR gene mutations, the company hopes to expand and explore other mutations in the future. In fact, Rhythm will continue evaluating Imcivree in relation to two additional mutations through Phase 3 clinical trials. Currently, 2mg Imcivree is administered subcutaneously daily for a 2-week period. However, Rhythm is searching for a less invasive and more efficient administration technique. Additionally, Imcivree has been shown to be well-tolerated, effective, and safe.

Rhythm believes that doctors should pay additional attention to children and adults with hyperphagia, as it may suggest a genetic underpinning. If a patient presents with hyperphagia and obesity, doctors should consider genetic testing to get to the root of the issue.