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Upstream Benefits Signal The Making Of The Next Giant Drug Class

New technologies typically don’t address one specific problem. The path to becoming an important force multiplier with population-level impacts is the uncovering of additional benefits that tend to scale economically.

GLP-1s are in this discovery phase whereby analysts are periodically updating NPV models to capture new benefits and new demographics and new indications with little change to the underlying technology.

Goldman Sachs estimates US GDP growth will improve as a result of the GLP-1s.  And on March 8, 2024 the FDA approved the use of Wegovy to reduce the risk of cardiovascular death, heart attack, and stroke in adults with heart disease with obesity or overweight.

 

Here are some key upstream benefits:

  1. Increased Investment in Research and Development

The success and growing demand for GLP-1 drugs are leading to increased investments in R&D. Pharmaceutical companies are more willing to allocate resources to explore new applications of GLP-1 receptor agonists, develop improved formulations, and identify novel GLP-1 analogs. This, in turn, can lead to advancements in treatments for diabetes, obesity, and potentially other metabolic disorders. Research is ongoing into dual agonists that target both GLP-1 and other receptors, such as glucose-dependent insulinotropic polypeptide (GIP), to further enhance metabolic effects.

  1. Innovation in Drug Delivery Systems

As GLP-1 drugs become more popular, there is a push to improve drug delivery systems. Innovations such as oral GLP-1 drugs, longer-acting injectable formulations, and more patient-friendly delivery methods (like wearable devices or patches) are being actively researched. These advancements can enhance patient adherence and overall treatment efficacy. Approval of oral GLP-1s (pills) will greatly enhance acceptance of this new drug class.

  1. Enhanced Understanding of Metabolic Pathways

The study and application of GLP-1 drugs are driving a deeper understanding of metabolic pathways and how they can be manipulated for therapeutic benefit. This knowledge benefits the development of GLP-1 therapies and informs the broader field of metabolic disease research, potentially leading to new treatment targets and strategies.

  1. Economic Growth and Job Creation

The burgeoning GLP-1 market contributes to economic growth within the pharmaceutical industry. Increased production, research, and development activities create jobs and stimulate economic activity. This growth can also benefit related industries, such as biotechnology firms, contract research organizations (CROs), and manufacturers of drug delivery devices.

  1. Collaboration and Partnerships

The success of GLP-1 drugs fosters collaborations and partnerships between pharmaceutical companies, academic institutions, and healthcare providers. These collaborations can lead to synergistic advancements, combining clinical insights with innovative research to optimize GLP-1 therapies and explore new indications.

  1. Regulatory Advancements

As GLP-1 drugs become more prevalent, regulatory agencies are gaining more experience with these therapies, potentially leading to streamlined approval processes for new GLP-1 drugs and indications. This can facilitate faster access to innovative treatments for patients. The pace of FDA approvals is quickening.

  1. Improved Patient Outcomes

Ultimately, the upstream benefits culminate in improved patient outcomes. Better management of diabetes and obesity through effective GLP-1 therapies can reduce the incidence of related complications, improve quality of life, and decrease healthcare costs associated with these chronic conditions.

  1. Broader Therapeutic Applications

There is ongoing research into the potential applications of GLP-1 receptor agonists beyond diabetes and obesity. Preliminary studies suggest possible benefits in areas such as cardiovascular health, neuroprotection, and even certain types of cancer. As these drugs gain momentum, more therapeutic applications may be discovered and developed.

  1. Personalized Medicine

The growth of the GLP-1 market is also driving advancements in personalized medicine. By understanding how different patients respond to GLP-1 therapies, researchers can develop more tailored treatment plans, improving efficacy and reducing side effects.

Here are two examples:

Cardiovascular

 

Recent research has highlighted the cardiovascular benefits of semaglutide, a GLP-1 receptor agonist, in patients with obesity but without diabetes. The SELECT trial demonstrated that weekly doses of 2.4 mg semaglutide significantly reduced the risk of major adverse cardiovascular events (MACE) by 20% compared to placebo. This included reductions in nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death. The study involved over 18,000 participants with preexisting cardiovascular conditions, confirming semaglutide’s potential in mitigating cardiovascular risks in this population​

Sleep Apnea

 

The SURMOUNT-OSA phase 3 trial investigates the use of Tirzepatide for treating obstructive sleep apnea (OSA). Tirzepatide is a novel dual agonist primarily developed for type 2 diabetes and obesity management. Given the significant association between obesity and OSA, researchers are exploring Tirzepatide’s potential benefits in this context.

Rationale

The rationale for the study is based on the following considerations:

  1. Association between Obesity and OSA: Obesity is a major risk factor for OSA, and weight loss has been shown to improve OSA severity.
  2. Tirzepatide’s Mechanism of Action: By targeting both GIP and GLP-1 receptors, Tirzepatide enhances insulin secretion, suppresses appetite, and promotes weight loss, potentially reducing the severity of OSA.
  3. Potential Benefits Beyond Weight Loss: Tirzepatide may improve cardiovascular and metabolic health, which are often compromised in OSA patients.

Design

The trial is a randomized, double-blind, placebo-controlled study with the following key design elements:

  1. Participants: Adults diagnosed with OSA, typically confirmed by polysomnography.
  2. Intervention: Participants receive either Tirzepatide or a placebo, administered via subcutaneous injections.
  3. Duration: The treatment period is sufficiently long to observe significant changes in weight and OSA severity, usually spanning several months.
  4. Endpoints: Primary endpoints include changes in the Apnea-Hypopnea Index (AHI), a measure of OSA severity, and body weight. Secondary endpoints may include measures of metabolic health, quality of life, and cardiovascular outcomes.

Sample Baseline Characteristics

The baseline characteristics of the sample population typically include:

  1. Demographics: Age, gender, ethnicity, and BMI.
  2. OSA Severity: Baseline AHI scores indicating mild, moderate, or severe OSA.
  3. Comorbidities: Prevalence of type 2 diabetes, hypertension, and other metabolic conditions.
  4. Medication Use: Baseline use of medications for diabetes, hypertension, and other conditions.

Results

The research shows that patients sleep apnea improved a lot. Sleep apnea is diagnosed using an apnea hypopnea index (HPI) which is the number of times you stop breathing or pause your breathing for about 10 seconds. In this study, the AHI index improved by about 63% which is about 30 less episodes of patients stopping breathing.

 

 

Upstream Benefits Signal The Making Of The Next Giant Drug Class was last modified: May 14th, 2024 by Simons Chase