Frost & Sullivan has extensively investigated the increasingly central role that monoclonal antibodies (mAbs) are playing in oncology and other fields to alleviate pain. Read about some novel therapies.
Pain is a complex sensory and emotional experience, and the causes are as much physiological as they are psychological. The International Association for the Study of Pain said that it is the most common reason for a clinic visit. This is understandable, because pain is often a symptom of an underlying disease or condition: the starting point for most clinical referral tends to be an unbearable or unexplainable sense of pain.
The National Institutes of Health and other organizations estimate that between 50 million and 100 million Americans experience chronic pain. This does not include children and hundreds of millions more who suffer from acute pain. Besides affecting lifestyles and livelihoods, pain is also an economic burden on the health care system and on the country. It is estimated that Americans collectively spend more than $100 billion on pain management every year.
Several pharmaceutical and non-pharmaceutical options are available for the treatment and, more often, management of pain. One of the most used—and abused—options is the use of opioids, a class of strong painkillers that are routinely prescribed. In fact, societal dependence on prescription (and non-prescription) opioids has led to what even government agencies are calling a “crisis.” Prescription drug overdose has become the leading cause of death among people under the age of 50, and is being cited as the single most impactful reason for the declining life expectancy of Americans. The psychological term to describe the futility of using large numbers to make a point is called statistical numbing; still, it is clear that the world needs an alternative to opioids for the management of pain.
Monoclonal antibodies (mAbs) have been investigated against a variety of pain conditions. The monospecific antibodies produced by identical immune cells are isolated, purified and used for immunotherapies—the practice of using proteins produced by the body to trigger the necessary immune response.
Frost & Sullivan has extensively investigated the increasingly central role that mAbs are playing in oncology and other fields. They are particularly celebrated for their specificity in targeting ligands that are part of the disease pathway. In the case of neuropathic pain, for example, a mAb binds to biomarkers that signal pain and inflammation. Their long half-life could mean that a small dosage would be sufficient for long-lasting impact.
Frost & Sullivan has profiled some novel mAb therapies that are being investigated for the management of different types of pain.
Tanezumab for chronic lower back pain
Two of the largest pharmaceutical companies—New York-based Pfizer and Indianapolis-based Eli Lilly—partnered to develop tanezumab, a mAb that targets nerve growth factor (NGF). NGF is responsible for the creation and regulation of pain sensitization states. Its concentration in a site increases when there is localized inflammation, injury or chronic pain. Tanezumab, still under investigational use, can bind to NGF and inhibit the activation of signaling pathways in neurons that trigger pain sensitization. In July 2017, the U.S. Food and Drug Administration granted a fast-track designation for tanezumab for the treatment of chronic lower back pain.
Fasinumab for osteoarthritic pain
New York-based Regeneron Pharmaceuticals is developing fasinumab, a fully humanized mAb that also targets the NGF. In the third quarter of 2017, Regeneron initiated a Phase III efficacy study to compare fasinumab with placebo in patients with osteoarthritic pain in the knees or the hip. Regeneron has also licensed the mAb to Israeli pharmaceutical major Teva Pharmaceuticals, which plans to use it to investigate an anti-migraine therapy.
Anti-Nav1.7 antibody for pain and itch
Researchers at Duke University in Durham, N.C., are working on an early-stage mAb that could specifically block the Nav1.7 sodium channel without affecting other sodium-gated ion channels in neurons. Nav1.7 is a specific subtype of the sodium channel that is partially responsible for controlling pain sensation in the nerves. Early studies conducted in animal subjects have proved to be promising, but considerable developmental work is pending to translate this candidate into a clinical option.
Galcanezumab for migraine management
In January 2018, Eli Lilly reported that its mAb candidate, galcanezumab, was successful in reducing and preventing migraines when compared with placebo controls. The encouraging result, after more than a year of study across 37 clinical sites and involving more than 400 participants, will accelerate market entry this year. Eli Lilly intends this to combat cluster headaches and chronic and episodic migraines.
The Road Ahead
The fact that most if not all of the mAb candidates for pain management are still under clinical testing should not come as a surprise, not least because drug development is an arduous, time-consuming and scrutinized process. However, the tremendous success that mAbs have had in the field of oncology and autoimmune diseases has been a tipping point for this type of therapy. It is just a matter of time before these pipeline candidates are approved for various types of pain.
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