Chances are good that you know someone – a friend, a co-worker, a neighbor, a family member – who suffers from some type of chronic pain.
At present, many types of therapy they might seek to help cure or ease that pain are limited in their efficacy and produce unfavorable side effects. Opioid therapies, as you probably also have heard, often lead to tolerance and addiction.
According to the National Institute on Drug Abuse, more than 115 Americans die every day after overdosing on opioids. The misuse of and addiction to opioids – including prescription pain relievers, heroin, and powerful synthetic opioids such as fentanyl – represent a serious national crisis that affects public health as well as social and economic welfare. The Centers for Disease Control and Prevention estimates that the total economic burden of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment and criminal justice activity.
For the past five years, Kineta Inc., a Seattle-based biotech company, has been developing a non-opioid therapy for the treatment of chronic pain that can, in part, help combat the problem of opioid abuse. This particular drug is derived from the venom of the Conus regius, a small cone snail native to the Caribbean Sea. Kineta’s conopeptide drugs have demonstrated robust analgesic, anti-inflammatory and neuroprotective effects across multiple animal chronic pain models.
To get a better sense of the work Kineta has been doing and how the company’s efforts might impact the nation’s opioid crisis, Crain’s spoke with Jacques Bouchy, Kineta’s senior vice president for business development and corporate communications.
Crain’s: Talk to me a little bit about the genesis of this. That Kineta wanted to work on a non-opioid, non-addictive painkiller makes sense given the opioid crisis. But was there initial trial and error? I'm curious how you came to work with a snail shell and if there were other possible sources that were explored initially.
Bouchy: Nature is quite sophisticated. We had been working with venoms, along with our colleagues from the University of Utah, and were interested in using the venoms to understand different pathways in the nervous system. It made sense us to explore this type of therapy given our existing relationships and work with venom.
Crain’s: Describe how the conopeptide-based drugs are similar to opioids and how they are different.
Bouchy: They’re actually quite different. Opioids work on the brain and mask pain systems. Your brain doesn’t even feel pain any longer. Our conopeptide drugs work in a very different way, at the source of the injury, producing analgesic, anti-inflammatory and neuroprotective effects.
Neuropathic pain results from damage to nerves. Once a nerve is injured (whether by trauma or other causes such as chemotherapy or diabetes), additional degeneration can be caused by the inflammatory response to the first injury. For this reason, neuropathic pain is very painful, chronic and difficult to treat. Most patients suffering from neuropathic pain report being dissatisfied with available treatments.
We also do not anticipate that it will have the central nervous system-related side effects, such as tolerance or addiction, associated with opioid therapies.
The conopeptide therapy is for use with chronic pain, and not acute pain. We’re developing this as a once-weekly subcutaneous injectable formulation.
Crain’s: How is it currently being tested?
Bouchy: We’ve been doing a fair amount of preclinical animal testing in the past two years. We will continue to study for safety and efficacy, aiming for human studies in 2019 and submitting for FDA approval by 2022.
Bouchy: What do you see as potential roadblocks or challenges at this stage of the development process?
All early-stage drugs have places where they might not work. But everything we’ve seen to this point has given us reason to be optimistic.
Crain's: Can you talk a little about funding, and who has helped support the development of this drug, as well as how it might be financed moving forward, in order to get it to market?
Bouchy: There has been a lot of media attention around chronic pain and there is considerable interest in our work from various investors and pharmaceutical companies. We really are looking to out-license or do some type of business development transaction with this asset with a larger pharmaceutical development. We actively collaborate with a broad array of private, government, biodefense and industry partners in an effort to advance our work.