How Does Elysium Therapeutics' Hydrocodone Prodrug, O2P, Work?

ACT: Could you tell our audience a bit about O2P and its development journey?

Greg Sturmer: When you look at the key features of O2P, and we talked about these inherent risks of existing opioids, I think you could probably put them into four different buckets. One of the inherent risks of existing opioids relates to oral abuse, and fatal overdose. Another is non-oral abuse and fatal overdose. A third diversion: giving your pills to someone else, or someone else getting a hold of your pills, and addiction. Let's just briefly talk about those. Oral abuse and fatal overdose; what O2P does, we reduce the exposure to the opioid, in this case, hydrocodone when more than recommended doses are ingested. So this reduces the risk of abuse and fatal overdose. And we actually demonstrated this in our human proof of concept study that we recently completed. O2P also provides, and this quite frankly, we exceeded our expectations. When we did our human study, O2P actually provides a longer duration of action than existing opioids. That means that when a prescription is given for an O2P hydrocodone, it will take fewer tablets, significantly fewer tablets, and what fewer tablets means, coupled with our oral overdose protection, is we’re further reducing the risk of opioid abuse, diversion, and fatal overdose. Just to put this in perspective, there's been a lot of effort of late to restrict the number of days that a doctor can prescribe. So even in that context, say that a doctor is only allowed to give eight days’ worth of pain relief, there would be no potential for lethal overdose with O2P. Even if someone took the entire bottle on day one when they received it. And that compares to existing opioids where there would be eight potential lethal overdoses. So that's kind of the stark contrast that our technology is bringing forward.

Next, in the non-oral route of abuse and fatal overdose, I already touched upon this, so I don't mean to talk about it much further, but our technology relies on this natural digestive process, so injecting or inhaling is not going to release hydrocodone. What we've also done, though, is made it really difficult to tamper with. We sent our drug, actually, to an independent lab, and said, “Beat it up, see if you can get the hydrocodone out of it.” And the results showed how robust our technology is. The third issue of diversion, I think I may have mentioned this before, over 70% of abusers, they obtained the prescription opioids that they abused from friends or family, so they're not getting prescribed directly. They may have at the beginning, but now they're relying on getting it from other sources. Well, O2P reduces the risk of diversion by significantly reducing the number of pills that will be prescribed. And then finally, when you talk about risks of addiction or abuse that might lead to addiction. Each prescription will have far fewer potential euphoric episodes. An abuser, what they're looking for is, “I want to get high. I want to feel these euphoric effects as fast as I can, as long as I can, and as many times as I can.” And unfortunately that “as many times as you can,” that's that reinforcement of behavior that can lead to addiction. So with O2P opioids, we can dramatically reduce the number of euphoric episodes that would reinforce that type of behavior.

Finally, the cool thing about our technology is it's applicable to all oral opioids. So we're first applying it to hydrocodone because it's the most prescribed opioid, but next could be oxycodone, morphine, oxymorphone, hydromorphone, and then also O2P opioids that are used for opioid use disorder like buprenorphine and methadone. So a lot to be done within the opioid space, and much could be done outside of the opioid space as well with our technology.