Chief Executive Officer Scott Shively said the acquisition of an oral analgesic from Johnson & Johnson will be transformative for California-based Neumentum Inc.
Chief Executive Officer Scott Shively said the acquisition of an oral analgesic from Johnson & Johnson will be transformative for California-based Neumentum Inc.
On October 10, the two-and-a-half year-old Neumentum announced that it struck a deal with J&J subsidiary Janssen Pharmaceuticals for the rights to a novel oral analgesic, JNJ-10450232, plus a portfolio of backup compounds. In an interview with BioSpace, Shively said JNJ-10450232 is a novel molecule that has already gone through a few Phase II trials, including a IIa dental pain study. The analgesic is being eyed as a potential treatment for acute pain. The fact that the asset is neither an opioid nor an NSAID (nonsteroidal anti-inflammatory drugs) made it an intriguing target for the company, which was founded with a mission to develop non-opioid pain treatments.
While JNJ-10450232 is not yet fully understood, Shively said they believe the asset is an adenosine A3 receptor, which is seen as a new mechanism in pain applications. While the drug asset blocks pain, much like an opioid or NSAID, it does not have the same kind of concerns attached to it, such as addiction or gut and liver bleeds. In the Phase II trials the asset has already undergone, Shively said the results of JNJ-10450232 have been encouraging. Neumentum plans to position the drug for a broad indication in acute pain, Shively said. The medication could be used for post-surgical pain treatments, oral pain, back pain and more.
“There’s a huge market out there,” Shively said. He added that there is a significant need for pain medications that are safe and effective.
Terms of the deal with J&J were not disclosed, nor were the other assets in the licensing agreement.
While opioids are largely successful in blocking pain, the addictive side effects are taking their toll across America and many manufacturers are feeling the bite of multiple lawsuits aimed at their aggressive marketing tactics. Purdue Pharma filed for bankruptcy as part of a $12 billion settlement and J&J, the company with which Neumentum struck the deal, paid out $20 million to settle lawsuits in Ohio. According to the National Institutes of Health, about 115 Americans die daily from overdosing on opioids, which includes illicit drugs, as well as prescription medications. As more and more patients, prescribers and pharmacists are recognizing the dangers of opioid-based pain medications, multiple companies are developing non-opioid treatments for pain.
If successfully developed through additional clinical trials, and if ultimately approved by U.S. Food and Drug Administration, Shively said JNJ-10450232 and Neumentum’s additional portfolio of compounds may provide new options for pain relief. In addition to the mid-stage JNJ-10450232, Neumentum’s lead candidate is a Phase III-ready formulation of the NSAID ketorolac being developed for short-term management of moderately severe acute pain that typically requires opioids to address. That asset, NTM-001, is designed for continuous infusion in post-operative settings when something like morphine is typically used, Shively said. It’s the first NSAID designed for continuous infusion, Shively added. He noted that for many people who become addicted to opioids, their first exposure is often in a hospital setting with a morphine drip.
“That’s why we were founded. We want to offer an alternative to opioids. The focus of our company is to acquire, develop and commercialize non opioid pain medicines,” Shively said of his company, which has primarily been in stealth mode since its founding.
Over the remainder of 2019, Neumentum will be in the process of finalizing Phase III plans for NTM-001. It was only last month that Neumentum presented its Phase I data on NTM-001 at PAINWeek 2019. The findings presented at the conference show that NTM-001 provides consistent, steady blood plasma levels of ketorolac over 24 hours. Also, the data shows that the asset was safe and well-tolerated by patients.
In addition to getting NTM-001 ready for Phase III, Shively said the company will complete the transition of the J&J asset over the next few months and begin some pre-Phase III work on the asset ahead of seeking approval to launch a late-stage trial. Shively predicted JNJ-10450232 could enter into Phase III in early 2021 if all goes well.
The company will also be eye another financing round. Neumentum has already raised about $19 million and, with the growing interest in non-opioid pain treatments, Shively said investors are becoming keenly interested in the company’s pipeline.
