- All 16 healthy normal volunteers (HNVs) were dosed and no serious adverse event was reported
- The NTM-001 Phase I clinical study is expected to be completed by the end of 2022
SHANGHAI, July 26, 2022 /PRNewswire/ -- Nuance Pharma ("the Company") announces the completion of dosing for all HNVs in the Phase I clinical study of its novel Ketorolac for IV infusion (NTM-001), a non-opioid analgesic drug co-developed with Neumentum. A total of 16 healthy normal volunteers (HNVs) were recruited for the Phase I clinical study. All subjects had completed sample collections up to 96 hours and passed a 15-day safety follow-up period. To date, there have been no serious adverse events or alarming safety concerns reported among any of the subjects. According to Nuance R&D head, sample data clean-up and statistical analysis are in progress. The Phase I clinical study is estimated to be completed later this year.
In late 2020, Nuance Pharma entered into an exclusive license agreement with Neumentum for the rights to develop and commercialize the novel intravenous infusion of ketorolac (NTM-001) in Greater China. The asset is currently in Phase III development in the U.S. for the short-term management of moderately severe pain.
"It gives me great pleasure to announce the smooth completion of Phase I dosing for NTM-001 in Hong Kong. This represents a crucial milestone for our collaboration with Neumentum and is indicative of a grand opening to the China clinical development program. NTM-001 provides injectable non-opioid analgesic to patients and will be a promising alternative candidate for the use of opioid drugs in analgesics," commented Mark G. Lotter, CEO and Co-Founder of Nuance Pharma. "We are looking forward to introducing this novel drug in Greater China to address unmet needs in the pain management market."
"We are very excited to have completed this important study for NTM-001, further demonstrating the safety of the compound," stated Joseph Pergolizzi MD, Executive Chairman of Neumentum. " We believe NTM-001 has the potential to significantly improve the standard of care for many patients experiencing moderately severe, acute pain requiring analgesia at the opioid level. We believe the results of this study further highlight the profile of NTM-001 as a potentially effective and safe short-term pain management solution and provide valuable information for the product's clinical program moving forward."
About Ketorolac (NTM-001)
Ketorolac (NTM-001) is a novel, alcohol-free formulation of ketorolac in a convenient, ready-to-use, pre-mixed bag for continuous 24 hours IV infusion, for the treatment of moderately severe acute pain requiring analgesia at the opioid level, usually in a postoperative setting with the potential benefit of consistent pain relief without the risks associated with opioids, or the disadvantages of bolus short-acting analgesics.
About Pain in Postoperative Period (POP)
In 2020, there was an estimated 66 million inpatient surgical operations in Chinese hospitals. 1) There is significant demand for pain management in the POP setting in China, driven by the huge inpatient surgery volume and double-digit growth rates. 2) In the POP setting, the main goal of pain management is to reduce pain or discomfort to the extent possible and minimize side effects at the same time. However, despite medical advancements in the last decades, opioids remain the backbone of POP pain management in the moderate to severe setting despite the serious side-effects. There is substantial need for a non-opioid pain management option that affords consistent, opioid-level pain relief that is, at the same time, safe to address the significant unmet medical needs in China's pain management market.
About Nuance Pharma
Nuance Pharma is a patient-centric and innovation focused biopharmaceutical company, with both clinical and commercial stage assets. Founded by Mark Lotter in 2014, with the mission to address critical unmet medical needs in Greater China and Asia Pacific, Nuance's portfolio represents a differentiated combination of commercial stage and innovative pipeline assets across respiratory, pain management, emergency care and iron deficiency anemia.
Focusing on specialty care, Nuance deploys the Dual Wheel model that incubates a late clinical stage innovative portfolio, while maintaining a self-sustainable commercial operation.
Neumentum is dedicated to becoming a leading non-opioid analgesic and neurology specialty pharmaceutical company with product candidates that have the potential to provide the benefits of safe and effective pain management, without the risks for abuse, misuse and diversion seen with opioids or the opioid-induced side effects, including potentially life-threatening respiratory depression. Neumentum is led by an experienced executive team of biotech and pharmaceutical industry leaders who have extensive experience in pain and neurology, from drug development through commercialization. For more information, visit www.neumentum.com.
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, which could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.
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1. https://www.statista.com/statistics/279392/number-of-surgery-procedures-in-chinese-hospitals-by-region, accessed July 2022
2. China analysis on the development of surgeries from 2015 – 2020, Ipsos MedTech, 2020 Sep 12
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Source: Nuance Pharma Limited