October 2020 Type C meeting planned with the FDA for NTM-006, an oral new chemical entity with a novel mechanism of action targeting neuropathic pain
Based on recent FDA guidance letter, Neumentum believes there is clear understanding of the regulatory path forward for NTM-001, a Phase 3-ready potent NSAID targeting moderately severe post-surgical pain
Neumentum remains committed to transforming the way pain is treated – without opioids
PALO ALTO, Calif., July 23, 2020 (GLOBE NEWSWIRE) -- Neumentum Inc., a pharmaceutical company dedicated to transforming the way pain is treated – without opioids – today provided a corporate update on notable business accomplishments and priorities for its two lead product candidates NTM-006 and NTM-001.
“Our broad portfolio of assets targeting multiple types of acute and chronic pain through novel and known mechanisms are well positioned to address the sizeable pain market and ongoing opioid crisis,” said Scott Shively, chief executive officer of Neumentum. “We continue to make significant progress with NTM-006, a new chemical entity non-opioid, non-NSAID analgesic candidate under development for neuropathic pain and other moderate-to-severe chronic pain conditions, and NTM-001, a 24-hour continuously infused non-opioid analgesic (Toradol PMB), which is a Phase 3-ready intravenous product for moderately severe acute and particularly post-surgical pain.”
Business Highlights and Recent Developments
- NTM-006 is an oral new chemical entity with a novel mechanism of action (MOA) targeting neuropathic pain, with positive efficacy data from a single dose Phase 2a study; the product may have the potential to replace opioids. Its presumed MOA, an Adenosine A3 Receptor Modulator (ARM), suggests unique analgesic activity. NTM-006 was recently in-licensed to Neumentum from Johnson & Johnson, which developed the asset through Phase 2a. Clinical results from the Proof of Concept (PoC) Dental Surgery Phase 2a study in moderate to severe pain showed significantly superior efficacy of NTM-006 to acetaminophen 1000mg for the endpoints of SPID (Summed Pain Intensity Difference) 0-12 hours and 0-24 hours, and longer duration of analgesia than acetaminophen (at least for 24 hours after a single dose). No serious adverse events were observed and NTM-006 was overall well tolerated and safe.
- Based upon the presumed MOA and PK/PD analyses recently conducted by the company, Neumentum’s development program for NTM-006 will optimize the opportunity in neuropathic pain. The neuropathic pain market is large and underserved, and it is predicted to grow to approximately $8 billion and to approximately 27% of the chronic pain market in 2028. The company will meet with the U.S. Food and Drug Administration (FDA) during a Type C meeting scheduled for October 2020 to discuss the next steps in the development of NTM-006.
- NTM-001 is a novel Phase 3-ready Pre-Mixed Bag formulation of Toradol (ketorolac tromethamine) that has the potential to be the first nonsteroidal anti-inflammatory drug (NSAID) ever approved for the U.S. market for continuous infusion. NTM-001 is a potent NSAID targeting moderately severe post-surgical pain that necessitates opioid-level analgesia. Robust Phase 1 pharmacokinetic data suggest the product has the potential to be the first ever continuously-infused, 24-hour non-opioid analgesic offering a low or no opioid post-operative analgesic protocol.
- Based on the recent guidance letter received from the FDA, Neumentum has a clear understanding of the regulatory path forward for NTM-001, providing for rapid Phase 3 development. The company intends to initiate its Phase 3 pivotal, post-bunionectomy efficacy study following consummation of its next round of equity financing.
- In addition to these two novel, late-stage, analgesic assets, Neumentum also has an early-stage analgesic asset portfolio consisting of four additional products.
About Neumentum: Addressing a National Health Emergency
Opioid use is considered a critical public health concern in the US. In 2018, 9.9 million people over age of 12 reported misusing prescription opioid pain relieversi. More than 70 million surgical procedures are performed in the U.S. annually and postsurgical pain is routinely treated with opioid analgesics.
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 limitations and risks for abuse and misuse that come with opioids. Neumentum’s NTM-001 (novel, alcohol-free formulation of ketorolac in a pre-mixed bag for continuous IV infusion), has the potential to treat moderately severe acute pain that requires analgesia at the opioid level for up to 24 hours, usually in a postoperative setting, and to reduce the need for opioids. Additionally, NTM-006, a product that is neither an opioid nor a nonsteroidal anti-inflammatory drug (NSAID), has completed a positive Phase 2A clinical study in moderate to severe acute pain. Neumentum is led by a world-wide 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.
INVESTOR CONTACT:
Scott Shively
CEO & Co-founder
scottshively@neumentum.com
(833) NEUPAIN
MEDIA CONTACT:
Surabhi Verma
Westwicke, an ICR company
Surabhi.Verma@westwicke.com
646-677-1825
[i] SAMSHA, Key Substance Use and Mental Health Indicators in the US: Results from the 2018 National Survey on Drug Use and Health. P13, Fig 10.