26 September 2019

Navega Therapeutics becomes a trusted partner of the HEAL Initiative to stem the opioid epidemic

Navega receives a SBIR grant to support the development of novel gene therapies to ameliorate chronic pain

San Diego, California. September 26, 2019.

Navega Therapeutics is excited to announce that the company has been awarded a Small Business Innovation Research (SBIR) Phase I grant from the National Institute of Health under the National Institute of Neurological Disorders and Stroke (NINDS), as part of the Helping to End Addiction Long-term Initiative, or the NIH HEAL Initiative. This program aims to improve treatments for chronic pain, curb the rates of opioid use disorder and overdose and achieve long-term recovery from opioid addiction.

Chronic pain affects more than 100 million people in the U.S. with over 25 million Americans living with high-impact chronic pain. Therapeutic options for these patients consist mainly of opioid narcotics, which come with risk of addiction. Navega Therapeutics aims to develop a non-addictive gene therapy for chronic pain, to improve the current paradigm of pain treatment.

"It's clear that a multi-pronged scientific approach is needed to reduce the risks of opioids, accelerate development of effective non-opioid therapies for pain and provide more flexible and effective options for treating addictions to opioids" said NIH Director Francis S. Collins, M.D., Ph.D., who launched the initiative in 2018. "This unprecedented investment in the NIH HEAL Initiative demonstrate the commitment to reversing this devastating crisis".

Navega takes advantage of the genetic studies that have correlated a rare hereditary loss-of-function mutation in one channel isoform – NaV1.7 – with a genetic disorder known as Congenital Insensitivity to Pain (CIP). Individuals with CIP are insensitive to pain without other neurodevelopmental alterations. Thus, selective inhibition of NaV1.7 should recapitulate the phenotype of CIP. The grant will be utilized for the further development of Navega’s gene therapies that are highly specific and potent.

At the end of Phase I, Navega shall know the potency, specificity, and safety of the optimized gene therapy and will apply for a Phase II SBIR grant to perform IND-enabling toxicology studies. Navega’s goal is to advance this therapy forward into the clinic, to provide an alternative treatment to opioids for patients with chronic pain.

Research reported in this press release will be supported by the NINDS of the National Institutes of Health under Award Number R43NS112088 titled “Repression of Sodium Channels via a Gene Therapy for Treatment of Chronic Neuropathic Pain”. The content is solely the responsibility of Navega Therapeutics and does not necessarily represent the official views of the National Institutes of Health.


About SBIR | The NIH small business program is a congressionally-mandated set-aside program to encourage research and development leading to commercialization. The small business program at NINDS is used to achieve the mission of the Institute by supporting innovative ideas at different stages of development, including applied bench research, translational research, and early stage clinical trials. Learn more about the program on https://www.ninds.nih.gov/Funding/Small-Business-Grants.

About the NIH HEAL Initiative | In April 2018, NIH launched the HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. This Initiative builds on extensive, well-established NIH research, including basic science of the complex neurological pathways involved in pain and addiction, implementation science to develop and test treatment models, and research to integrate behavioral interventions with Medication-Assisted Treatment (MAT) for opioid use disorder (OUD). NIH has worked with experts from public and private organizations to identify the areas that would most benefit from focused efforts by NIH alone or in partnership with outside organizations. The NIH HEAL Initiative℠ will bolster research across NIH to improve treatments for opioid misuse and addiction and enhance pain management.

About Navega Therapeutics Inc. | Navega is a preclinical stage company pursuing a radically different approach to treat chronic pain and tackle the opioid epidemic. Our gene therapy platform has the advantage of being highly specific and long-lasting, which has not been achieved by small molecules thus far. Our approach includes addressing different types of pain in order to improve the quality of life of millions of patients.

To learn more visit https://navegatx.com/ or contact us at info@navegatx.com