Delpor, Inc. is a clinical-stage life sciences company that utilizes innovative technologies in order to develop once yearly therapies for chronic conditions, announced that the National Institutes of Health (NIH) has awarded the company a grant for the development of a Once-Yearly Naltrexone product for the prevention of relapse to opioid dependence. The award comes through the NIH Helping to End Addiction Long-term Initiative, or the NIH HEAL Initiative, which aims to improve treatments for chronic pain, curb the rates of opioid use disorder and overdose, and achieve long-term recovery from opioid addiction.
The award is part of the National Institute on Drug Abuse (NIDA) UG3/UH3 Phase Innovation Awards Cooperative Agreement involving 2 phases. Delpor is expected to receive up to $5.7 million during the UG3 phase for the first 2 years. If the UG3 milestones are met, NIDA may allow the Company to transition to the UH3 phase, and award additional funding during the following 3 years in order to complete the clinical development of the program. Funding for both grant phases is subject to satisfactory project progress, fund availability, and other conditions.
In 2017 over 11 million people misused prescription opioids, and over 2 million people reported having Opioid Use Disorder (OUD). Opioid overdose deaths in the U.S. exceeded 60,000 in 2017, and fentanyl-related overdose deaths increased by 45%. FDA approved medications, in combination with counseling and behavioral therapies, provide effective treatment of OUD. Medications for opioid use disorder work and save lives but are underused due to poor medication adherence, with therapy retention rates as low as 10%.
Delpor’s PROZORTM technology enables the sustained release of CNS drugs from a non-mechanical, matchstick-long, implantable drug delivery device based on a unique formulation. The device is implanted in the abdomen during a simple, 10-minute in-office procedure, and delivers therapeutic levels of the drug for as long as one year. Benefits include reduced relapses due to complete medication adherence for as long as one year after a single administration, and steady drug release without any sub-therapeutic troughs. The device may be easily removed within minutes in case pain treatment is needed due to injury or surgery.
Delpor’s award is one of 375 grant awards across 41 states made by the NIH in fiscal year 2019 to apply scientific solutions to reverse the national opioid crisis. “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 addiction to opioids,” said NIH Director Francis S. Collins, M.D., Ph.D., who launched the initiative in early 2018. “This unprecedented investment in the NIH HEAL Initiative demonstrates the commitment to reversing this devastating crisis.”
“We are very excited and honored to participate in the NIH HEAL Initiative” said Tassos Nicolaou, Chief Executive Officer of Delpor. “Our PROZOR technology platform has been validated clinically with our lead program, 6-12 month Risperidone for schizophrenia maintenance, and our prior work can be leveraged to further accelerate the development of a 1-Year Naltrexone product.”