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Development of a novel translational pain-drug screening platform for the generation of human-relevant data in preclinical pain drug discovery

Award Number: R43DA052947
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2020
PERIOD OF PERFORMANCE END DATE: 09/29/2022

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Development of a novel translational pain-drug screening platform for the generation of human-relevant data in preclinical pain drug discovery - ABSTRACT Chronic neuropathic pain, which is one of the most common forms of chronic pain, is a highly prevalent condition that dramatically decreases productivity and quality of life; it is often associated with insomnia, anxiety and depression, and does not respond well to existing treatments with >50% of patients who are refractory to current medications. Additionally, many pain relief medications are highly addictive, and may involve numerous issues with withdrawal and risks of overdosing. In 2017, more than 47,000 Americans died from an opioid overdose, according to the Centers for Disease Control and Prevention, causing a National Emergency. Thus, there is an urgent need to develop non-opioid analgesics to treat chronic neuropathic pain. To date, attempts at developing novel analgesics have been and continue to be hindered by high clinical attrition and cross-species translational difficulties, resulting in lack of efficacy in pivotal Phase II clinical studies. A very promising avenue for advancing pain research is provided by the recently-established possibility of performing of studies directly on human sensory neurons. Functional, electrophysiology-based studies of human nociceptive neurons are now possible, allowing the direct phenotypic screening and drug candidate profiling in human tissue- based assays at the preclinical stage. This approach has the potential to overcome many of the limitations associated with cross-species differences encountered when using animal models of pain for the identification and selection of clinical drug candidates. AnaBios has developed a novel translational drug screening platform for the generation of human-relevant data in preclinical pain drug discovery. Over the past 9 years, we have developed methods that enable the recovery and interrogation of hDRG; these technologies allow for studies aimed at advancing knowledge of basic pain biology as well as supporting drug discovery efforts. For preclinical-stage drug development programs it is critical to assess: 1) the potential of a new drug candidate in human-relevant models; 2) the activity in specific pain states; 3) the potency. Our proposal aims at introducing new in vitro models to enable the assessment of potential analgesic activity, directly on human samples, at early preclinical stages. Specifically, the development and qualification of in vitro models of pathological states associated with pain is a central goal of the proposal. The availability of qualified pathological models will provide a highly valuable tools for advancing the development of new non-addictive drugs for the treatment of pain. The utilization of primary human cells in translational research and drug discovery can provide data that are essential for addressing two critical translational challenges: the selection of the dose for first-in-human studies and, the selection of the appropriate patient population for proof of concept pivotal Phase 2 clinical studies. This proposal will advance the development of our novel screening platform and will ultimately help bypass the cross-species translational hurdles which have impeded the progress of pain drug development for decades.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2020	ANABIOS CORPORATION	3030 BUNKER HILL ST STE 312	SAN DIEGO	CA	92109	SAN DIEGO	USA	Drug Use and Addiction Research Programs	000	1	9/19/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $320,054 )
2020	2020	ANABIOS CORPORATION	3030 BUNKER HILL ST STE 312	SAN DIEGO	CA	92109	SAN DIEGO	USA	Drug Use and Addiction Research Programs	000	1	9/15/2020	NEW	$320,054
														Subtotal = $320,054

Grand Total All Awards = $320,054

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Development of a novel translational pain-drug screening platform for the generation of human-relevant data in preclinical pain drug discovery

Award Number: R43DA052947

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2020

PERIOD OF PERFORMANCE END DATE: 09/29/2022

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