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IND-enabling studies on novel Cav3 T-channel modulators for treatment of neuropathic pain

Award Number: R44NS086343
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2014
PERIOD OF PERFORMANCE END DATE: 01/31/2023

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IND-enabling studies on novel Cav3 T-channel modulators for treatment of neuropathic pain - 7. PROJECT SUMMARY Neuropathic pain remains a poorly managed medical condition affecting more than 1.5 billion people worldwide. Over 20 million people suffered from diabetic neuropathy and neuropathic pain in the US alone in 2015. The current standard of care is insufficient. Topical applications and systemic treatment with existing analgesics, including opioids, leave millions suffering. More than 50% of these patients are refractory to medication. Opioids frequently cause devastating side effects, and overdose has claimed 300,000 lives in the United States since 2000. The lack of effective analgesics for chronic pain has contributed to the opioid crisis. To address this National Health Emergency, we at AfaSci Research Laboratories have discovered non-opioid new class of compounds to treat neuropathic pain with the SBIR Fast-Track grant support. Our compounds possess much greater potency and selectivity to modulate the T-type Cav3.2 channel than all currently known T-channel inhibitors. Rigorous in vivo pharmacokinetic and pharmacodynamic (PK/PD) studies and preliminary toxicological studies have provided valuable scientific insights that enabled AfaSci to select AFA-279, along with several backup candidates, for the IND-enabling studies proposed in this SBIR Phase IIB project. At their efficacious doses, our new compounds did not produce observable side-effects frequently experienced with existing pain therapeutics. We have conducted multiple tests comparing the effectiveness of these new compounds against a current neuropathic pain medication, gabapentin. Our compounds showed greater analgesic effects than gabapentin in multiple rodent neuropathic pain models. The goal of this proposed SBIR Phase IIB project is to submit the IND application on our Cav3.2 modulator to the Food and Drug Administration (FDA). To achieve this goal, three Specific Aims must be accomplished: 1) produce AFA-279 under Good Manufacturing Practice (GMP)-like conditions using chemical manufacturing controls (CMC) for GLP nonclinical toxicity studies and GMP clinical batch future Phase 1 clinical trials, 2) complete toxicological and safety studies under Good Laboratory Practice (GLP) to establish the safety profile of AFA-279 and 3) prepare and submit the IND application for our novel T-channel modulator to the FDA. Our investigative team (PI Dr. Xie, Chemist Dr. Kayser, Pharmacologist Dr. Zou, and Project Manager Dr. Greene) with consultants (Toxicologist Dr. Tepper and Statistician Dr. Yang), and our Scientific Advisors will collaborate with Stanford Medical School and contract research organizations (Regis Technologies, Charles River Laboratories and AnaBios) to ensure successful completion of this exciting project. Success in this project will lead to a successful FDA IND filing of our Cav3.2 modulator. We will then initiate early clinical trials on our novel T-channel modulator with our strategic partners, Cavion and/or Biohaven. Our ultimate goal is to deliver a safer, more effective, non-opioid Cav3.2 channel modulator to patients suffering from neuropathic pain and to help address the opioid epidemic by providing effective non-addictive analgesics.


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: 2024 ( Subtotal = $0 )
2024	2020	AFASCI, INC.	2633 MARTINEZ DR	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	1/9/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	AFASCI, INC.	2633 MARTINEZ DR	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	5/18/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1,491,584 )
2020	2020	AFASCI, INC.	2633 MARTINEZ DR	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	5	8/20/2020	NON-COMPETING CONTINUATION	$1,491,584
2020	2018	AFASCI, INC.	2633 MARTINEZ DR	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	3/18/2020	COMPETING CONTINUATION	$0
														Subtotal = $1,491,584

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	AFASCI, INC.	2633 MARTINEZ DR	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	4	7/17/2019	COMPETING CONTINUATION	$0
2019	2016	AFASCI, INC.	2633 MARTINEZ DR	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	12/14/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $1,491,977 )
2018	2018	AFASCI, INC.	2633 MARTINEZ DR	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	4	9/15/2018	COMPETING CONTINUATION	$1,491,977
2018	2016	AFASCI, INC.	2633 MARTINEZ DR	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	3	9/17/2018	NON-COMPETING CONTINUATION	$0
2018	2016	AFASCI, INC.	2633 MARTINEZ DR	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	6/27/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,491,977

Issue Date FY: 2017 ( Subtotal = $2 )
2017	2014	AFASCI, INC.	2633 MARTINEZ DR	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	7/20/2017	NEW	-$2
2017	2014	AFASCI, INC.	2633 MARTINEZ DR	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	1	9/18/2017	SUPPLEMENT FOR EXPANSION	$0
2017	2014	AFASCI, INC.	2633 MARTINEZ DR	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	1	9/18/2017	NEW	$2
2017	2014	AFASCI, INC.	2633 MARTINEZ DR	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	7/20/2017	SUPPLEMENT FOR EXPANSION	$2
														Subtotal = $2

Issue Date FY: 2016 ( Subtotal = $741,690 )
2016	2016	AFASCI INC	2633 MARTINEZ DRIVE	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	7/27/2016	NON-COMPETING CONTINUATION	$741,690
														Subtotal = $741,690

Issue Date FY: 2015 ( Subtotal = $690,517 )
2015	2015	AFASCI INC	2633 MARTINEZ DRIVE	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	9/10/2015	EXTENSION WITH OR WITHOUT FUNDS	$690,517
														Subtotal = $690,517

Issue Date FY: 2014 ( Subtotal = $249,999 )
2014	2014	AFASCI INC	2633 MARTINEZ DRIVE	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	6/27/2014	NEW	$224,999
2014	2014	AFASCI INC	2633 MARTINEZ DRIVE	BURLINGAME	CA	94010	SAN MATEO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	9/9/2014	SUPPLEMENT FOR EXPANSION	$25,000
														Subtotal = $249,999

Grand Total All Awards = $4,665,769

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IND-enabling studies on novel Cav3 T-channel modulators for treatment of neuropathic pain

Award Number: R44NS086343

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/01/2014

PERIOD OF PERFORMANCE END DATE: 01/31/2023

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