Friday, November 22, 2024 11/22/2024

Optimization and testing of anti-methamphetamine antibody therapy to support pivotal clinical trials and commercialization

Award Number: U01DA051078
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By:

View Award Abstract

InterveXion is developing an anti-methamphetamine (METH) monoclonal antibody called IXT-m200 for the treatment of METH use disorders. Single doses of IXT-m200 have been well-tolerated in healthy volunteers and also METH users who are given weekly doses of METH (30 mg, IV) following IXT-m200 administration. Importantly, an interim analysis of our ongoing Phase 2 study shows that IXT-m200 alters METH distribution in humans as predicted from nonclinical data, specifically by greatly reducing METH volume of distribution, i.e., sequestering METH in the blood. No serious adverse events or adverse event greater than mild or moderate have been reported in the Phase 2 study. The currently proposed long-term nonclinical studies will facilitate multiple dose clinical trials to test IXT-m200 for efficacy in reducing METH use. In addition, InterveXion will improve the manufacturing process for IXT- m200 and thereby comply with new regulations that have been imposed since the IXT-m200 development program began. Finally, subcutaneous administration of IXT-m200 will be explored as a potential improvement to the dosing regimen. Subcutaneous injections may be given in an office or counseling setting, would allow patients to more easily receive IXT-m200, and should improve medication compliance. The major goal of this proposal is to move IXT-m200 to the next milestone in the FDA approval process, which is multiple dose studies in humans, such as pivotal Phase 2b/3 studies. The specific aims that will allow this goal to be met are as follows. Aim 1: Manufacture IXT-m200 to support required nonclinical and clinical studies. A single cell will be isolated and used to generate a new Master Cell Bank with improved production capabilities. Two batches will be made to provide material for Aim 2 and upcoming clinical trials. Aim 2: Complete multiple dose studies of IXT-m200 in rats to support multiple dose administration in humans. A 6-month toxicology study with 27 weekly doses of IXT-m200 in rats will be done following the successful completion of a pilot study. Aim 3: Conduct studies to determine the feasibility of subcutaneous administration of IXT-m200. IXT-m200 will be concentrated to at least 140 mg/mL and given to rats by subcutaneous injection. Antibody pharmacokinetics, METH binding capability and immunogenicity will be tested. Aim 4: Prepare for first multiple dose clinical study by communicating with FDA, maintaining the IND, and developing a full clinical protocol. All regulatory interactions and requirements will be completed under this aim so that a multiple dose clinical trial may begin as soon as this work is completed. The treatment of METH use disorder remains an unmet medical need with no medications yet approved by the US FDA. InterveXion continues to strive to meet this need by pushing forward quickly with the development of the first METH-binding mAb, IXT-m200. These studies are the next steps toward meeting that need.


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 = -$344,771 )
2024	2022	INTERVEXION THERAPEUTICS LLC	4301 W MARKHAM ST # 831	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	000	3	7/8/2024	NON-COMPETING CONTINUATION	-$344,771
														Subtotal = -$344,771

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	INTERVEXION THERAPEUTICS, LLC.	401 S CEDAR ST	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	001	3	6/30/2023	NON-COMPETING CONTINUATION	$0
2023	2022	INTERVEXION THERAPEUTICS, LLC.	401 S CEDAR ST	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	000	3	2/9/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $2,115,968 )
2022	2022	INTERVEXION THERAPEUTICS, LLC.	401 S CEDAR ST	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	001	3	3/30/2022	NON-COMPETING CONTINUATION	$211,598
2022	2022	INTERVEXION THERAPEUTICS, LLC.	401 S CEDAR ST	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Use and Addiction Research Programs	000	3	2/25/2022	NON-COMPETING CONTINUATION	$1,904,370
														Subtotal = $2,115,968

Issue Date FY: 2021 ( Subtotal = $3,165,675 )
2021	2021	INTERVEXION THERAPEUTICS, LLC.	4301 W MARKHAM #831	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Abuse and Addiction Research Programs	000	2	3/1/2021	NON-COMPETING CONTINUATION	$3,165,675
														Subtotal = $3,165,675

Issue Date FY: 2020 ( Subtotal = $3,136,427 )
2020	2020	INTERVEXION THERAPEUTICS, LLC.	4301 W MARKHAM #831	LITTLE ROCK	AR	72205	PULASKI	USA	Drug Abuse and Addiction Research Programs	000	1	4/29/2020	NEW	$3,136,427
														Subtotal = $3,136,427

Grand Total All Awards = $8,073,299

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Optimization and testing of anti-methamphetamine antibody therapy to support pivotal clinical trials and commercialization

Award Number: U01DA051078

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer