SPARIAN BIOSCIENCES JOINS U.S. SENATE PANEL IN FIGHTING FENTANYL  

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New York, New York – Sparian Biosciences, Inc. (“Sparian”) submitted testimony to the United States Senate Committee on Finance on the fentanyl public health crisis. Sparian, a clinical-stage biopharmaceutical company, is developing novel therapeutics to address the nation’s ongoing fentanyl and substance use disorder (SUD) crisis. One of Sparian’s highest priority programs (SBS-371) is a new therapeutic to reverse fentanyl overdoses.

 

The U.S. Senate Committee on Finance, which has broad jurisdiction over federal health policy programs, held a bipartisan hearing on May 23, 2024 to address the growing number of fentanyl and synthetic opioid-related deaths. These illicit substances have hurt American communities across the country, amounting to nearly 76,000 deaths in 2023, according to the Centers for Disease Control and Prevention.[1]

 

As part of the Committee’s hearing, the panel asked for testimony, also known as statements for the record, from public stakeholders. Given Sparian’s expertise in this field, the company submitted testimony detailing its contributions to combat fentanyl as well as public policy interventions.

 

After submitting the testimony, Sparian Chief Executive Officer and Co-founder, Jeff Reich, M.D., said, “We are grateful for the Committee’s bipartisan efforts to combat fentanyl and are pleased to share our expertise. We would encourage the Committee to continue its longstanding, bipartisan work on this issue, including supporting the NIH’s HEAL Initiative.”

 

Sparian’s statement for the record is pasted below. For inquiries about this release, please contact Sahil Chaudhary at sahil@sparianbiosciences.com

 

The Honorable Ron Wyden

Chairman

Committee on Finance

United States Senate

Washington, DC 20510

 

The Honorable Mike Crapo

Ranking Member

Committee on Finance

United States Senate

Washington, DC 20510

 

Dear Chairman Wyden and Ranking Member Crapo:

 

Sparian Biosciences is grateful for the opportunity to submit a statement for the record for the May 23, 2024 hearing titled, “Front Lines of the Fentanyl Crisis: Supporting Communities and Combating Addiction through Prevention and Treatment.” We commend your leadership and commitment to ending the fentanyl crisis, which is part of the nation’s ongoing substance use disorder (SUD) epidemic.

 

By the way of background, Sparian Biosciences is a clinical stage biopharmaceutical company that is at the forefront of developing novel therapeutics to combat fentanyl. One of Sparian’s highest priority drug programs is a novel therapeutic, dubbed SBS-371, that has the potential to improve how fentanyl overdoses are reversed. In addition, SBS-371 could serve as a prophylactic agent or a bio-shield to protect first responders and law enforcement from bioterror attacks deploying highly potent synthetic opioids like fentanyl.

 

As Chairman Wyden noted in his opening statement, “more needs to be done to head off opioid use in the first place and encourage more non-opioid pain management to be used in American health care.”[2] Sparian could not agree more; Sparian is working tirelessly to develop a non-opioid pain treatment (SBS-1000 and SBS-147) for patients requiring long-term pain management. This therapeutic is a first-in-class AEAr agonist that is currently in Phase 1 clinical trials. Sparian is proud to be working closely with the National Institutes of Health (NIH) and National Institute of Drug Abuse (NIDA) to advance this much-needed alternative to opioids.

 

The collaboration between Sparian and NIH/NIDA is supported by the Helping to End Addiction Long-term (HEAL) Initiative, which currently supports 1,800 prevention, treatment and recovery projects focused on fentanyl and other SUDs. HEAL Initiative funding is distributed across all 50 States.[3] Sparian is grateful for the Committee’s longstanding bipartisan support for HEAL and would encourage the Committee to continue this support as it represents one of the federal government’s largest commitments to addressing fentanyl.

 

Sparian is also greatly appreciative of the leadership of Chairman Wyden and Ranking Member Crapo to enact bipartisan legislation that will expand access to medication-assisted treatment (MAT).[4],[5] As Chairman Wyden said in his opening statement, MAT “is the gold standard treatment for opioid use disorder.”[6] Sparian concurs with this is sentiment and is expeditiously advancing, SBS-226, which would provide clinicians with a new pharmacological treatment alongside buprenorphine and methadone to use in MAT.

 

As Ranking Member Crapo said in his opening remarks, the country needs “targeted policies that can make a difference and address the root causes of the fentanyl crisis.”[7] Sparian strongly support this position and would add that these targeted policies should involve interdisciplinary approaches. To ensure appropriate use of federal resources on targeted policies, Sparian would encourage the Committee to support a whole-of-government initiative to tackle fentanyl that is modeled after best practices from the bipartisan Operation Warp Speed initiative. This collaborative approach would elevate the urgency of the fentanyl crisis, pool public and private expertise as well as avoid duplication of federal programs and resources.

 

Sparian would also urge the Committee to consider making targeted investments in bolstering the nation’s SUD workforce. As the Committee knows well from the work of its Bipartisan Medicare GME Working Group, the U.S. has looming shortages of crucial healthcare roles.[8] The nation’s SUD workforce, however, is already experiencing such shortages, which will only get worse. The American Society of Addiction Medicine, for instance, recently found the U.S. has about 4,400 physicians certified in addiction medicine, but this falls short of 6,000 currently needed.[9] These shortages disproportionately affect medically underserved and rural communities. To alleviate these SUD workforce challenges, Sparian would encourage the Committee to direct Medicare to set-aside additional residency slots for addiction medicine, expand the National Health Service Corp’s SUD loan repayment program, among other initiatives.

 

Thank you for the opportunity to share Sparian’s perspective. Sparian Biosciences shares your mission of ending the fentanyl crisis that has claimed far too many lives and hurt millions of American families from every walk of life.

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[1] List of Public Health Emergency Declarations (hhs.gov)

[2] 0523_wyden_statement.pdf (senate.gov)

[3] NIH Heal Initiative 2024 Annual Report: Research in Action

[4] 0523_crapo_statement.pdf (senate.gov)

[5] 0523_crapo_statement.pdf (senate.gov)

[6] 0523_wyden_statement.pdf (senate.gov) 

[7] 0523_crapo_statement.pdf (senate.gov)

[8] GME Outline (senate.gov)

[9] asam-training-demo-one-pagerb1ff289472bc604ca5b7ff000030b21a.pdf

SPARIAN BIOSCIENCES URGES U.S. SENATE TO SUPPORT NIH’S AGAINST FIGHT SUBSTANCE ABUSE 

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New York, New York–Sparian Biosciences, Inc. (“Sparian”) submitted testimony on May 23, 2024, urging the United States Senate to provide the National Institutes of Health (NIH) with the resources to combat the substance abuse epidemic, which claimed 107,543 American lives in 2023.[1]

 

Sparian Biosciences is a clinical stage biopharmaceutical company at the forefront of developing innovative treatments to end this public health crisis. Sparian currently has four leading drug development programs for substance use disorders (SUD) and non-opioid based pain management. First off, Sparian’s AEAr agonists (SBS-1000 and SBS-147) are first-in-class drug candidates that offer an alternative to opioids for long-term pain management. Sparian’s second program (SBS-226) is a pre-clinical drug candidate that has potential to treat opioid use disorders, which if successful, would provide clinicians with a new pharmacological treatment alongside buprenorphine and methadone. Sparian is also developing a third drug candidate (SBS-371) that has the potential to revolutionize how first responders reverse drug overdoses from fentanyl and other powerful synthetic opioids. Lastly, Sparian is addressing a critical unmet need in the SUD space; the company is developing a therapeutic (SBS-518) for stimulant use disorders to help those seeking treatment for illicit drug use such as methamphetamine and cocaine.

 

Sparian stands apart from other biotechs for its prodigious collaboration with NIH. This public-private partnership has helped advance new non-opioid pain management therapies (SBS-1000 and SBS-147), a novel drug for use in medication-assisted treatment (SBS-226), and a new stimulant use disorder medication (SBS-518). NIH has been able to support Sparian’s lifesaving research through its Helping to End Addiction Long-Term (HEAL) Initiative.

 

The HEAL Initiative supports nearly 1,800 SUD prevention, treatment and recovery programs across all 50 States. NIH’s HEAL Initiative has historically received strong bipartisan support from congressional lawmakers.

 

To that end, Sparian submitted testimony to the U.S. Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies—the Senate panel responsible for NIH’s budget—urging it to continue its longstanding support for the lifesaving HEAL Initiative. Sparian also encouraged the panel to direct NIH’s newest agency, the Advanced Research Project Agency for Health (ARPA-H), to include SUD projects in its mission given the SUD crisis deleterious effects on American communities.

 

Sparian’s testimony is provided below. For inquiries about this release, please contact Sahil Chaudhary at sahil@sparianbiosciences.com

 

The Honorable Tammy Baldwin

Chairwoman

Subcommittee on Labor, Health and Human Services, and Related Agencies

Committee on Appropriations

United States Senate

Washington, DC 20510

 

The Honorable Shelly Moore Capito

Ranking Member

Subcommittee on Labor, Health and Human Services, and Related Agencies

Committee on Appropriations

United States Senate

Washington, DC 20510

 

Dear Chairwoman Baldwin and Ranking Member Moore Capito:

 

Sparian Biosciences is grateful for the opportunity to comment on the President’s Fiscal Year (FY) 2025 budget proposal for the National Institutes of Health (NIH), an agency that is at the forefront of addressing the substance use disorder (SUD) epidemic.

 

By the way of background, Sparian Biosciences is a clinical stage biopharmaceutical company that is developing four novel therapeutics to address drug abuse and chronic pain. Sparian’s AEAr agonists (SBS-1000 and SBS-147) are first-in-class drug candidates that offer a non-opioid treatment for patients requiring long-term pain management. The company’s second program (SBS-226) is a pre-clinical drug candidate that has potential to treat opioid use disorders, which if successful, would provide clinicians with a new pharmacological treatment alongside buprenorphine and methadone. Sparian is also developing a third drug candidate (SBS-371) that has the potential to revolutionize how first responders reverse drug overdoses from fentanyl and other powerful synthetic opioids. Lastly, Sparian is addressing a critical unmet need in the SUD space; the company is developing a therapeutic (SBS-518) for stimulant use disorders to help those seeking treatment for illicit drug use such as methamphetamine and cocaine. Sparian is working hand-and-glove with NIH to expeditiously develop these lifesaving treatments that will end the SUD epidemic, which claimed 107,543 American lives in 2023.[2]

 

To that end, we respectfully request that you consider the following appropriations requests that will provide NIH with the tools and resources to continue its fight against the SUD public health crisis:

 

1. Increase funding for NIH’s Helping to End Addiction Long-Term (HEAL) Initiative: The HEAL Initiative is one of the federal government’s largest commitments to address the SUD crisis. This multi-faceted program supports nearly 1,800 projects across all 50 States, including your home States of Wisconsin and West Virginia. As of NIH’s most recent funding data, Wisconsin has received nearly 11 HEAL grants to support research into new SUD treatments and West Virginia has received 4 HEAL grants to build SUD prevention and treatment capabilities.[3] The President’s budget calls for flat funding for the NIH HEAL Initiative, which given the U.S.’ healthcare inflation rate of nearly 3%, amounts to a funding cut in real terms. Should this cut be enacted, it could hamper the ability of clinicians, advocates, researchers, among other frontline workers to continue their efforts to prevent and treat SUDs.

 

1. Encourage ARPA-H to prioritize programs focused on preventing and treating SUDs: The Advanced Research Projects Agency for Health (ARPA-H) has the potential to catalyze research in disease areas that exact a significant human and financial toll on Americans. Despite a current Public Health Emergency declaration for the SUD crisis,[4] ARPA-H has not mobilized resources to accelerate innovations in this space. We urge you to add appropriations language directing the agency to formulate a grant strategy to provide resources to scientists and researchers developing novel therapeutics to address SUDs.

 

Thank you for your consideration of these requests and your public health leadership. Sparian Biosciences shares your mission of ending the SUD public health crisis that has claimed far too many lives and hurt millions of American families from every walk of life.

 

[1] U.S. Overdose Deaths Decrease in 2023, First Time Since 2018 (cdc.gov)

[2] U.S. Overdose Deaths Decrease in 2023, First Time Since 2018 (cdc.gov)

[3] Funded Projects | NIH HEAL Initiative

[4] List of Public Health Emergency Declarations (hhs.gov)

 

Sparian Biosciences Awarded $19 Million Five-Year NIH/NIDA Grant to Fund Development of SBS-518 for Stimulant Use Disorder Through Phase 1 Clinical Development

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• SBS-518 is a dual sigma receptor antagonist/dopamine active transporter inhibitor in development for the treatment of stimulant use disorder (e.g., cocaine and methamphetamine)

• Grant awarded by National Institutes of Health / National Institute of Drug Abuse (NIH/NIDA) under the Help End Addiction Long-Term (HEAL) initiative

 

NEW YORK, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Sparian Biosciences, Inc.(“Sparian”), a clinical-stage CNS-focused biopharmaceutical company, today announced that it has been awarded a $19 million, five-year grant to fund development of SBS-518 from IND submission through Phase 1 clinical development. SBS-518 is a first-in-class dual sigma receptor (SR)antagonist/dopamine transporter (DAT) inhibitor in development for the treatment of stimulant use disorder (StUD). StUD is a subset of substance use disorders that includes cocaine and methamphetamine use disorders. The grant was awarded by NIH/NIDA under the Help End Addiction Long-Term (HEAL) initiative.
SBS-518 is a novel first-in-class compound that targets within the brain both the sigma receptor (S1 and S2) and the dopamine active transporter (DAT). In pre-clinical efficacy assays, SBS-518 blocks the stimulant induced rise in extra-cellular dopamine and blocks cocaine and methamphetamine self-administration without itself producing self-rewarding behavior. DAT, the site of action for stimulants, including illicit stimulants, has proven to be an elusive target for therapeutics. The combination of sigma and DAT inhibition appears to block the action of methamphetamine and cocaine without interfering with the physiologic transport of dopamine.

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“Sparian was founded to develop innovative therapeutics to treat CNS disorders, particularly pain and substance use disorders,” said Jeff Reich, M.D., Chief Executive Officer and Co-founder. “StUD presents a major unmet medical and public health need for which there are currently no approved therapies. If we can successfully advance SBS-518 into the clinic, it could represent a significant step forward in the treatment of substance use disorders.”
The $19 million dollars in funding represents the third NIH/NIDA grant Sparian has received. Since its founding, Sparian has been awarded a total of $41 million in government grants to support three programs. The lead program SBS1000, a non-opioid analgesic, is now in phase 1 clinical trials. SBS-226, a dual mu opioid receptor(MOR) agonist/delta opioid receptor (DOR) antagonist, is being developed for opioid use disorder (OUD).

“We are extremely proud of the ongoing support we have received from NIDA,” said Dr. Reich. “NIDA, through the HEAL initiative, has sparked a new wave of innovation and entrepreneurship dedicated to the treatment of substance use disorders. Sparian, along with our academic partners, is honored to be a trusted collaborator.”

SBS-518 is being developed in collaboration with the National Institute of Drug Abuse (NIDA), University of Florida College of Pharmacy, and the Harvard Medical School-McLean Hospital.

About Stimulant Use Disorder (StUD)

StUD represents a serious public health crisis in the U.S. with a growing prevalence of 4.1 million and approximately 57,000 annual deaths reported in 2021. There are no U.S. Food and Drug Administration-approved drugs to treat StUD. The current treatment approach includes off-label use of prescription therapies, such as antidepressants, and/or behavioral-psychosocial modalities. Only modest benefits have been demonstrated. It is estimated that only 13% of eligible patients are undergoing treatment of any kind reflecting the lack of effective medication.

About Sparian Biosciences
Sparian Biosciences is a clinical-stage CNS-focused biopharmaceutical company committed to developing transformational therapies to address significant medical needs. The company was co-founded by Jeff Reich, M.D., and Gavril Pasternak, M.D., Ph.D., and was spun out of Memorial Sloan Kettering Cancer Center (MSK). Sparian has five programs that address acute and chronic pain, opioid use disorder (OUD),acute opioid overdose, and stimulant use disorder (StUD). Sparian is the recipient of two NIDA UG3/UH3 grants and an SBIR grant totaling nearly $41M in NIH support. For more information, visit www.Sparianbiosciences.com

 

Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under award number1UG3DA058553-01.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health

Sparian Biosciences Announces Initiation of Phase 1 Clinical Trial of First-In-Class Arylepoxamide Agonist, SBS-1000, for the Treatment of Pain 

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• SBS-1000 is the first arylepoxamide agonist for the treatment of pain to receive IND clearance

• Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, and analgesic efficacy of SBS-1000 

• SBS-1000 may present an alternative to opioids for the treatment of pain

 

NEW YORK, NY,  February 23, 2023 -- Sparian Biosciences, Inc., a clinical-stage CNS-focused biopharmaceutical company, today announced the initiation of a phase 1 clinical trial of SBS-1000, its first-in-class arylepoxamide receptor (AEAr) agonist. SBS-1000 is the first AEAr agonist to receive IND clearance from the FDA and to proceed to a phase 1 human clinical study.
SBS-1000 targets the newly discovered AEA receptor (AEAr) in the pain pathway. In preclinical efficacy studies, SBS-1000 demonstrates potent analgesia in nociceptive, neuropathic, and inflammatory pain models. In addition, in preclinical safety studies, SBS-1000 does not demonstrate respiratory depression, physical dependence, or abuse liability compared to morphine. 
“Effective pain management remains a significant challenge across medical and surgical conditions, and SBS-1000 has the potential to replace opioids for the treatment of acute and chronic pain. In the face of the ongoing opiate crisis, we believe SBS-1000 could represent a fundamental and critically needed innovation,” said Jeffrey B. Reich, MD, Chief Executive Officer, Sparian Biosciences. “We have been eager to start the  phase 1 trial and hope that the promising preclinical profile of SBS-1000 will translate to human studies.”

The phase 1 clinical trial will primarily evaluate the safety, tolerability, and pharmacokinetics of SBS-1000.  In addition, the compound’s analgesic efficacy will be assessed using the Cold Pressor Test as an exploratory endpoint. More details about the trial design are available on www.clinicaltrials.gov.

About Sparian Biosciences
Sparian Biosciences is a clinical-stage CNS-focused biopharmaceutical company committed to developing transformational therapies to address significant medical needs. The company was co-founded by  Jeff Reich, MD, and Gavril Pasternak, MD, PhD, and was spun out of Memorial Sloan Kettering Cancer Center (MSKCC). Sparian has five programs that address acute and chronic pain, opioid use disorder, acute opioid overdose, and stimulant use disorder. Sparian is the recipient of two NIH/ NIDA grants worth nearly $20 million. For more information, visit www.Sparianbiosciences.com. 

Sparian Biosciences Announces IND Clearance of First-In-Class Arylepoxamide Agonist, SBS-1000, for the Treatment of Pain by the U.S. FDA

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• SBS-1000 is the first arylepoxamide agonist for the treatment of pain to receive IND clearance

• Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and analgesic efficacy of SBS-1000 will begin in 1Q2023

• SBS-1000 may present an alternative to opioids for the treatment of pain

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NEW YORK, NY,  February 9, 2023 -- Sparian Biosciences, Inc., a clinical-stage CNS-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to commence a phase 1 clinical trial of its first-in-class arylepoxamide receptor (AEAr) agonist, SBS-1000, for the treatment of pain. SBS-1000 is the first AEAr agonist to receive IND clearance from the FDA.

SBS-1000 targets the newly discovered AEA receptor (AEAr) in the pain pathway. In preclinical efficacy studies, SBS-1000 demonstrates potent analgesia in nociceptive, neuropathic, and inflammatory pain models. In preclinical safety studies, SBS-1000 does not demonstrate respiratory depression, physical dependence, or abuse liability as compared to morphine.

“The characterization of the AEAr and the development of arylepoxamide agonists represent a major new innovation in field of pain research,” said Jeffrey B. Reich, MD, Chief Executive Officer, Sparian Biosciences. “Our success so far has been the result of a productive collaboration with NIH/NIDA and we look forward to  the start of our phase 1 trial.”

The phase 1 clinical trial will primarily evaluate the safety, tolerability, and pharmacokinetics of SBS-1000.  In addition, the compound’s analgesic efficacy will be assessed using the Cold Pressor Test as an exploratory endpoint. More details about the trial design are available on www.clinicaltrials.gov.

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About Sparian Biosciences

Sparian Biosciences is a clinical-stage CNS-focused biopharmaceutical company committed to developing transformational therapies to address significant medical needs. The company was co-founded by  Jeff Reich, MD, and Gavril Pasternak, MD, PhD, and was spun out of Memorial Sloan Kettering Cancer Center (MSKCC).   Sparian has five programs that address acute and chronic pain, opioid use disorder, acute opioid overdose, and stimulant use disorder. Sparian is the recipient of two NIH/ NIDA grants worth nearly $20 million.