Trending...
- Allstream Energy Partners Nominated in Multiple Categories for Fast Company's Best Workplaces for Innovators
- Garage door installation or repair in Minnesota? Which makes more sense for your family?
- Congressman Chuck Edwards (NC-11) Presents ReadyCommunities Partnership 2026 National Service Award to Local Businessman / US Air Force Veteran
PHILADELPHIA--(BUSINESS WIRE)--SwanBio Therapeutics, a gene therapy company advancing AAV-based therapies for the treatment of devastating, inherited neurological conditions, today presented details about the company's ongoing natural history study of adrenomyeloneuropathy (AMN) at the 8th Congress of the European Academy of Neurology (EAN) in Vienna. The intention of the CYGNET study is to assess disease progression in patients with AMN to inform the research and development of potential treatments, including SwanBio's lead candidate, SBT101, the first clinical-stage AAV-based gene therapy for AMN.
"At SwanBio, our approach to drug development begins with deepening our understanding of the origin and trajectory of diseases like AMN, ideally enabling us to deliver gene therapies that are both highly effective and meaningful for the quality of life of patients. With this in mind, our proprietary CYGNET study was designed to better characterize AMN disease progression, which varies from person to person," said Steven Zelenkofske, D.O., chief medical officer, SwanBio Therapeutics. "CYGNET is the first AMN clinical study to feature wearables, which may help us identify sensitive outcomes related to clinically relevant changes early in men with AMN."
SwanBio's CYGNET natural history study will track a number of variables over a two-year period, including:
More details about the CYGNET study, including demographics and disease characteristics of the first 21 patients enrolled, were presented during a virtual poster session at EAN.
More on The PennZone
SwanBio anticipates recruiting approximately 80 patients for the CYGNET natural history study; as of early June, the study was over 40% enrolled across five different global sites. Clinicians or patients interested in learning more about this study can review SwanBio's CYGNET flyer or contact SwanBio at clinicaltrials@swanbiotx.com.
Presentation Details
ePoster EPO-599: CYGNET: A prospective multicenter observational study of disease progression in patients with adrenomyeloneuropathy
Date & Time: June 27, 2022, 12:30 – 1:15 p.m. CEST
About SBT101
SBT101 is the first clinical-stage adeno-associated virus (AAV)-based gene therapy candidate for people with adrenomyeloneuropathy (AMN). SBT101 was designed to compensate for the disease-causing ABCD1 mutation. In preclinical studies, treatment with SBT101 demonstrated dose-dependent improvement of disease markers and functional improvement in AMN mouse models. SBT101 was also shown to be well-tolerated in non-human primates at six months post-treatment. The clinical program for SBT101 builds on this positive preclinical data, plus the company's already deep understanding of the underlying pathophysiology of the disease and the patient experience of AMN.
SwanBio expects to initiate a randomized, controlled Phase 1/2 clinical trial designed to assess the safety and efficacy of SBT101 in patients with AMN in the second half of 2022. In early 2022, the FDA cleared SwanBio's Investigational New Drug application for SBT101 and granted SBT101 Fast Track and Orphan Drug Designation.
More on The PennZone
About Adrenomyeloneuropathy
Adrenomyeloneuropathy (AMN) is a progressive and debilitating neurodegenerative disease caused by mutations in the ABCD1 gene that disrupt the function of spinal cord cells and other tissues. AMN is characterized by loss of mobility in adulthood, incontinence, pain, and sexual dysfunction, which all affect quality of life. Between 8,000-10,000 men in the United States and European Union are living with AMN. There are no approved therapies for the treatment of the disease; current standard of care is limited to symptom management.
About SwanBio Therapeutics
SwanBio Therapeutics is a gene therapy company that aims to bring life-changing treatments to people with devastating, inherited neurological conditions. SwanBio is advancing a pipeline of gene therapies, designed to be delivered intrathecally, that can address targets within both the central and peripheral nervous systems. This approach has the potential to be applied broadly across three disease classifications – spastic paraplegias, monogenic neuropathies, and polygenic neuropathies. SwanBio's lead program is being advanced toward clinical development for the treatment of adrenomyeloneuropathy (AMN). SwanBio is supported by long-term, committed investment partners, including its primary investors Syncona, Ltd. (lead investor and majority shareholder) and Mass General Brigham Ventures. For more information, visit SwanBioTx.com.
References
Contacts
Media Contact:
Lara Furst
+1-703-946-0183
media@swanbiotx.com
Investor Contact:
Chelcie Lister
+1-910-777-3049
investors@swanbiotx.com
Patient and Physician Inquiries:
clinicaltrials@swanbiotx.com
"At SwanBio, our approach to drug development begins with deepening our understanding of the origin and trajectory of diseases like AMN, ideally enabling us to deliver gene therapies that are both highly effective and meaningful for the quality of life of patients. With this in mind, our proprietary CYGNET study was designed to better characterize AMN disease progression, which varies from person to person," said Steven Zelenkofske, D.O., chief medical officer, SwanBio Therapeutics. "CYGNET is the first AMN clinical study to feature wearables, which may help us identify sensitive outcomes related to clinically relevant changes early in men with AMN."
SwanBio's CYGNET natural history study will track a number of variables over a two-year period, including:
- Body sway, which has been shown to be an early predictor of disease progression and likelihood of falls in AMN, even in asymptomatic patients.1
- Both traditional motor tasks and novel activity and sleep outcomes, using wearable technology.
- Quality of life and several disease severity and functional impairment measures.
More details about the CYGNET study, including demographics and disease characteristics of the first 21 patients enrolled, were presented during a virtual poster session at EAN.
More on The PennZone
- Put Your Herd on Your Phone: Kiko Nation Makes Livestock Management Simple
- Future Intelligence Think Tank Surpasses 1,000 Members Exploring Human and Artificial Intelligence
- Gary Bernstein Expands Media Leadership Role With Senior Strategic Advisor Appointment To Blacksun Private Equity
- Headline: House of Nova Paints Every Face in Gold at New York Fashion Week
- Can Government Operate Better Through Innovation?
SwanBio anticipates recruiting approximately 80 patients for the CYGNET natural history study; as of early June, the study was over 40% enrolled across five different global sites. Clinicians or patients interested in learning more about this study can review SwanBio's CYGNET flyer or contact SwanBio at clinicaltrials@swanbiotx.com.
Presentation Details
ePoster EPO-599: CYGNET: A prospective multicenter observational study of disease progression in patients with adrenomyeloneuropathy
Date & Time: June 27, 2022, 12:30 – 1:15 p.m. CEST
About SBT101
SBT101 is the first clinical-stage adeno-associated virus (AAV)-based gene therapy candidate for people with adrenomyeloneuropathy (AMN). SBT101 was designed to compensate for the disease-causing ABCD1 mutation. In preclinical studies, treatment with SBT101 demonstrated dose-dependent improvement of disease markers and functional improvement in AMN mouse models. SBT101 was also shown to be well-tolerated in non-human primates at six months post-treatment. The clinical program for SBT101 builds on this positive preclinical data, plus the company's already deep understanding of the underlying pathophysiology of the disease and the patient experience of AMN.
SwanBio expects to initiate a randomized, controlled Phase 1/2 clinical trial designed to assess the safety and efficacy of SBT101 in patients with AMN in the second half of 2022. In early 2022, the FDA cleared SwanBio's Investigational New Drug application for SBT101 and granted SBT101 Fast Track and Orphan Drug Designation.
More on The PennZone
- Michael H. Kaplan Advocates for Seriously Injured Colorado Workers Who Need In-Home Care
- Her Song Lives On: Remembering Mrs. Darlene Davis Porter
- Infinity Infusion Solutions Named Finalist for D Magazine's D CEO 2026 Excellence in Healthcare Awards
- Pittsburgh Creators Launch Clever New Children's Book, "The Sock Sleuth!"
- Canadian Tint Expo 2027: Why Every Window Tinter Should Compete in Niagara Falls on April 3rd & 4th
About Adrenomyeloneuropathy
Adrenomyeloneuropathy (AMN) is a progressive and debilitating neurodegenerative disease caused by mutations in the ABCD1 gene that disrupt the function of spinal cord cells and other tissues. AMN is characterized by loss of mobility in adulthood, incontinence, pain, and sexual dysfunction, which all affect quality of life. Between 8,000-10,000 men in the United States and European Union are living with AMN. There are no approved therapies for the treatment of the disease; current standard of care is limited to symptom management.
About SwanBio Therapeutics
SwanBio Therapeutics is a gene therapy company that aims to bring life-changing treatments to people with devastating, inherited neurological conditions. SwanBio is advancing a pipeline of gene therapies, designed to be delivered intrathecally, that can address targets within both the central and peripheral nervous systems. This approach has the potential to be applied broadly across three disease classifications – spastic paraplegias, monogenic neuropathies, and polygenic neuropathies. SwanBio's lead program is being advanced toward clinical development for the treatment of adrenomyeloneuropathy (AMN). SwanBio is supported by long-term, committed investment partners, including its primary investors Syncona, Ltd. (lead investor and majority shareholder) and Mass General Brigham Ventures. For more information, visit SwanBioTx.com.
References
- van Ballegoij WJC, van de Stadt SIW, Huffnagel IC, Kemp S, van der Knaap MS, Engelen M. Postural Body Sway as Surrogate Outcome for Myelopathy in Adrenoleukodystrophy. Front Physiol. 2020;11:786.
Contacts
Media Contact:
Lara Furst
+1-703-946-0183
media@swanbiotx.com
Investor Contact:
Chelcie Lister
+1-910-777-3049
investors@swanbiotx.com
Patient and Physician Inquiries:
clinicaltrials@swanbiotx.com
0 Comments
Latest on The PennZone
- Scoop Social Co. Brings Its Signature Mobile Dessert Experience to Houston This October
- The Social Capital Revolution Comes to Phoenix!
- Lawsuit Alleges American Deli Food Caused Severe Illness, Acute Kidney Failure, And Eight-day Hospitalization
- FBI/DoW plot uncovered to hurt Trump/Vance through encouraged "widespread" cybersecurity breaches and racketeering theft of $80m in USDA payments
- Bettingbladet releases H1 2026 report on the Swedish online gambling market
- Garage door installation or repair in Minnesota? Which makes more sense for your family?
- SMACK Fight Week Takes Over Philadelphia
- Super Rooter Expands to 190 Plumbing, Sewer, and Drain Service Locations Across the United States
- European Patent for ALS Program Expands the Story: HOPE Deploys Robotic TMS & FDA Commercialization Path Advances: NRx Pharmaceuticals: NAS DAQ: NRXP
- VICTURY Sports Announces Formation of Youth Sports League Built on the Official, Patented, and Award-Winning Keepy Uppy® Ball
- Spearmint Publishes Full Design of Its Mining Pool Before Building It, Including Legal Drafts
- Congressman Chuck Edwards (NC-11) Presents ReadyCommunities Partnership 2026 National Service Award to Local Businessman / US Air Force Veteran
- Cress Creeks Farm Opens Fall Corn Maze and Baby Lamb Hayride Experience in Ellijay, Georgia
- Brewtay Coffee Introduces Specialty Instant Line Designed for High-Velocity Commuters and Travelers
- Allstream Energy Partners Nominated in Multiple Categories for Fast Company's Best Workplaces for Innovators
- Ten Ten Ten Awards Provisional Certification to Cara AI for Home-Based Health Assessments
- IDI Consulting Partners with the American Heart Association to Advance Heart Health Awareness
- Kerri Lawless Introduces New Home-Selling Option for Local Homeowners
- Bethany Nikitenko Appointed to Philadelphia Trial Lawyers Association Diversity Committee
- FDA-Cleared Zeta TMS Robotic System Moves Toward Deployment as FDA, DARPA and Commercial Catalysts Converge: NRx Pharmaceuticals (N A S D A Q: NRXP)