Trending...
- Obey God Clothing Launches Urban Christian Apparel Line Serving All Ages
- Zivra AI Launches Real-Time Business Health and Financial Intelligence for SMEs
- The New Monaco of the South (of Italy)
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
- CollabWait to Launch Innovative Waitlist Management Platform for Behavioral Health Services
- Urban Bush Women Celebrates Bessie Award Nominations & Winter 2026 Touring
- Imagen Golf Launches "Precision Lessons" with Trackman iO in Newtown, PA
- New Report Reveals Surprising Trends in Illinois Airport Accidents
- PebblePad Acquires myday to Deliver Unified Digital Campus Experiences for Student Success
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
- Adam Clermont Releases New Book – Profit Before People: When Corporations Knew It Was Dangerous and Sold It Anyway
- Dirty Heads, 311, Tropidelic, and The Movement to Headline Everwild Music Festival in 2026 with its largest lineup to date!
- VIP Vacations Honored by Lomas as One of Top Overall Travel Agencies
- The Stork Foundation Announces 2025 Year-End Impact and Grant Awards Amid Rising National Demand
- Stout Industrial Technology Appoints Paul Bonnett as Chief Executive Officer
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
Filed Under: Business
0 Comments
Latest on The PennZone
- RNHA Affirms Support for President Trump as Nation Marks Historic Victory for Freedom
- American Laser Study Club Announces 2026 Kumar Patel Prize in Laser Surgery Recipients: Ann Bynum, DDS, and Boaz Man, DVM
- Lineus Medical Completes UK Registration for SafeBreak® Vascular
- Canyons & Chefs Announces Revamped Homepage
- $140 to $145 Million in 2026 Projected and Profiled in New BD Deep Research Report on its Position in $57 Billion US Marine Industry; N Y S E: OTH
- Really Cool Music Releases Its Fourth Single - "So Many Lost Years"
- MGN Logistics Acquires Fast Service LLC, Fueling MyMGN Marketplace Expansion and Supercharging Expedited Coverage Nationwide
- The Wait is Over: Salida Wine Festival Announces Triumphant 2026 Return After Seven-Year Hiatus
- Graduates With $40K in Student Debt Are Buying Businesses Instead of Taking Entry-Level Jobs
- Anne Seidman: Within the Lines
- How Democrats Made Healthcare More Expensive in 2026
- Inkdnylon Launches Bilingual Ask Inkdnylon Platform
- JS Gallery Brings Global Voices to LA Art Show 2026 with "OFF SCRIPT" Exhibition
- ANTOANETTA Partners With Zestacor Digital Marketing to Expand Online Presence for Handcrafted Luxury Jewelry
- Mitchell Sipus Releases New Dance Single "Can U"
- FrostSkin Launches Kickstarter Campaign for Patent-Pending Instant-Chill Water Purification Bottle
- The New Monaco of the South (of Italy)
- OctoNerv Completes Functional Prototype of Electronic Breast Nipple Implant (EBNI)
- Zivra AI Launches Real-Time Business Health and Financial Intelligence for SMEs