Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multimedia
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multimedia
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

DEBIOPHARM APPLIES EXTENDED-RELEASE FORMULATION EXPERTISE TO REDUCE TREATMENT FREQUENCY BURDEN FOR ACROMEGALY & GEP-NET PATIENTS


News provided by

Debiopharm International SA

12 Jan, 2023, 09:00 GMT

Share this article

Share toX

Share this article

Share toX

-  Acromegaly and gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are rare diseases that require life-long chronic treatment. Monthly somatostatin analog (SSA) injections are the standard of care as first-line medical treatment.

-  Debiopharm is developing Debio 4126, a novel 3-month extended-release octreotide formulation, to optimize acromegaly and GEP-NET patient care by reducing injection frequency, which translates into an improved quality of life and less time spent with medical visits.

-  Debio 4126 is currently being investigated in two clinical studies. One of them (study Debio 4126-102) is a phase 1b study in patients with acromegaly or GEP-NETs. This study was designed to characterize the pharmacokinetic, pharmacodynamic, efficacy, safety, and tolerability profiles of Debio 4126 administered intramuscularly (IM) every 3 months over an extended period.

LAUSANNE, Switzerland, Jan. 12, 2023 /PRNewswire/ -- Debiopharm (www.debiopharm.com), a Swiss-based, global biopharmaceutical company, today announced that the first patient was dosed with Debio 4126, a 3-month extended-release formulation of octreotide, in their open-label, non-randomized, single-arm, multicenter phase 1b study (Debio 4126-102). The study is composed of two patient cohorts – 1 group of patients with acromegaly and 1 group with functioning GEP-NETs Patients will receive 4 injections of Debio 4126 for a total treatment duration of 48 weeks.

Debio 4126 is currently the only 3-month SSA in clinical development. The development of Debio 4126 arises from Debiopharm's wish to leverage their modified-release Debiosphere™ technology to alleviate the treatment burden of patients with rare diseases, such as acromegaly and GEP-NETs, by reducing the injection frequency to 4 injections per year.

In healthy volunteers, Debio 4126, an extended-release formulation of octreotide, exhibited good bioavailability and sustained release for up to 3 months.1 It has the potential to offer efficacy and safety similar to those of marketed 1-month SSAs. If successful, Debio 4126 will equip healthcare professionals with a new, more convenient option for treating acromegalic and GEP/NET patients.

"Going into this 2-year long phase 1b trial, we look forward to ascertaining the benefits of this extended-release formulation. We believe that patient quality of life can be improved through the substantially reduced number of injections, from 12 to 4/year," explained Dr Simona Ispas Jouron, Senior Medical Director, Endocrinology & Rare Diseases at Debiopharm.

Prior to this compound, Debiopharm's extended-release formulation expertise extends over more than 35 years with the development of multiple formulations of agonist analogue triptorelin, benefiting patients affected by prostate cancer, breast cancer, endometriosis, central precocious puberty (CPP), and uterine myomas.

"The success of triptorelin is linked to our modified-release Debiosphere™ technology that has contributed to the improvement of the quality of life of patients treated long-term, particularly with our 1, 3 and 6-month formulations of triptorelin and now with Debio 4126. This formulation adds significant value to an efficacious and safe standard of care." expressed Bertrand Ducrey, CEO of Debiopharm.

About Acromegaly

Acromegaly is a rare chronic disorder caused by excessive GH secretion by pituitary adenomas, with more than 95% of cases being benign.2 The condition most commonly affects middle-aged adults, with a slight predominance of female patients (52-60%)3 and equal distribution among ethnicities. The disease is clinically diagnosed based on characteristic symptoms, including progressive skeletal and soft tissue overgrowth, mainly at the extremities (hands and feet) and head. Diagnosis is confirmed biochemically via increased serum concentrations of GH and IGF-1. Acromegaly is associated with a twofold increase in mortality relative to that expected in the general population, mostly due to cardiovascular events. Associated risk factors include hypertension, glucose metabolism abnormalities, dyslipidemia, abdominal adiposity, and peripheral insulin resistance (metabolic syndrome). Untreated acromegaly is associated with a reduced quality of life and life expectancy shortened by approximately 10 years.2


About Gastro-entero-pancreatic neuroendocrine tumors (GEP-NET)

GEP-NETs are rare and complex malignant solid tumors, derived from neuroendocrine cells, occurring in various sites along the gastrointestinal tract. Although these tumors have been considered rare, the most recent data from the US Surveillance Epidemiology and End Results show an increase of more than 400% in the incidence of these diseases over the period from 1973 to 2004. 4 Age at diagnosis is generally younger than 50 years, and these tumors may arise sporadically or because of hereditary predisposition. Survival of patients with GEP-NETs depends on the stage and histology. Patients with well and moderately differentiated metastases have a 5-year survival probability of 35%, while poorly differentiated metastases lead to a 5-year survival probability of 4%4

About Debio 4126

Octreotide is a synthetic octapeptide that mimics the pharmacology of endogenous somatostatin (SST). Currently, octreotide is available as immediate-release (Sandostatin®) and 4-week long-release formulations (Sandostatin LAR®). Debio 4126 is a novel, 3-month extended-release formulation of octreotide being developed by Debiopharm.

Debiopharm's commitment to patients 

Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology and bacterial infections. We identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then select pharmaceutical commercialization partners to maximize patient access globally. 

For more information, please visit www.debiopharm.com 
We are on Twitter. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews 

Debiopharm Contact 
Dawn Bonine
Head of Communications
dawn.bonine@debiopharm.com 
Tel: +41 (0)21 321 01 11

References

[1] Bellon A, et al. ENEA. 2022.

[2] Chanson P, et al. Pituitary tumours: acromegaly. Best Pract Res Clin Endocrinol Metab. 2009;23(5):555-74.

[3] Fleseriu M, et al. Acromegaly: pathogenesis, diagnosis, and management. Lancet Diabetes Endocrinol 2022 Nov;10(11):804-826

[4] Yao, et al. Journal of clinical oncology : official journal of the American Society of Clinical Oncology vol. 26,18 (2008): 3063-72.

Modal title

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.