Latest news with #Dupuytren
Korea Herald
07-05-2025
- Business
- Korea Herald
Connext Successfully Completes Dose Escalation Part of CNT201 Phase 1/2 Clinical Trial for Dupuytren's Contracture
– Conducted under U.S. FDA-cleared IND – Plans for Phase 2 initiation in Q3 2025 and expansion into Peyronie's disease SEOUL, South Korea, May 7, 2025 /PRNewswire/ -- Connext, a clinical stage biotechnology company, announced the successful completion of the dose escalation (Phase 1) part of its Phase 1/2 clinical trial for CNT201, its recombinant collagenase therapeutic for Dupuytren's contracture. The trial was conducted in an open-label format and confirmed both the safety and efficacy of CNT201: no dose-limiting toxicities were observed, and clear therapeutic benefits were demonstrated. Key Clinical Results and Future Plans Differentiation Through Innovative Recombinant Collagenase Currently, Endo's Xiaflex is the only commercially available collagenase injection for Dupuytren's contracture. CNT201 is being developed as an alternative to Xiaflex and is expected to significantly improve patient access to non-surgical treatment. Collagenase is originally produced by fermentation of the pathogenic microorganism Clostridium histolyticum, which carries inherent risks of contamination with various toxins. In contrast, CNT201 is the world's first recombinant collagenase therapeutic developed using genetic engineering technology, eliminating the risk of contamination from toxins or animal-derived substances. This ensures superior quality, consistent efficacy, and differentiated safety profiles. Connext is also pursuing a Phase 2 IND for Peyronie's disease, based on the same mechanism of action, and aims to obtain U.S. FDA IND clearance in 2025. Additional development for aesthetic indications such as cellulite is also underway. Statement from Woo J ong Lee, CEO of Connext "By confirming both safety and efficacy in the dose escalation part of Phase 1/2 study, CNT201 offers a new non-surgical treatment option for patients with Dupuytren's contracture. We aim to complete global new drug development with Phase 3 entry in 2027 and demonstrate the unique advantages of our innovative recombinant therapeutic," said Woo Jong Lee, CEO of Connext.
Associated Press
17-02-2025
- Health
- Associated Press
Endo Launches 'Steve's Journey,' the First Branded Dupuytren's Contracture Commercial for XIAFLEX® (collagenase clostridium histolyticum)
Campaign builds on the momentum of Endo's disease awareness efforts. Commercial features a real patient—who was an untreated patient in a prior Endo video series—and his wife, sharing their personal experience with the condition and the patient's treatment with XIAFLEX®. Dupuytren's contracture is a progressive hand condition affecting an estimated 17 million Americans, making it likely that most people know someone who has been impacted. MALVERN, Pa., Feb. 17, 2025 /CNW/ -- Endo, Inc. (OTCQX: NDOI) announced today the launch of its new branded television commercial, Steve's Journey. The campaign, featuring a real Dupuytren's contracture patient, encourages patients to consult a hand specialist and ask about XIAFLEX® (collagenase clostridium histolyticum), the only FDA-approved nonsurgical treatment for Dupuytren's contracture. Dupuytren's contracture is a progressive hand condition in which a collagen rope-like cord forms beneath the skin of the palm, pulling fingers inward toward the palm.1,2 It affects an estimated 17 million Americans.3,4* 'Those with the best understanding of Dupuytren's contracture are patients who have faced similar challenges and uncertainties,' said Justin Mattice, Vice President & General Manager, Branded Specialty at Endo. 'By spotlighting authentic experiences like Steve's, we are emboldening patients to connect with a hand specialist and ask for nonsurgical XIAFLEX®, positioning them as knowledgeable decision makers.' Do not receive XIAFLEX® if you have had an allergic reaction to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX®, or to any other collagenase product. Please note that, receiving an injection of XIAFLEX® may cause damage to a tendon or ligament in your hand and cause it to break or weaken. Steve's Sequel This isn't Steve's first time in the spotlight. Endo's Coffee & Cords video series featured five patients at different points in their treatment journeys, and Steve lent his perspective as an untreated Dupuytren's contracture sufferer. After Coffee & Cords wrapped, Steve chose to get treated with XIAFLEX®. Steve's Journey revisits Steve's experience with the condition, and it highlights his treatment and recovery. The campaign also incorporates the partner perspective by including Steve's wife, Gisele. 'Endo is passionate about using firsthand experiences to amplify the voices of real-life patients,' noted Dayna Sracic, Executive Director, Consumer Marketing at Endo. 'By sharing these powerful, personal stories, we believe we can inspire and educate others regarding Dupuytren's contracture and nonsurgical treatment with XIAFLEX®.' Insights-Driven Campaign Endo's own research and consumer insights show many Dupuytren's contracture patients delay treatment due to concerns about surgery, often adapting to the condition instead.5† The branded approach puts patients in the driver's seat, giving them the knowledge and product name for a nonsurgical option. Endo's research indicates that Dupuytren's contracture patients that ask for XIAFLEX® by name receive the medication more than half of the time. Patient-Centric Campaign Creative The commercial opens with a close-up of Steve's hand, as he and Gisele describe how Dupuytren's contracture made everyday tasks difficult. The scene transitions to them holding hands, with Steve—now treated with XIAFLEX®—expressing how much he missed this simple intimacy with his wife. Additional shots show Steve's hands-on approach to life: working on a laptop, placing his hand flat on a table, flexing it while driving, and enjoying outdoor activities with Gisele. These moments demonstrate how XIAFLEX® has helped Steve regain the freedom to live life on his own terms. Through Steve's Journey, Endo aims to help more Americans living with Dupuytren's contracture by showcasing the outcomes of patients who have completed their nonsurgical treatment journey with XIAFLEX®. Underscoring the desire of many patients to lead a hands-on life, the campaign drives to Watch the commercial. Media Buy The 60-second spot will air during a variety of programming, including news, sports (e.g., NASCAR and NCAA basketball), and popular TV series across networks (e.g., Survivor and Matlock), as well as on cable channels (e.g., History and Discovery), on streaming services like Hulu and Amazon, and online. About Dupuytren's Contracture Dupuytren's contracture is a lifelong condition that may get worse over time. It's caused by a buildup of collagen in the hand, which forms a rope-like cord that pulls fingers toward the palm so they can't be straightened. As Dupuytren's contracture progresses, it may become difficult for individuals to use their hand(s) for daily tasks and activities.1,2 WHAT IS XIAFLEX®? XIAFLEX is a prescription medicine used to treat adults with Dupuytren's contracture when a 'cord' can be felt. It is not known if XIAFLEX is safe and effective in children under the age of 18. IMPORTANT SAFETY INFORMATION FOR XIAFLEX Do not receive XIAFLEX if you have had an allergic reaction to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX. XIAFLEX can cause serious side effects, including: Tendon rupture or ligament damage. Receiving an injection of XIAFLEX may cause damage to a tendon or ligament in your hand and cause it to break or weaken. This could require surgery to fix the damaged tendon or ligament. Call your healthcare provider right away if you have trouble bending your injected finger (towards the wrist) after the swelling goes down or you have problems using your treated hand after your follow-up visit Nerve injury or other serious injury of the hand. After finger procedures, some people developed tears in the skin (lacerations), and local skin and soft-tissue necrosis (death of skin cells). Some lacerations and necrosis required skin grafting, or other surgery including amputation. Call your healthcare provider right away if you get numbness, tingling, increased pain, or tears in the skin (laceration) in your treated finger or hand after your injection or after your follow-up visit Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive XIAFLEX because it contains foreign proteins. Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX: hives swollen face breathing trouble chest pain low blood pressure dizziness or fainting Fainting. Fainting (passing out) or near fainting can happen in people who receive XIAFLEX, especially following finger procedures If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away. Increased chance of bleeding. Bleeding or bruising at the injection site can happen in people who receive XIAFLEX. Talk to your healthcare provider if you have a problem with your blood clotting. XIAFLEX may not be right for you. Before receiving XIAFLEX, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX injection, or have a bleeding problem or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using XIAFLEX with certain other medicines can cause serious side effects. Especially tell your healthcare provider if you take medicines to thin your blood (anticoagulants). If you are told to stop taking a blood thinner before your XIAFLEX injection, your healthcare provider should tell you when to restart the blood thinner. Ask your healthcare provider or pharmacist for a list of these medicines if you are unsure. The most common side effects with XIAFLEX for the treatment of Dupuytren's contracture include: swelling of the injection site or the hand bruising or bleeding at the injection site pain or tenderness of the injection site or the hand swelling of the lymph nodes (glands) in the elbow or armpit itching breaks in the skin redness or warmth of the skin pain in the armpit Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with XIAFLEX. For more information, ask your healthcare provider or pharmacist. Rx Only Click for full Prescribing Information, including Medication Guide. About Endo Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the statements by Mr. Mattice and Ms. Sracic and any statements relating to product efficacy, potential treatments or indications, therapeutic outcomes or treatment responses, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as 'believes,' 'expects,' 'anticipates,' 'intends,' 'estimates,' 'plan,' 'will,' 'may,' 'look forward,' 'intends,' 'guidance,' 'future,' 'potential' or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: changes in competitive, market or regulatory conditions; changes in legislation or regulations; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition; the timing and uncertainty of the results of the research and development and the regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; litigation and other disputes; consumer and physician acceptance of current and new products; the performance of third parties upon whom we rely for goods and services; issues associated with our supply chain; the ability to develop and expand our product pipeline, to launch new products and to continue to develop the market for our products; and the effectiveness of advertising and other promotional campaigns. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading 'Risk Factors' in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. *Dupuytren's contracture prevalence estimation calculation: average Dupuytren's contracture prevalence in the US (5%) multiplied by US population (332 million per 2021 US Census data) = ~17 million. †Data sourced from 2024 consumer market research based on a web-based survey of 200 adults who were either diagnosed with Dupuytren's contracture or believe they have Dupuytren's contracture based on a detailed description of symptoms. References Hurst, LC, Badalamente, MA, et al. New England Journal of Medicine.2009;361(10),968-979. Bayat, A, McGrouther, DA. Annals of the Royal College of Surgeons of England. 2006;88(1),3-8. 'How common is Dupuytren disease?' Dupuytren Research Group. April 1, 2017. Accessed January 13, 2025. 'U.S. and world population clock.' U.S. Census Bureau. Updated April 13, 2023. Accessed January 13, 2025. 'Dupuytren's contracture consumer awareness trial usage online survey report.' Endo USA, Inc. 2024.
