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Study to evaluate the safety and tolerability of KIT2014, an inhaled peptide therapy designed to enhance Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) function, act as a bronchodilator, and reduce inflammation KIT2014 is being developed as a CFTR enhancer, acting as an add-on treatment to existing CFTR modulators, targeting improved lung function and reduced inflammation in Cystic Fibrosis patients TURIN, Italy, Oct. 30, 2024 /PRNewswire/ -- Kither Biotech, a clinical-stage biotech company focused on innovative therapies for respiratory diseases, today announced the start of a Phase 1 clinical study of KIT2014, a novel inhaled peptide therapy for Cystic Fibrosis (CF). KIT2014 is designed as an add-on therapy to existing CFTR modulators and works by enhancing CFTR gating, promoting bronchodilation, and reducing inflammation through PDE3/4 inhibition. "The initiation of this Phase 1 study marks a significant step forward for Kither Biotech and the CF community," said Dr. Dimitrios Goundis, CEO of Kither Biotech. "KIT2014 addresses mucus obstruction, chronic inflammation, and bronchoconstriction-three critical challenges that affect CF patients even with current CFTR modulators. We are excited to begin assessing the potential of KIT2014 to improve treatment outcomes." About the KIT2014 Study This Phase 1 double-blind, placebo-controlled study will primarily evaluate the safety and tolerability of single and multiple doses of KIT2014 in healthy adult volunteers, followed by an assessment of pharmacokinetics. For more information, visit clinicaltrials.gov (NCT06659757). About Cystic Fibrosis Cystic fibrosis is a life-limiting genetic disease that affects approximately 130,000 people worldwide. It is caused by mutations in the CFTR gene, which lead to defective chloride ion transport across cell membranes, resulting in the buildup of thick, sticky mucus in the lungs. This mucus impairs mucociliary clearance, promotes chronic bacterial infections, and triggers persistent inflammation, leading to progressive lung damage. Unmet Medical Need for KIT2014 Despite significant advances from CFTR modulators, many CF patients continue to experience persistent inflammation and recurring infections, severely impacting lung function and overall health. Neutrophil-driven inflammation, marked by elevated levels of neutrophil elastase, remains a major contributor to lung damage in CF patients. KIT2014 addresses these issues with an innovative solution that directly targets this inflammation, reduces neutrophil activation, and provides an additional therapeutic benefit that complements existing CF treatments. KIT2014 has the potential to improve significantly long-term outcomes for CF patients. Mechanism of Action of KIT2014 KIT2014 is a peptide-based therapy designed to target these fundamental issues by acting on multiple pathways in CF lung disease. Delivered through inhalation, it allows direct targeting of the lungs. By inhibiting phosphodiesterase 3/4 (PDE3/4), it elevates cyclic adenosine monophosphate (cAMP) levels. In bronchial epithelial cells, this mechanism enhances CFTR gating and improves chloride ion transport, while in airway smooth muscle cells, it acts as a bronchodilator. Additionally, KIT2014 reduces neutrophil-driven inflammation through PDE3/4 inhibition. Together, these mechanisms position KIT2014 as a promising add-on to existing CFTR modulator therapies. About Kither Biotech Kither Biotech is a clinical-stage biotech company focused on developing innovative therapies for respiratory diseases. Kither Biotech's lead program, KIT2014, is an innovative inhaled peptide therapy aimed at enhancing CFTR function, providing bronchodilation, and reducing inflammation in CF patients. By targeting multiple pathways in CF lung disease, Kither Biotech is committed to addressing unmet medical needs and improving the quality of life for patients suffering from severe respiratory conditions. The company has successfully raised $26 million to date from investors including Claris Ventures, 2Invest, 3B Future Health, CDP Venture Capital, Italian Angels for Growth, Club degli Investitori, Ersel and ACE Venture. For more information, please visit and follow us on LinkedIn. SOURCE Kither Biotech WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NANJING, China, Oct. 30, 2024 /PRNewswire/ -- Oct 24th 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that a new clinical study with major clinical findings regarding Sanbexin (edaravone and dexborneol concentrated solution for injection) has been published at the 16th World Stroke Conference (WSC). According to the latest data, the administration of edaravone dexborneol (Sanbexin®) in patients with acute ischemic stroke (AIS) before receiving endovascular thrombectomy significantly improved neuro-function recovery and reduced disability from stroke. Continue Reading Professor Yongjun Wang presented a late-breaking oral presentation at WCS Presented as a WCS late-breaking oral presentation by Professor Yongjun Wang from Beijing Tiantan Hospital, the study entitled "Treatment of Acute ischemic Stroke with Edaravone dexborneal 2" ("TASTE-2") has caught wide spread attention among neurology academic circle in the world. Stroke is the leading cause of death and disability in adults in China, while AIS accounts for about 70% of all strokes. About 40% of AIS patients fall into the category of large vessel occlusion (LVO), a subtype of AIS with higher disability and mortality. After stroke, reperfusion treatments (e.g., thrombolysis and thrombectomy) are used to restores blood supply to the brain as soon as possible. The endovascular thrombectomy (EVT), an important advance in reperfusion therapy in recent years, can achieve recanalization in about 70% to 90% of patients with the LVO stroke, but only half of these patients achieve favorable brain function recovery A significant proportion of the patients who received EVT remain disabled to varying degrees after 90 days of treatment. TASTE-2 study is a multicenter, double-blind, randomized, placebo-controlled clinical study. From March 2022 to May 2023, a total of 1362 AIS patients with a large-vessel occlusion (LVO) in the anterior circulation were enrolled. Patients were randomly allocated (1:1) to receive edaravone dexborneol (edaravone, 30 mg; (+)-dexborneol, 7.5 mg) or placebo prior to EVT and continued twice a day over a consecutive period of 10-14 days. As a primary efficacy outcome, 379 (55.0%) patients in the edaravone dexborneol group and 333 (49.6%) in the placebo group achieved a mRS 0-2 at day-90 (odds ratio [OR] 1.24, 95% CI 1.00-1.54; risk ratio [RR] 1.11, 95% CI 1.00-1.23). All safety outcomes were similar between both groups. This suggests that Edaravone dexborneol could improve the favorable functional outcome at 90 days in AIS patients within 24-hour of symptom onset who underwent EVT. Sanbexin® (Edaravone dexborneol Concentrated Solution for Injection) is a multi-targeted brain cell protection agent developed by Simcere Pharmaceutical Co., Ltd, and is the only approved innovative drug in the field of stroke treatment worldwide since 2015. Composed of edaravone and dexborneol, two active ingredients with synergistic anti-oxidant and anti-inflammatory effects, the drug can significantly reduce brain cell injury or impairment caused by AIS. According to the recommendations of the Stroke Academic Roundtable Meeting (STAIR), brain cytoprotectants can reduce ischemic brain injury, especially when combined with thrombectomy. The scientific community has also been working on brain cytoprotective agents for stroke treatment for decades. However, due to the complexity of stroke pathophysiology, single-target drugs have been found to have limited efficacy and difficult to be developed clinically. On the other hand, the clinical study of multi-target brain cytoprotectants continue to progress. Previously, the TASTE study led by Professor Yongjun Wang's team in Beijing Tiantan Hospital and the TASTE-SL study led by Professor Dongsheng Fan in Peking University Third Hospital confirmed the efficacy of edaravone dexborneol injection and sublingual tablets in AIS patients who do not receive reperfusion treatment. The latest results of the TASTE-2 study provide key clinical medical evidence for Sanbexn® as a multi-target brain cell protection strategy combined with reperfusion in the treatment of acute ischemic stroke. Sanbexin® is expected to be used as a concomitant drug for endovascular treatment such as thrombectomy, particularly before reperfusion, to further improve the effect of stroke treatment and reduce stroke disability. SOURCE Simcere Pharmaceutical Group Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MINNEAPOLIS, Oct. 29, 2024 /PRNewswire/ -- GT Metabolic Solutions Inc., the global leader in magnetic compression anastomosis surgery, announced today that the U.S. Food and Drug Administration (FDA) cleared GT Metabolic's MagDI™ System for side-to-side duodeno-ileal (DI) anastomosis.1 The MagDI™ System is the first-of-its-kind minimally invasive surgical technique to create anastomosis without foreign materials left behind.2-4 Continue Reading Self-aligning GT Metabolic MagDI™ System magnets fused together Pictured: U.S. bariatric surgeon Paul Enochs, MD, alongside GT Metabolic MagDI™ System inventor Michel Gagner, MD, perform a side-to-side duodeno-ileal (DI) anastomosis "With this FDA clearance, the MagDI™ System is poised to launch a new frontier in healthcare as we continue to deliver on our visionary milestones for efficacy in magnetic surgery," said MedTech entrepreneur Thierry Thaure, CEO and co-founder of GT Metabolic. "After completing over 100 cases in seven clinical trials across eight countries, launching in the U.S. market with this groundbreaking technology is a major progression in our journey to advance minimally invasive surgery in the bariatric space as well as in future areas." The MagDI™ System is composed of the GT Metabolic linear DI magnets, the GT Metabolic delivery system, and the GT Metabolic laparoscopic positioning device (LPD). During the MagDI procedure two linear magnets are delivered orogastrically to the patient. The magnets are positioned laparoscopically and self-align through the small bowel. After several weeks the magnets compress the tissue fusing together forming an anastomosis. The magnets detach and are expressed naturally. The anastomosis created with magnet compressions happens without the cutting or piercing of intestinal tissue that occurs with the current practice of stapling or suturing. The MagDI™ System is designed for more consistent tissue alignment, central necrosis, and circumferential healing while leaving no foreign materials behind to impede the natural tissue healing process.2-4 The MagDI™ System was cleared after clinical data submitted to the FDA showed the system performed as intended. In all subjects, the MagDI™ System created patent side-to-side duodeno-ileal anastomosis. There were no reports of anastomotic bleeding, leakage, or obstruction.1 "It's a paradigm shift creating a new standard of care that democratizes anastomosis creation," said inventor Michel Gagner, MD, FRCSC, FACS, and chief medical officer and co-founder of GT Metabolic. "We're providing the surgical community with a novel approach to minimally invasive surgery shown to have zero bleeds and zero leaks. Suturing and stapling bowel tissue for anastomosis creation will become outdated. Magnetic compression anastomosis technology will revolutionize the industry." Prominent U.S. bariatric surgeon Paul Enochs, MD, FACS, FASMBS, of Bariatric Specialists of the Carolinas was the first U.S. surgeon to have patients enrolled in clinical trials using the MagDI™ System. "Seeing the science and technology that's behind this procedure has definitely opened my eyes to what the future could hold," said Enochs. GT Metabolic is currently identifying key sites for additional clinical studies. Key opinion leaders in the bariatric surgery specialty interested in participating in the MagDI™ System launch can contact the company at GT Metabolic. About GT Metabolic ™ Solutions Inc. GT Metabolic Solutions Inc. is leading the world with its development of magnetic compression anastomosis technologies for next-stage minimally invasive procedures. An elegant approach that uses magnets to help achieve anastomosis, the incisionless, sutureless, staple-free technique leaves no foreign material to impede the natural tissue healing process. Working in tandem with renowned global experts, our team has engineered a magnetic compression solution called delayed anastomosis technology (DAT) that surgeons can use to create consistent anastomosis while helping minimize potential complications, such as leaks and bleeds, in challenging applications. Our solution democratizes the surgical approach to anastomosis. It can be used in procedure staging and is 100% reversible. Committed to improving patients' lives and healthcare provider outcomes, GT Metabolic Solutions Inc. is disrupting the market by introducing magnetic compression anastomosis technologies to bariatric, metabolic and digestive health providers in the U.S. and abroad. 510(k) No. K242086. Clearance for Magnetic Compression Anastomosis System (MagDI System) issued by the U.S. Food and Drug Administration. 24 October 2024. Gagner, M., Almutlaq, L., Cadiere, G.-B., Torres, A. J., Sanchez-Pernaute, A., Buchwald, J. N., & Abuladze, D. (2023). Side-to-side magnetic duodeno-ileostomy in adults with severe obesity with or without type 2 diabetes: Early outcomes with prior or concurrent sleeve gastrectomy. Surgery for Obesity and Related Diseases. Gagner, M., Abuladze, D., Koiava, L. et al. First-in-Human Side-to-Side Magnetic Compression Duodeno-ileostomy with the Magnet Anastomosis System. OBES SURG 33, 2282–2292 (2023). Gagner M, Cadiere GB, Sanchez-Pernaute A, Abuladze D, Krinke T, Buchwald JN, Van Sante N, Van Gossum M, Dziakova J, Koiava L, Odovic M, Poras M, Almutlaq L, Torres AJ. Side-to-side magnet anastomosis system duodeno-ileostomy with sleeve gastrectomy: early multi-center results. Surg Endosc. 2023 Aug;37(8):6452-6463. doi: 10.1007/s00464-023-10134-6. Epub 2023 May 22. PMID: 37217682; PMCID: PMC10202352. Legal Disclaimer / Forward-Looking Statements This release is for informational purposes only and is not an offer to sell securities or a solicitation of an offer to buy any securities and may not be related upon in connection with the purchase or sale of any security. This release may contain forward-looking statements regarding projected business performance, operating results, financial condition and other aspects of the company. These statements also include estimates of the technology developments, adoption of the company's products and improvement of patient outcomes. Please be advised that such statements are estimates only and there is no assurance that the results stated or implied by forward-looking statements will actually be realized by the company. Forward-looking statements may be based on management assumptions that prove to be wrong. The company's predictions may not be realized for a variety of reasons, including due to competition, hospital sales cycles, and engineering or technical issues, among others. The company and its business are subject to substantial risks and potential events beyond its control that would cause material differences between predicted results and actual results, including the company incurring operating losses and experiencing unexpected material adverse events. Learn more about magnetic compression anastomosis and GT Metabolic™ Solutions, Inc. Contact for US Medical Community and Technology: Ronald Galovich, VP Sales & Marketing GT Metabolic Solutions, Inc. [email protected] Contact for Investment and International: Thierry Thaure, Chief Executive Officer, Co-Founder GT Metabolic Solutions, Inc. [email protected] SOURCE GT Metabolic Solutions WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED