Hereditary Pancreatitis

CARMEL, Ind., Oct. 03, 2023 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc., a clinical stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced that results from the Phase 1 Study of MBX 2109, the company’s long-acting parathyroid hormone (PTH) peptide prodrug in development for the treatment of hypoparathyroidism (HP), will be featured in a late-breaking oral presentation at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting being held in Vancouver, Canada October 13-16, 2023. Presentation details: Title: Preliminary Data From a First-in-Human, Randomized, Double-blind, Placebo-Controlled, Phase 1 Study of MBX 2109, a Once-Weekly Parathyroid Hormone Replacement Therapy, in Healthy AdultsPresenting Author:Mary Jane Geiger, M.D., Ph.D.Presentation Number:1134Session:Late-Breaking Oral Presentations: New Insights for Skeletal FragilityDate/Time:Monday, October 16, 2023, 11:45-12:00 pm PTLocation:Vancouver Convention Centre, Vancouver, BC, Canada About Hypoparathyroidism Hypoparathyroidism (HP) is a rare endocrine disorder caused by a deficiency of parathyroid hormone that results in decreased calcium and increased phosphorus levels in the blood. HP affects approximately 200,000 individuals worldwide, most of whom develop the condition following damage to or removal of the parathyroid glands during thyroid surgery. HP is associated with a wide range of symptoms such as paresthesias, muscle cramps, seizures, an impaired quality of life, and an increased risk of comorbidities including kidney stones and impaired renal function. The goal of treatment is to maintain blood calcium levels in the low-normal range while preventing symptoms of hypocalcemia. Current standard of care consists of high doses of calcium supplements and active vitamin D, which may contribute to the risk of renal disease and do not address the underlying pathophysiology caused by a lack of parathyroid hormone. About MBX 2109 MBX 2109 is an investigational long-acting parathyroid hormone peptide prodrug in development as a PTH replacement therapy for hypoparathyroidism. It was designed with the company’s novel, proprietary Precision Endocrine Peptide™ (PEP™) platform technology to provide sustained PTH activity with a convenient once-weekly dosing regimen. In July 2022, MBX 2109 received Orphan Drug designation from the U.S. Food and Drug Administration for the treatment of hypoparathyroidism. MBX aims to simplify and improve an individual’s disease management, while relieving both the symptoms of the disorder and long-term complications. About MBX Biosciences MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide™ (PEP™) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives. MBX is advancing a pipeline of PEPs for clinically validated targets designed to deliver superior pharmaceutical properties and overcome key limitations of native peptide therapeutics. MBX’s pipeline includes its lead product candidate MBX 2109, completing Phase 1 development for the treatment of hypoparathyroidism, and MBX 1416, entering Phase 1 development for the treatment of post-bariatric hypoglycemia. The company is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, Norwest Venture Partners, OrbiMed, RA Capital Management and Wellington Management. MBX is based in Carmel, Indiana. To learn more, please visit the company website at www.mbxbio.com and follow us on LinkedIn and Twitter. Media Contact: Ian StoneEvoke Canaleian.stone@evokegroup.com619-849-5388 Investor Contact: Irina KofflerLifeSci Advisorsikoffler@lifesciadvisors.com917-734-7387

MBX 2109 was observed to be generally well-tolerated MBX 2109 increased albumin adjusted serum calcium and suppressed endogenous PTH(1-84) CARMEL, Ind., Sept. 11, 2023 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc., a clinical stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced positive results from the multiple ascending dose (MAD) portion of the Phase 1 trial of MBX 2109, the company’s long-acting parathyroid hormone (PTH) peptide prodrug in development for the treatment of hypoparathyroidism (HP). “We are pleased with the positive and encouraging data seen throughout our Phase 1 program which we believe provides initial validation of the potential benefits of our PEP platform technology,” said Kent Hawryluk, president and chief executive officer of MBX Biosciences. “We look forward to advancing MBX 2109, our lead product candidate and potentially best-in-class PTH replacement therapy, into the next stage of development as we prepare for our end of Phase 1 meeting with the FDA later this year. I would like to thank the study participants, study investigators, and our partners who contributed to this study in pursuing a treatment option for hypoparathyroidism, a rare endocrine disorder with significant unmet medical need worldwide.” The randomized, double blind, placebo-controlled Phase 1 trial enrolled 76 adults and was designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of MBX 2109 in healthy adult volunteers who were administered MBX 2109 subcutaneously. The primary endpoint was safety and tolerability, and secondary endpoints included PK and PD parameters. Single and multiple ascending doses of MBX 2109 were observed to be generally well-tolerated. The PK parameters reflected the prodrug design and were supportive of once-weekly administration and PD effects were consistent with the expected PTH pharmacology, as compared to placebo. Increases in albumin adjusted serum calcium and concomitant suppression of PTH(1-84) were observed in study participants treated once weekly with subcutaneously administered MBX 2109 for four doses. Full results of the study will be reported at an upcoming medical conference. About Hypoparathyroidism Hypoparathyroidism (HP) is a rare endocrine disorder caused by a deficiency of parathyroid hormone that results in decreased calcium and increased phosphorus levels in the blood. HP affects approximately 200,000 individuals worldwide, most of whom develop the condition following damage to or removal of the parathyroid glands during thyroid surgery. HP is associated with a wide range of symptoms such as paresthesias, muscle cramps, seizures, an impaired quality of life, and an increased risk of comorbidities including kidney stones and impaired renal function. The goal of treatment is to maintain blood calcium levels in the low-normal range while preventing symptoms of hypocalcemia. Current standard of care consists of high doses of calcium supplements and active vitamin D, which may contribute to the risk of renal disease and do not address the underlying pathophysiology caused by a lack of parathyroid hormone. About MBX 2109 MBX 2109 is an investigational long-acting parathyroid hormone peptide prodrug in development as a PTH replacement therapy for hypoparathyroidism. It was designed with the company’s novel, proprietary Precision Endocrine Peptide™ (PEP™) platform technology to provide sustained PTH activity with a convenient once-weekly dosing regimen. In July 2022, MBX 2109 received Orphan Drug designation from the U.S. Food and Drug Administration for the treatment of hypoparathyroidism. MBX aims to simplify and improve an individual’s disease management, while relieving both the symptoms of the disorder and long-term complications. About MBX Biosciences MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide™ (PEP™) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives. MBX is advancing a pipeline of PEPs for clinically validated targets designed to deliver superior pharmaceutical properties and overcome key limitations of native peptide therapeutics. MBX’s pipeline includes its lead product candidate MBX 2109, completing Phase 1 development for the treatment of hypoparathyroidism, and MBX 1416, entering Phase 1 development for the treatment of post-bariatric hypoglycemia. The company is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, Norwest Venture Partners, OrbiMed, RA Capital Management and Wellington Management. MBX is based in Carmel, Indiana. To learn more, please visit the company website at and follow us on LinkedIn and Twitter. Media Contact: Ian Stone Evoke Canale ian.stone@evokegroup.com 619-849-5388 Investor Contact: Irina Koffler LifeSci Advisors ikoffler@lifesciadvisors.com 917-734-7387

Beijing, May 22, 2023 (GLOBE NEWSWIRE) -- The 2023 China Gut Conference, held from May 20-22, 2023, successfully wrapped up at the China National Convention Center in Beijing. Under the theme "Innovation, Collaboration, and Symbiosis," Novozymes OneHealth (also known as OneHealth) assembled alongside an international array of authoritative experts and leading biotech companies. They united to exchange ideas on industry trends and to chart a future course for the development of gut health, with their discussions grounded in technological innovation and clinical evidence. OneHealth also utilized this platform to launch its new products and its official website in China. Collaborative and Symbiotic Efforts Driving Mutual Success OneHealth intends to build upon its longstanding partnership with Jiangnan University, facilitating enhanced communication in scientific research and talent exchange, and fostering the global implementation of probiotic-related technologies, with the goal of delivering more scientifically validated biotech solutions to the health industry. In a media interview, Jordan F. Dow, Head of Global Commercial at OneHealth, acknowledged that Jiangnan University was the inaugural academic partner of OneHealth, and the collaboration continues to this day. “The partnership has resulted in significant successes, such as SmartGuard (Lactobacillus plantarum CCFM8610), a product capable of removing harmful heavy metals from the body." Dow emphasized that “OneHealth remains committed to further collaboration, striving to develop scientifically validated health solutions informed by industry trends, scientific innovation, and extensive research.” The next stage of collaborative efforts involves enhancing the promotion and application of OneHealth’s product worldwide via global clinical trials and strategic marketing. It aspires to cooperate with multiple partners in conducting these global clinical trials, aiming to foster broader international recognition and utilization of Chinese probiotic strains. Launch of New Products: Leading the Segmented Market, Offering Fresh Choices for Gut Health OneHealth, a leader in providing solutions for gastric health, consistently innovates in this specialized field. Their latest effort, the Pylopass 2023 white paper, incorporates expert insights on HP eradication and prevention from "The 6th National Consensus Report on the Management of Helicobacter pylori Infection." The paper also gives a detailed explanation of the bioequivalence of Pylopass™ PRO, a product made using freeze-drying technology. Interestingly, this paper shows that it's as effective as the traditional inactivated Pylopass solution. This product can be incorporated into localized probiotic applications, expanding its usage possibilities. In response to consumers' evolving demand for more tailored probiotic solutions beyond general intestinal health, OneHealth has introduced a solution for irritable bowel syndrome: IBmeTM, featuring the Bifidobacterium longum 35624® strain. This strain, after being extensively tested in over ten clinical trials in the U.S., U.K., and France with nearly 1,000 participants, has shown positive effects on alleviating irritable bowel syndrome. The strain is now available in China with a proven application formula, setting the stage for swift commercialization. Additionally, OneHealth's global commercial launch of SmartGuard™, a Lactobacillus plantarum CCFM8610 strain developed in partnership with Jiangnan University, is generating interest. It is noted for its ability to decrease the body's absorption of harmful heavy metals and provides the dual health benefits of also providing relief from dermatitis. Round Table Forum: Focusing on Market Trends and JointDevelopment At the OneHealth Satellite Conference, the company hosted a roundtable forum featuring eminent industry professionals, including Professor Zhao Jianxin, Director of the School of Food Science and Technology at Jiangnan University, Professor Yang Ruifu, Chairman of the Committee of Probiotics Prebiotics and Health, Zhang Yusheng, Founder and CEO of Xingshulin Information Technology (Beijing) Co., Ltd, and Xue Yang, CEO of VitalNova Health Group Holdings Limited. The discussions spanned a range of topics, including the evolving trends in probiotics, the intersection of functional and health food, and the significant role Chinese strain research plays in global development. Spotlight on Academic Research: Stimulating Themed Discussions To ensure sustained vitality and competitiveness, OneHealth prioritizes scientific research and development, viewing technological innovation as a key driver of the company's growth. With a watchful eye on the cutting edge of global science and technology, OneHealth consistently strengthens its research and development, focusing on new technologies, techniques, and materials to foster the company's pursuit of excellence. Cheng Xion, General Manager of OneHealth Greater China, delivered a presentation at the conference, providing an analysis of the current probiotic industry landscape. He also shared his insights and future trends in the industry. OneHealth scholars Katy Sorensen and Fiona Kinnear offered in-depth discussions on academic research areas, specifically intestinal health and flora, as well as the brain-gut axis. They presented significant findings on the Bifidobacterium longum 1714® and 35624® combination strains, revealing their notable improvement in the symptoms of intestinal discomfort and associated psychosocial issues related to irritable bowel syndrome. This sharing of cutting-edge academic results promoted discussion on innovative solutions and underscored the importance of applying scientific discoveries to industrial applications. Website Launch: Enhancing Service to the Chinese Market According to data from Statista, the global probiotics market is projected to reach $91.1 billion by 2026. As the industry approaches the $100 billion mark, OneHealth remains dedicated to advancing health innovations, delving deeper into the implications of scientific discoveries, and shaping new paths in the industry to enhance human health. On May 20, OneHealth's Chinese website officially went live, improving communication with our Chinese customers and marking a new phase in cooperation and growth. This platform will provide detailed information about the company, products, and solutions, and will also serve as a convenient place to share its latest scientific insights and developments. Even though the OneHealth Satellite Conference has concluded, OneHealth’s journey continues. As it looks to the future, OneHealth remains committed to enhancing professional discourse, fostering collaboration and co-creation among industry experts, academics, and researchers, with a collective aim to pioneer new avenues in the realm of health. Tim Brown tim198515@gmail.com