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Immunic CMO discusses role of clinical trials in biotech development for Clinical Trials Day

Immunic Inc

Immunic Inc (NASDAQ:IMUX) chief medical officer Dr Andreas Muehler discusses the importance of clinical trials in the biotech industry to mark Clinical Trials Day on May 20. Dr Muehler noted that Immunic focuses on translating research ideas into clinical trials to demonstrate clinical proof of concept as well as safety and efficacy of a drug candidate. He explained the stages of clinical development, from preclinical trials to late-stage phase 3 trials and commercialization. Preclinical trials involve testing in animals and cell cultures to ensure safety before human testing begins. Phase 1 trials assess safety and pharmacokinetics, while phase 2 trials determine the appropriate dosage. Phase 3 trials involve large-scale testing to obtain statistically significant outcomes for regulatory approval. Dr Muehler emphasized the importance of continuous clinical development, even after drug approval, to monitor for rare side effects and test in different populations. Clinical trials at Immunic are organized by medical and clinical operations teams and executed with the help of contract research organisations (CROs) to manage the trials across various countries. Dr Muehler highlighted the challenges in clinical trials, such as patient recruitment and the need for effective planning and communication with key opinion leaders and investigators. He shared that staying in close contact with investigators through meetings, site visits, and newsletters helps in efficient trial execution and patient enrolment. Immunic's approach has been successful in rapidly enrolling patients for trials, particularly in multiple sclerosis studies, he added. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

May 20, 2024 10:00 AM Eastern Daylight Time

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Neural Therapeutics - How do we prevent people getting addicted to opioids?

Neural Therapeutics Inc.

Neural Therapeutics CEO Ian Campbell is answering some of the questions raised by Scientific Advisor Professor David Nutt's presentation on the potentially revolutionary untapped effects of psychedelic medicine. Today's questions asks: "The opioid crisis has touched every sector of society and shows no sign of stopping. How do we prevent more people from becoming addicted?" He emphasised that contrary to common concerns, the substances developed by the company have not shown addictive properties in clinical trials. Campbell highlighted that there is no evidence of withdrawal symptoms in patients. Moreover, ongoing scientific work supports the effectiveness of these substances in treating individuals with substance use disorders. The presentation focused on what Professor Nutt describes as the utility of psychedelic compounds and their potential to transform the treatment of mental illness. To watch the full presentation, click here: https://www.proactiveinvestors.co.uk/companies/news/1035785/professor-david-nutt-presents-his-insights-into-psychedelic-medicine-neural-therapeutics-1035785.html Neural Therapeutics is a drug-discovery company focusing on plant-based active substances with the goal of delivering beneficial, over-the-counter dietary supplements and psychedelic-based therapeutic medicines to treat serious mental ailments where no significant treatment is available today. Contact Details Proactive United States +1 347-449-0879 action@proactiveinvestors.com

May 20, 2024 09:00 AM Eastern Daylight Time

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Immunic chief medical officer discusses promising treatments to mark World IBD Day

Immunic Inc

Immunic Inc (NASDAQ:IMUX) chief medical officer Dr Andreas Muehler discusses Inflammatory Bowel Disease (IBD) with Proactive's Stephen Gunnion to mark World IBD Day on May 19. Muehler explained that IBD encompasses Crohn's disease and ulcerative colitis, characterised by an immune response triggered by the interaction between gut bacteria and the immune system, leading to bowel wall damage and ulcerations. This condition affects 1-2% of the population, presenting significant social challenges due to symptoms like diarrhoea and abdominal pain, which can limit social and professional activities. Currently, IBD is managed with immunosuppressive drugs, which, while effective, increase susceptibility to infections and other autoimmune diseases and often show immunosuppression. Dr Muehler highlighted the need for treatments that do not suppress the immune system. Immunic Inc. has been exploring new therapies, including a drug that strengthens the bowel barrier. A recent phase two trial with Vidofludimus calcium (IMU-838) in ulcerative colitis showed promising results in maintaining remission. This drug, primarily tested in multiple sclerosis, is part of a class not previously tested in large IBD trials. Another promising drug, IMU-856, aims to regenerate the bowel barrier, preventing harmful interactions between gut bacteria and the immune system without immunosuppression. This drug has shown positive results in animal experiments as well as in healthy volunteers and celiac disease trials. Immunic currently evaluates potential testing of IMU-856 in IBD. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

May 17, 2024 02:35 PM Eastern Daylight Time

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Tackling Childhood Peanut Allergies

YourUpdateTV

Right now, more children in the U.S. are living with peanut allergy than ever before, and approximately 75% will not outgrow their allergy. Recently, Pediatric Allergist, Dr. Douglas Mack, and Sarah Korieshi, the Mother of a peanut allergic child, participated in a nationwide satellite media tour to discuss the impact on children and innovative new treatment options that can help. A video accompanying this announcement is available at: https://youtu.be/5uKicnsGHv8 The repercussions of this condition are profound, extending beyond mere dietary restrictions to impacting a child's daily life, social interactions, and overall well-being. The constant fear of accidental exposure and the potential for severe allergic reactions can also be extremely difficult for families to navigate. The increase in prevalence over the past 20 years has driven a growing need for effective treatment options to manage the condition. For doctors, that means treatments that reduces the likelihood of an allergic reaction in the case of accidental exposure, and treatments that work within the lifestyle of the child and family. The good news is that recent years have brought about a spate of new innovations in the allergy space. For example, there is currently an ongoing clinical trial evaluating Viaskin TM Peanut, a patch containing the equivalent of one one-thousandth of one peanut kernel. The patch is applied each day to a child’s back in order to build up a tolerance to peanut protein, making it less likely that a child will have a reaction after an accidental exposure. For parents, a treatment like this would be life-changing, as a non-invasive option – something that can be incorporated into our busy lives, without any restrictions to regular activities. Having access to a treatment option that allows children and parents to participate in typical activities for a child, such as birthday parties, sports activities, attending camp, or even school, would give parents peace of mind and children the care-free life they deserve. For more information, visit vitesseallergystudy.com About Dr. Douglas Mack Dr. Mack is co-author of clinical guidelines on the prevention of allergy, oral immunotherapy and anaphylaxis and focuses on oral immunotherapy for food at Halton Pediatric Allergy clinic. Dr. Douglas Mack has been a pediatric allergy, asthma, and immunology specialist for over 10 years. Dr. Mack is an assistant clinical professor in the Department of Pediatrics at McMaster University and is an affiliate of Sick Kids. He sits on the board of directors at the Canadian Society of Allergy and Clinical Immunology. He is co-author of clinical guidelines on the prevention of allergy, oral immunotherapy, and anaphylaxis. Dr. Mack is co-founder of Halton Pediatric Allergy clinic where his focus is on oral immunotherapy for food. About Sarah Korieshi Sarah learned that her daughter Zara had a deadly peanut allergy when she was just 9 months old. The first thing she thought was, not only how life-threatening eating a food can be, but also living with the constant fear of what may happen every time she eats. There has always been constant fear with how unpredictable a reaction can be, and the anxiety that comes with solely relying on avoidance really takes a toll. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

May 17, 2024 10:09 AM Eastern Daylight Time

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Elevai Labs (NASDAQ: ELAB) Acquires Rights To Develop Muscle Loss Prevention Assets For Anticipated Use In Anti-Obesity Treatments, Launches Two New Subsidiaries

Benzinga

By James Blacker, Benzinga Some 42% of adults in the United States are affected by obesity, according to the U.S. CDC. At a global level, a new study released by the journal Lancet reveals that around 1 billion people are now living with obesity, with the number of obese adults having doubled since 1990 and quadrupled among children and adolescents. The demand for solutions to escalating obesity rates is only growing. Goldman Sachs Research notes that the global market for anti-obesity drugs reached $6 billion on an annualized basis in 2023 and this global market is projected to experience a more than 16-fold increase to $100 billion by 2030. The global growth of anti-obesity drugs is expected to be led by drugs such as Ozempic ® and Wegovy ®, both manufactured by Novo Nordisk (NYSE: NVO), as well as Mounjaro ®, made by Eli Lilly And Co (NYSE: LLY). However, there are concerns that GLP-1 drugs like Ozempic ® and Wegovy ® might lead to a loss of muscle mass along with fat mass. This potential side effect highlights a need for new or coinciding treatments that can address obesity while limiting such side effects. Revolutionizing Obesity Treatment Medical aesthetics and biopharmaceutical drug development company Elevai Labs Inc. (NASDAQ: ELAB) is working to address this problem. The firm announced on May 2 that it acquired exclusive rights to two new assets that have the potential to limit muscle loss prevention to develop in combination with GLP-1 obesity treatments – namely “EL-22”, a clinical-stage engineered probiotic expressing myostatin, and “EL-32”, a preclinical engineered probiotic expressing dual myostatin & activin-A. “We believe the adoption and use of other GLP-1 drugs […] increases the desire for related aesthetic procedures linked to the side effects from these drugs, including significant unwanted muscle loss. We see the licensing of these two assets as an opportunity to provide an unmet need in the anti-obesity drug market and expand our brand into a large and growing multi-billion-dollar market,” said Elevai Labs CEO Jordan R. Plews. Elevai plans to test how effective and safe EL-22 is in combination with weight-loss medications currently available on the market. It expects to submit an Investigational New Drug application to the FDA in 2025 and hopes to initiate clinical trials in the U.S. soon thereafter. New Subsidiaries In line with its growth in the biotech industry, Elevai Labs announced on May 1 it launched two new wholly-owned subsidiaries — Elevai Biosciences and Elevai Skincare. Elevai Biosciences will focus on acquiring and developing cutting-edge aesthetic medicines, with EL-22 as its lead asset. Elevai Skincare is a new entity that will continue to advance the company’s skincare solutions. The company hopes that the reorganization of its skincare operations will boost focus, agility, and market penetration in order to capitalize on emerging opportunities in the medical aesthetics skincare market. Commenting on the announcement, Co-founder and CEO Jordan R. Plews stated, “The launch of Elevai Biosciences, Inc. and Elevai Skincare, Inc. as wholly-owned operating subsidiaries signifies a significant milestone in our journey towards reshaping the future of medical aesthetics and biotech. With Elevai Biosciences, we believe we are poised to lead the development of next-generation aesthetic medicines, while Elevai Skincare will continue to develop and deliver exceptional cosmetic solutions to our customers worldwide.” Featured photo by Prostock-studio on Shutterstock. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. Cautionary Note Regarding Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "believes," "expects," "plans," "potential," "would" and "future" or similar expressions such as "look forward" are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Elevai's expectations regarding its growth, strategy, progress and the design, objectives and timing of its clinical trials for EL-22; and the potential of EL-22 to treat obesity without an associated loss of muscle, both as a monotherapy and in combination with GLP-1 receptor agonists. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Elevai's limited operating history and historical losses; Elevai's ability to raise additional funding to complete the development and any commercialization of its product candidates; Elevai's dependence on the success of its product candidates EL-22 and EL-32; that Elevai may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Elevai's ability to obtain, maintain and protect its intellectual property; and Elevai's dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. These and other risks are described more fully in Elevai's filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

May 17, 2024 08:45 AM Eastern Daylight Time

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Neural Therapeutics CEO Ian Campbell discusses potential CSE listing and future plans

Neural Therapeutics Inc.

Neural Therapeutics CEO Ian Campbell discusses the company's conditional approval to list on the Canadian Securities Exchange (CSC) in an interview with Proactive's Stephen Gunnion. Campbell explained that the CSE listing is a strategic move, enabling broader market participation and capitalisation on its advancements. The company aims to raise $500,000, primarily for research and development efforts and securing intellectual property, including two patents. Campbell highlighted the growing interest in psychedelic treatments, noting the significant investment in this sector and the 44% rise of the Psychedelic Invest Index this year. He emphasised the mental health crisis and the inadequacy of outdated therapies, positioning psychedelics as a promising and disruptive alternative. Neural Therapeutics specialises in mescaline extracted from the San Pedro cactus, a substance with a long history of safe use. Campbell noted mescaline's unique properties, such as its longer duration in the body, which supports neuroplasticity and potential treatment for mental illnesses like addiction without causing hallucinations. The CSE listing is expected to enhance the company's visibility, attract investment, and accelerate drug development. Contact Details Proactive United States +1 347-449-0879 action@proactiveinvestors.com

May 17, 2024 08:00 AM Eastern Daylight Time

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Arecor Therapeutics reports strong 2023 results and outlines expanding product pipeline

Arecor Therapeutics PLC

Arecor Therapeutics PLC (AIM:AREC)C CEO Sarah Howell discusses the company's 2023 performance and future plans with Proactive's Stephen Gunnion. Howell highlighted that Arecor has seen significant growth, particularly with the launch of products incorporating its Arestat technology under a global licensing agreement, generating royalties. Six new technology partnerships were established with major pharma and biotech companies, offering potential for future licensing and market development. Arecor focuses on diabetes and obesity, with clinical results for their proprietary product, AT278, expected soon. This highly concentrated, rapid-acting insulin aims to provide better glucose control for type 2 diabetics with high BMI and support the next generation of insulin pump devices. Tetris Pharma, a subsidiary, has shown strong growth under new leadership, with product sales tripling to £2.9 million in 2023. Its lead product, glucagon, has contributed significantly to this growth. Howell also noted the importance of technology partnerships and licensing programs. Arecor has entered into three active license programs and is progressing well with its partners. One notable partnership is with Medtronic to develop a concentrated, stable insulin for intra-peritoneal delivery, aiming to reduce hospital visits for patients with brittle diabetes. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

May 17, 2024 03:20 AM Eastern Daylight Time

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Immunic highlights IMU-856 gastrointestinal candidate to mark International Celiac Day

Immunic Inc

Immunic Inc (NASDAQ:IMUX) chief scientific officer Hella Kohlhof joined Proactive's Stephen Gunnion on International Celiac Day, in the middle of Celiac Disease Awareness Month, to discuss the disease and the company’s developments in treating it. Kohlhof explained that celiac disease is a severe autoimmune disorder affecting around 1% of the global population, predominantly females. Unlike gluten intolerance, celiac disease involves an immune reaction to gluten, leading to gut inflammation and destruction. The only current treatment is a gluten-free diet, which is not effective for all patients. Kohlhof elaborated on the disease's scientific background, highlighting its genetic association with specific HLA genotypes (HLA-DQ2 and HLA-DQ8). She explained that celiac disease is triggered by the immune system's reaction to deaminated gluten peptides, causing inflammation and damage to the gut lining. Immunic is developing IMU-856, an epigenetic modulator, to treat gastrointestinal diseases like celiac disease. IMU-856 enhances gut regeneration and strengthens the gut barrier, improving patients' conditions. Kohlhof detailed the successful completion of a Phase 1b study in celiac patients, which demonstrated the drug’s safety, good pharmacokinetic properties, and positive effects on symptoms, biomarkers, gut histology, and nutrient uptake during a gluten challenge. The study confirmed the potential of IMU-856 in treating celiac disease, and further exploration of its mode of action is ongoing. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

May 16, 2024 05:54 PM Eastern Daylight Time

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Meritage Wealth Insurance Advisors Joins Forces with AmeriLife’s Saybrus Partners

AmeriLife

Saybrus Partners (“Saybrus”), a market leader in life and annuity distribution and an affiliate of AmeriLife Group, LLC (“AmeriLife”), announced today that it has entered into a partnership with Meritage Wealth Insurance Advisors (“Meritage”), a point-of-sale (POS) focused, national life insurance general agency that serves financial professionals across a spectrum of life, annuity, retirement, legacy and business/executive benefits planning solutions. Per the agreement, terms of the deal were not disclosed. “Meritage Wealth Insurance Advisors’ experience and success in the life insurance industry, sophisticated planning expertise, and strong operational capabilities make the firm an exciting complement to our business,” said Edward W. Cassidy, managing principal of Saybrus Partners. “I’m happy to welcome Meritage’s leadership team and employees to the Saybrus family, and look forward to our work together.” Founded in 2019 by a team of five industry veterans, Meritage has built a national reputation for expertly designed solutions and consistently exceeding expectations for the most sophisticated and complex client relationships. Among other capabilities, including point-of-sale support, Meritage’s full-service model offers access to advanced case design, deep carrier relationships and product options, and back-office and underwriting support. With over 100 years of combined experience, Meritage’s partners have built a company that is passionate about client service delivered through a high-touch, consultative approach that has helped the firm stand apart in the industry. “We are thrilled to be joining this industry-leading organization,” said Chuck Adam, one of Meritage’s founding partners. “Not only did we immediately connect with Saybrus’ culture and team, but the company’s strong track record, robust resources and long-standing relationships make it a great strategic fit for our firm.” Together with Saybrus, Meritage also becomes part of a fast-growing AmeriLife Wealth Group, a new kind of wealth distribution platform that aims to deliver a suite of best-in-class services to the modern agent and financial professional to ensure their clients – no matter their stage of life – never outgrow them. “Meritage brings all the components we look for in new wealth distribution partners and we’re thrilled to welcome them to the AmeriLife family of companies,” said Mike Vietri, Chief Distribution Officer for AmeriLife Wealth Group. “Indeed, Meritage is the perfect complement to Saybrus, and I have no doubt that – with the support of Ed and his team – Meritage will take an already stellar track record of growth and success to new heights.” Under Saybrus, the firm will continue to operate as a standalone company from its Cypress, Texas headquarters, led by its five founding partners who will report to Cassidy. ### About Meritage Wealth Insurance Advisors Meritage is a National Insurance General Agency with full support for client advisors managing important, sophisticated client relationships. Partnering with private and institutional practices, its team brings expertise in Family Planning, Legacy Planning, Retirement Planning and Business Planning. The firm’s comprehensive capabilities comprise point of sale consultation, advanced case design access, solutions from numerous life insurance carriers, high-end underwriting expertise and experienced case facilitation. For more information, visit www.meritagewia.com. About Saybrus Partners Saybrus Partners, LLC helps institutions and financial professionals address clients' needs with insurance and annuity solutions for basic protection as well as retirement, estate and business planning. Its partner firms include institutional financial advisories, insurance retailers, banks and broker/dealers. Customizing its services to best fit its partners' businesses, the company offers a complete set of distribution capabilities including assisted sales, traditional wholesaling, new business operations and custom product design. For more information, visit www.saybruspartners.com and follow Saybrus on LinkedIn. About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as the leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For more than 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers served through a distribution network of over 300,000 insurance agents and financial professionals and more than 100 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com, and follow AmeriLife on Facebook and LinkedIn. Contact Details Media Jeff Maldonado media@amerilife.com Partnership Inquiries Patrick Nichols corporatedevelopment@amerilife.com Company Website https://amerilife.com/

May 16, 2024 09:00 AM Eastern Daylight Time

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