Mirikizumab

The Phase 3 VIVID-1 trial evaluated the safety and efficacy of Omvoh in patients with or without prior biologic failure and was the basis for the positive opinion VIVID-1 was the first pivotal Crohn's disease trial to show benefits in hard-to-treat symptom of bowel urgency using a patient-centric scale Omvoh will be the first treatment for Crohn's disease with results demonstrating improvements of histologic measures of inflammation included in its label, if approved by the European Commission Lilly has also submitted Omvoh in the U.S. for approval to treat adults with moderately to severely active Crohn's disease, with a decision expected in the first half of 2025 INDIANAPOLIS, Dec. 13, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Omvoh® (mirikizumab), an interleukin-23p19 (IL-23p19) antagonist, for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment. "I am excited for the potential of Omvoh as a novel treatment option for patients suffering from moderately to severely active Crohn's disease, since the majority of patients do not achieve remission on current therapies or cannot maintain it long term," said Stefan Schreiber, M.D., Ph.D., director of the Clinic for Internal Medicine I at Kiel Campus of the University Hospital Schleswig-Holstein, Kiel, Germany. "With Omvoh, many patients can achieve comprehensive control of their disease, including relief from disruptive symptoms such as bowel urgency and control of intestinal inflammation defined by visible endoscopic and histologic healing." Omvoh was previously approved in the European Union, U.S. and Japan in 2023 as a first-in-class treatment for adults with moderately to severely active ulcerative colitis (UC) and is approved in 44 countries around the world. This positive opinion marks the next step toward European regulatory approval of Omvoh for patients with moderately to severely active Crohn's disease, and it is now referred to the European Commission for final action. The European Commission's decision is expected in the next one to two months. The positive CHMP opinion is supported by data from the Phase 3 VIVID-1 study evaluating the safety and efficacy of mirikizumab compared with placebo and an active control (ustekinumab) in adults with moderately to severely active Crohn's disease. In VIVID-1, patients treated with mirikizumab achieved statistically significant improvement compared to placebo-treated patients on both co-primary endpoints, composite endoscopic response and composite clinical remission, and all major secondary endpoints, including composite steroid-free clinical remission and endoscopic outcomes, at Week 12 and Week 52. Additionally, improvements in bowel urgency severity were achieved, as measured by a patient-centric, 11-point scale developed by Lilly. VIVID-1 is the first pivotal Crohn's disease trial to report improvements in histologic outcomes with strict definitions that were aligned with the European Crohn's and Colitis (ECCO) position statement on mucosal histopathology. Histologic healing, as evaluated by these histologic measures of inflammation, is associated with better long-term outcomes for patients with Crohn's disease. Mirikizumab's overall safety profile in patients with moderately to severely active Crohn's disease was consistent with its known safety profile in patients with UC. Results from the VIVID-1 study were recently published in The Lancet. In addition, long-term, multi-year, sustained efficacy and safety data for both UC and Crohn's disease were also recently presented at the American College of Gastroenterology (ACG) Annual Meeting in October. "Disruptive symptoms of Crohn's disease, such as bowel urgency, can interfere with all aspects of life, leaving many people searching for treatments that can help them fully participate in the things that they enjoy," said Mark Genovese, M.D., senior vice president of Lilly Immunology development. "Given the efficacy we saw on clinical remission and endoscopic response, combined with the improvements in bowel urgency and histological inflammation, this positive CHMP opinion for Omvoh brings us a step closer to advancing care for more people with inflammatory bowel disease around the world." Lilly has submitted marketing applications for Omvoh in Crohn's disease around the globe, including the U.S. and Japan. Decisions are expected from these regulatory authorities starting in the first half of 2025. About Crohn's Disease Crohn's disease is a chronic, inflammatory bowel disease associated with progressive bowel damage, disability and decreased health-related quality of life. If not adequately controlled, it may lead to complications that require hospitalization and surgical intervention. A substantial proportion of patients do not experience adequate treatment outcomes, have secondary loss of response to maintenance therapy or do not tolerate existing therapies, including biologic agents. Patients with previous biologic failure may be more difficult to treat. About VIVID-1 VIVID-1 was a Phase 3, randomized, double-blind, treat-through study that evaluated the safety and efficacy of mirikizumab compared with placebo and an active control (ustekinumab) in adults with moderately to severely active Crohn's disease. Patients randomized to mirikizumab were administered 900 mg of mirikizumab intravenously at Week 0, 4 and 8, then 300 mg subcutaneously every four weeks from Weeks 12-52. In this study, 49% of patients taking mirikizumab or placebo had experienced a prior biologic failure. Indications and Usage for Omvoh® (mirikizumab-mrkz) (in the United States) Omvoh® is indicated for the treatment of moderately to severely active ulcerative colitis in adults. Important Safety Information for Omvoh (mirikizumab-mrkz) CONTRAINDICATIONS - Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with Omvoh administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction. If a severe hypersensitivity reaction occurs, discontinue Omvoh immediately and initiate appropriate treatment. Infections Omvoh may increase the risk of infection. Do not initiate treatment with Omvoh in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing Omvoh. Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer Omvoh until the infection resolves. Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Omvoh. Do not administer Omvoh to patients with active TB infection. Initiate treatment of latent TB prior to administering Omvoh. Consider anti-TB therapy prior to initiation of Omvoh in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after Omvoh treatment. In clinical trials, subjects were excluded if they had evidence of active TB, a history of active TB, or were diagnosed with latent TB at screening. Hepatotoxicity Drug-induced liver injury in conjunction with pruritus was reported in a clinical trial patient following a longer than recommended induction regimen. Omvoh was discontinued. Liver test abnormalities eventually returned to baseline. Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment. Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction. Immunizations Avoid use of live vaccines in patients treated with Omvoh. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or non-live vaccines in patients treated with Omvoh. ADVERSE REACTIONS Most common adverse reactions (≥2%) associated with Omvoh treatment are upper respiratory tract infections and arthralgia during induction, and upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection during maintenance. During induction, Omvoh is available as a single dose vial for intravenous infusion containing 300 mg/15 mL that is administered in a healthcare facility. During maintenance, Omvoh is available as a one-time use prefilled pen or syringe with 100 mg/mL for subcutaneous injections. See Prescribing Information for dosing information. MR HCP ISI 31JUL2024 Please click for Prescribing Information and Medication Guide for Omvoh. Please click for Instructions for Use included with the device. About Omvoh® Omvoh® (mirikizumab) is an interleukin-23p19 antagonist indicated for the treatment of moderately to severely active ulcerative colitis in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of ulcerative colitis. Treatment of ulcerative colitis with Omvoh starts with 300-mg IV infusions, once every four weeks for a total of three infusions, and transitions to two, 100-mg subcutaneous injections every four weeks during maintenance treatment. Omvoh® and its delivery device base are trademarks owned by Eli Lilly and Company. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Omvoh (mirikizumab-mrkz) as a potential treatment for people with moderate to severe Crohn's disease and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Omvoh will receive additional regulatory approvals, or that Omvoh will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. SOURCE Eli Lilly and Company WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HERZLIYA, Israel and CALGARY, Alberta, Dec. 12, 2024 /PRNewswire/ -- Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) (the "Company" or "Innocan") a pharmaceutical technology company focusing on developing innovative drug delivery platform technologies and an owner of a proprietary intellectual property portfolio, is pleased to share its annual "State of Research and Development" update for 2024. This year, the Company achieved significant milestones in advancing research and development for its drug delivery platforms as well as its intellectual property portfolio. During 2024, Innocan achieved significant milestones in both scientific and regulatory domains. Preclinical studies of its liposome-cannabidiol technology (LPT-CBD( demonstrated high CBD bioavailability, along with long-lasting pain relief and improved well-being in various animal models. Building on this compelling data, the Company secured agreement from the United States Food and Drug Administration (FDA) on the preclinical and Phase 1 clinical development plan to advance LPT-CBD as a treatment for chronic pain in humans. Additionally, the FDA acknowledged LPT-CBD's development under the 505(b)(2) regulatory pathway, which provides Innocan with an accelerated route to patent utilization and commercialization. On the veterinary front, LPT-CBD's innovation was recognized by the FDA's Center for Veterinary Medicine (CVM), which granted Innocan a fee waiver for 2024 and issued a number that identifies an Investigational New Animal Drug (INAD). This designation allows Innocan to facilitate correspondence and data exchange with the CVM to support the development of LPT-CBD as a new veterinary drug. Iris Bincovich, CEO of Innocan Pharma, commented: "In 2024, we not only met but surpassed our FDA-related goals, achieving regulatory milestones ahead of schedule. With the FDA 505(b)(2) regulatory pathway meeting behind us, these advancements position us to accelerate our development in 2025, bringing us closer to delivering innovative pain management solutions for both human and veterinary applications." The 505(b)(2) FDA regulatory pathway offers a streamlined approach for developing a long-acting injectable cannabinoid using a liposomal drug delivery platform to treat chronic pain. By leveraging existing pre-clinical data from approved products, this pathway is expected to significantly shorten both development time and cost. This pathway facilitates innovative formulations like liposomal delivery, by allowing for modifications to dosage forms, administration routes, or drug combinations, all while adhering to stringent safety and efficacy standards. This approach is expected to accelerate market entry and address unmet medical needs in chronic pain management. Company' s Update on its Activity in Research and Development and FDA interactions On February 26, 2024, the Company announced the latest findings from the Company's pharmacokinetic study of its liposome CBD platform ("LPT-CBD") in rabbits. In agreement with studies conducted in other animals (mice, dogs, goats, and sheep) this study resulted in prolonged exposure of CBD obtained following a single subcutaneous LPT-CBD injection. This data along with data obtained from other organisms injected with the Company's liposomal CBD, consistently demonstrates that a detectable CBD level could be maintained for weeks following a single injection. On March 5, 2024, the Company announced the results of a recent tissue distribution study of its liposome CBD platform (LPT-CBD), that indicated the potential of LPT-CBD to support a new therapeutic venue for neurological disorders. In this study, CBD was found to be in the brains of both mice and rabbits weeks after LPT-CBD was subcutaneously injected to them. LPT technology provides a long presence of CBD in the blood enabling CBD to pass the blood brain barrier (BBB) and deliver long brain exposure. On April 22, 2024, the Company announced that it had submitted its letter of application for a Pre-IND meeting, the first phase in the FDA approval process in the United States for LPT-CBD. Innocan's Pre-IND meeting request letter to the FDA represents a key milestone and important first step in seeking approval of its LPT-CBD therapy for use in humans. The objective of the Pre-IND meeting is to obtain guidance from the FDA on the preclinical and clinical development plan, enabling the initiation of an investigational new drug ("IND") program in the United States. On May 9, 2024, the Company announced the successful pre-clinical treatment of amputee female donkey with a liposomal-CBD injection. Miri, a-7-year-old female donkey, had undergone amputation of her right front limb, leaving the weight burden primarily on her left front limb. This led to an inflammatory disease affecting the soft tissue that connects the foot bone to the hoof, seemingly causing extreme pain and limited mobility. In a compassionate act, Miri was administered a liposomal-CBD injection. The effect was immediate as Miri regained her ability to walk and move as she had before her inflammatory disease developed. On May 21, 2024, the Company announced significant advancements in the regulatory process for its LPT-CBD, which provides an innovative solution in non-opioid pain management. The FDA granted Innocan an INAD number and approved an initial meeting with the Company to discuss the strategic path forward. The meeting with the FDA was on July 31, 2024, where Innocan presented its preclinical results and proposed clinical development plan. The meeting is key to launching human clinical trials for the LPT-CBD injectable drug, developed to provide a novel treatment option for chronic pain. On June 11, 2024, the Company announced the success and conclusion of a preliminary safety evaluation of Innocan's single injection and sustained-release LPT-CBD conducted on minipigs. Recognized by the FDA as an excellent model for toxicology, minipigs are small breeds of miniature domestic pigs which share strong similarities with humans in crucial aspects such as drug metabolism, skin structure, genetics, and physiological mechanisms. In this preliminary safety study, minipigs received a single subcutaneous injection of LPT-CBD and were closely monitored for pharmacokinetics and basic safety parameters over one month. The animals all exhibited good drug tolerance and did not manifest any drug-related adverse reactions. On July 2, 2024, the Company announced that it engaged the Past President of the Eastern Pain Association, Dr. William K. Schmidt, to support its LPT-CBD submission process to the FDA for chronic pain. His extensive expertise in pain-related clinical development and regulatory affairs will strongly contribute to Innocan's team during the LPT-CBD submission process with the FDA. Dr. Schmidt brings over 25 years of pharmaceutical industry clinical trial experience, specializing in analgesic and narcotic antagonist drug development. On July 26, 2024, the Company announced that the CVM) granted the Company a sponsor fee waiver and assigned an INAD number for its LPT-CBD product. This represented a significant step for the Company, as an INAD designation facilitates correspondence and data exchange with CVM to support LPT-CBD development as a new veterinary drug. The Company further announced that following the assessment of LPT-CBD's scientific package, the CVM recognized Innocan's contribution to pursuing innovative animal drug products and technology and granted the Company a sponsor fee waiver for fiscal year 2024. Over the past year, repeated administration of LPT-CBD in dogs and other animals demonstrated both efficacy and tolerability, providing sufficient evidence for the INAD application. On September 3, 2024, the Company announced that it received a positive response from the FDA following Innocan's successful pre-IND Type B meeting with the FDA held in July, for its lead drug product LPT-CBD. The FDA has agreed to LPT-CBD's submission under the 505(b)(2) New Drug Application (NDA) by establishing a scientific bridge to the reference listed drug. The 505(b)(2) abbreviated pathway, as it is often described, typically enables a faster route to patent utilization and commercial approval. This pathway is a significant milestone for Innocan, as it may pave the way for a streamlined and accelerated FDA approval process for LPT-CBD, while allowing Innocan to advance its patent protected innovation. In addition, Innocan has reached an alignment with the FDA on both its non-clinical development plan and the clinical study design for LPT-CBD's proposed IND filing for a Phase I clinical study. On October 9, 2024, The Company announced that Dr. Joseph V. Pergolizzi, Jr., M.D., a member of the Company's Scientific Advisory Board, was recognized among the top 2% most cited scientists in the world in a new list published by Stanford University. This achievement underscores Dr. Pergolizzi's long-term contribution to medical science and his influential role in shaping global healthcare practices. Dr. Pergolizzi was appointed to be part of Innocan's Scientific Advisory Board in September 2023. His role focuses on promoting pharmaceutical human product R&D and supporting the Company's planned FDA filing for new medications. His expertise in pain management, critical care medicine, and regulatory processes are key in advancing the issuer's pharmaceutical developments. On October 11, 2024, the Company announced promising results from a multi-year compassionate therapy using repeated LPT-CBD injections for pain relief in dogs with naturally occurring osteoarthritis. The therapy consistently demonstrated pain reduction and improved mobility, with effects lasting for several weeks after each injection as expected. These results further demonstrate that LPT-CBD can be a viable treatment option for managing chronic pain and enhancing the quality of life in animals. In two ongoing cases, dogs suffering from osteoarthritis who were treated with LPT-CBD after failing to respond to non-steroidal anti-inflammatory drugs (NSAIDs) and oral CBD, showed noticeable pain relief, substantially improved mobility and increased well-being which was clearly noticeable. Both dogs remained on LPT-CBD treatment for 2 and 2.5 years, respectively after their owners reported significant improvement in quality of life, receiving the treatment in addition to other conventional treatments. About Innocan Innocan is an innovator in the pharmaceuticals and wellness sectors. In the pharmaceuticals sector, Innocan developed a CBD-loaded liposome drug delivery platform with exact dosing, prolonged and controlled release of synthetic CBD for non-opioid pain management. In the wellness sector, Innocan develops and markets a wide portfolio of high-performance self-care and beauty products to promote a healthier lifestyle. Under this segment Innocan carries on business through its 60% owned subsidiary, BI Sky Global Ltd. which focuses on advanced, targeted online sales. For further information, please contact: Iris Bincovich, CEO +1-516-210-4025 +972-54-3012842 +44 203 769 9377 [email protected] NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE. Cautionary note regarding forward-looking information Certain information set forth in this news release, including, without limitation, information regarding research and development, collaborations, the filing of potential applications with the FDA and other regulatory authorities, the potential achievement of future regulatory milestones, the potential for treatment of conditions and other therapeutic effects resulting from research activities and/or the Company's products, requisite regulatory approvals and the timing for market entry and potential for patent utilization and commercialization is forward-looking information within the meaning of applicable securities laws. By its nature, forward-looking information is subject to numerous risks and uncertainties, some of which are beyond Innocan's control. The forward-looking information contained in this news release is based on certain key expectations and assumptions made by Innocan, including expectations and assumptions concerning the anticipated benefits of the products, satisfaction of regulatory requirements in various jurisdictions and satisfactory completion of requisite production and distribution arrangements. Forward-looking information is subject to various risks and uncertainties which could cause actual results and experience to differ materially from the anticipated results or expectations expressed in this news release. The key risks and uncertainties include but are not limited to: general global and local (national) economic, market and business conditions; governmental and regulatory requirements and actions by governmental authorities; and relationships with suppliers, manufacturers, customers, business partners and competitors. There are also risks that are inherent in the nature of product distribution, including import / export matters and the failure to obtain any required regulatory and other approvals (or to do so in a timely manner) and availability in each market of product inputs and finished products. The anticipated timeline for entry to markets may change for a number of reasons, including the inability to secure necessary regulatory requirements, or the need for additional time to conclude and/or satisfy the manufacturing and distribution arrangements. As a result of the foregoing, readers should not place undue reliance on the forward-looking information contained in this news release concerning the timing of launch of product distribution. A comprehensive discussion of other risks that impact Innocan can also be found in Innocan's public reports and filings which are available under Innocan's profile at . Readers are cautioned that undue reliance should not be placed on forward-looking information as actual results may vary materially from the forward-looking information. Innocan does not undertake to update, correct or revise any forward looking information as a result of any new information, future events or otherwise, except as may be required by applicable law. Logo - SOURCE Innocan Pharma Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED