Insulin human(Eli Lilly & Co.)

Arecor Therapeutics plc(“Arecor” or “the Company”) AT278 ULTRA-CONCENTRATED ULTRA-RAPID ACTING INSULIN DEMONSTRATES SUPERIORITY IN PHASE I CLINICAL TRIAL IN OVERWEIGHT AND OBESE PEOPLE WITH TYPE 2 DIABETES AT278 demonstrates significantly accelerated PK/PD profile compared to NovoRapid® and Humulin® R U-500 in people with Type 2 Diabetes and high BMIConfirms previous trial results in people with Type 1 diabetes, demonstrating AT278 can maintain fast and superior onset of action and glucose lowering profile irrespective of diabetes type and BMIEnables delivery of a highly concentrated, low volume injection, offering more effective mealtime glucose control to meet growing unmet need in patients requiring high daily doses of insulin Creates potential to be the first, and only, ultra-concentrated (500 U/mL) ultra-rapid insulin product enabling miniaturisation of next-generation insulin pumpsCompany will host a CEO and key opinion leader webinar to discuss the results on Tuesday 21 May at 14.30 BST Cambridge, UK, 20 May 2024. Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical group advancing today’s therapies to enable healthier lives, today announces that its ultra-concentrated, ultra-rapid acting insulin candidate, AT278, met all primary and secondary endpoints, and also demonstrated superiority to NovoRapid® and Humulin® R U-500, in a Phase I clinical trial in Type 2 diabetics with a high body mass index (BMI). AT278 (500 U/mL) is an ultra-concentrated, ultra-rapid acting, novel formulation of insulin that accelerates the absorption of insulin post injection, even when delivered at a high concentration, and hence a lower injection volume. With no concentrated (>200 U/mL), rapid acting insulins on the market, AT278 has potential to be the first, and only, insulin available to the growing number of patients with high daily insulin requirements. Sarah Howell, Chief Executive Officer of Arecor, said: "We are delighted with the clinical results from this second Phase I study, demonstrating AT278’s superiority over NovoRapid® and Humulin® R U-500 in Type 2 diabetics with a high BMI. They further add to the positive results from our previous clinical study in Type 1 diabetic patients, where superiority was also demonstrated. This is a significant step in AT278’s development and extends our confidence in its clear potential to provide a superior insulin treatment option that lowers burden and improves outcomes for people living with diabetes who require high daily doses of insulin. Such patients make up a large segment of the target market. In addition, as the only concentrated, yet very rapid acting, insulin in development, AT278 has the capability to disrupt the market by enabling the next generation of truly miniaturised, longer-wear insulin pumps, a key focus for patients, physicians and the industry.” Many Type 2 diabetics with a high BMI are currently not well controlled, and improved treatments options such as AT278 are needed to reduce patient burden through fewer injections per day, reduced injection volumes and dosing flexibility around mealtimes. This lowering of burden for patients improves treatment adherence and, allied with AT278’s superior efficacy, should improve both blood glucose control and outcomes. In addition, a truly ultra-rapid, ultra-concentrated insulin is a critical step towards next-generation miniaturised and long-wearing insulin pumps, which are predicted to transform future diabetes management. Professor Thomas Pieber, Principal Investigator for the ARE-278-104 clinical trial, said: “These results are highly significant, AT278 has clearly demonstrated faster insulin absorption with an accelerated Pharmacokinetic (PK) and Pharmacodynamic (PD) profile compared to the lower concentration standard insulin aspart (NovoRapid®). The PK/PD profile of AT278 (500 U/mL) was also greatly accelerated compared to Humulin® R U-500 (500 U/mL). Together with its superior profile in the earlier Phase I clinical study in Type 1 diabetic patients1 AT278 has demonstrated its ability to maintain a fast and superior onset of action and glucose lowering profile irrespective of diabetes type and BMI. This makes AT278 completely unique in the competitive field of insulin analogues. Not only does it have the potential to significantly improve post-prandial glucose control whilst lowering burden for anybody with diabetes who has a high daily insulin need, it can act as a catalyst in the development of miniaturised insulin delivery systems, where the size of existing devices is a significant barrier to use for many patients.” In the double-blind, randomised, two-way crossover study, the pharmacokinetic (PK)/pharmacodynamic (PD) and safety profiles of a single subcutaneous (SC) dose of 0.5 U/kg AT278 (500 U/mL) were compared with those of a single SC dose of 0.5 U/kg NovoRapid® (100 U/mL), a currently available gold standard, rapid acting insulin treatment, in 39 participants with Type 2 diabetes within a BMI range of 25 and 39 kg/m2, in a euglycemic clamp setting. The PK/PD profile of 0.5 U/kg AT278 (500 U/mL) was also compared to a single SC dose of 0.5U/kg Humulin® R U-500 (500 U/mL) in an open label manner. The trial met the primary endpoint of non-inferiority with respect to glucose lowering actions compared with NovoRapid®AT278 (500 U/mL) demonstrated a significantly accelerated (superior) early PK/PD profile compared to NovoRapid® (100 U/mL), despite a 5-fold increase in concentrationAT278 (500 U/mL) demonstrated a significantly accelerated (superior) PK/PD profile compared to Humulin® R U-500 (500 U/mL), the only other insulin available at a concentration of 500 U/mL No safety signals were detected With around 537m people living with diabetes worldwide, there are growing numbers of people who require insulin to manage their blood glucose and, for many, their diabetes is still poorly controlled. There is a growing need for highly concentrated, much faster, and more physiological insulins to effectively manage diabetes. In the US alone, nearly 10% of insulin scripts written in 2022 were for products with a concentration of >100 U/mL2. Furthermore, despite the improvements in outcomes among people with diabetes who use insulin pumps and automated delivery systems, they are still only used by less than 40% of people with Type 1 diabetes and less than 10% of people with Type 2 diabetes in the US3. The size and short duration of wear of existing insulin pumps remains a significant barrier to use. AT278 has the potential to be the only highly concentrated, ultra-rapid acting insulin to enable the next generation of miniaturised, longer wear insulin pumps. The insulin pump market is valued at circa $5.5bn market today4, with a significant opportunity for substantial growth in this market by expanding use across the Type 1 and Type 2 patient population that can be further enabled by AT278 and a next generation insulin pump. A full analysis of the trial data is now underway to enable the Company to determine and pursue a strategy for AT278 that maximises value for shareholders and patients. Detailed data from the trial will be submitted for publication and presentation at a future international diabetes conference. AT278 clinical results CEO and KOL webinar - Tuesday 21 MayDr Sarah Howell, Chief Executive Officer, and Professor Thomas Pieber, Principal Investigator for the ARE-278-104 clinical trial and Professor of Medicine, Head of the Division of Endocrinology and Metabolism and Chairman of the Department of Internal Medicine at Medical University of Graz, Austria will host a CEO and key opinion leader webinar to discuss the clinical results on Tuesday 21 May at 14.30 BST. To register to join the live webcast click here and to register for the conference line to ask questions click here. Please contact ICR Consilium for details on arecor@consilium-comms.com. This announcement contains inside information for the purposes of the retained UK version of the EU Market Abuse Regulation (EU) 596/2014 ("UK MAR"). -ENDS- References Pharmacokinetics and Pharmacodynamics of a Novel U500 Insulin Aspart Formulation: A Randomized, Double-Blind, Crossover Study in People With Type 1 Diabetes Care 2023;46(4):757–764: https://doi-org.libproxy1.nus.edu.sg/10.2337/dc22-10542022 reports from Symphony. Retrieved October 2023Seagrove Partners Diabetes Bluebook 2022Insulin pump company annual reports and Company estimates For more information, please contact: Arecor Therapeutics plcwww.arecor.comDr Sarah Howell, Chief Executive OfficerTel: +44 (0) 1223 426060Email: info@arecor.com Susan Lowther, Chief Financial OfficerTel: +44 (0) 1223 426060Email: info@arecor.com Panmure Gordon (UK) Limited (NOMAD and Broker) Freddy Crossley, Emma Earl (Corporate Finance)Rupert Dearden (Corporate Broking)Tel: +44 (0) 20 7886 2500 WG Partners LLP (Financial Advisor) Nigel Barnes, Satheesh NadarajahDavid Wilson, Claes SpangTel: +44 (0)203 705 9321 ICR Consilium Chris Gardner, David Daley, Lindsey NevilleTel: +44 (0) 20 3709 5700Email: arecor@consilium-comms.com Notes to Editors About Arecor Arecor Therapeutics plc is a globally focused biopharmaceutical company transforming patient care by bringing innovative medicines to market through the enhancement of existing therapeutic products. By applying our innovative proprietary technology platform, Arestat™, we are developing an internal portfolio of proprietary products in diabetes and other indications, as well as working with leading pharmaceutical and biotechnology companies to deliver therapeutic products. The Arestat™ platform is supported by an extensive patent portfolio. For further details please see our website, www.arecor.com

Pictured: Eli Lilly world headquarters/iStock, jetcityimage Eli Lilly is looking to bolster the commercial availability of its weight-loss drug Zepbound (tirzepatide) with the launch of a direct-to-consumer website and services to streamline access, the pharma giant announced Thursday. The new digital healthcare site called LillyDirect is designed for patients with obesity, migraines and diabetes. According to the company, the site will offer “disease management resources” giving consumers access to healthcare providers and providing home delivery of Lilly’s medicines through third-party pharmacy dispensing services. “A complex U.S. healthcare system adds to the burdens patients face when managing a chronic disease. With LillyDirect, our goal is to relieve some of those burdens by simplifying the patient experience to help improve outcomes,” Lilly CEO David Ricks said in a statement. By obtaining the medicines—including Zepbound—from the company directly, patients can access “affordability solutions” in the form of saving cards that are automatically applied for patients who qualify, Lilly contends. Medicines that pharmacy service providers fulfill will also ship for free, according to Thursday’s announcement. Other medicines available on the site include Rezvoglar, Humulin, Humalog, Emgality, and Basaglar. LillyDirect will also provide patients with access to telehealth providers and allow for search tools to find healthcare professionals near patients if in-person care is preferred. “We know that people have come to depend on the efficiency and convenience of digital solutions to meet a variety of their everyday needs—healthcare being one of them,” Frank Cunningham, Lilly’s group vice president of global value and access, said in a statement. “We launched LillyDirect with the hope that it will offer patients an innovative end-to-end experience to manage their health and access their medicines so they can get back to living their lives.” Lilly will update the site and include new products, partners, and services in the future. On Thursday, Lilly also released an open letter warning against the use of its GLP-1 drugs Mounjaro and Zepbound for “cosmetic weight loss.” Lilly’s Zepbound injection was approved in November 2023 by the FDA and is meant for adults to manage chronic weight management issues including obesity with at least one weight-related condition such as high cholesterol or hypertension. In December 2023, a study published in the scientific journal JAMA found that patients taking the drug had regained weight after halting treatment. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.