Joint Diseases

CALGARY, Alberta, Jan. 17, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease and gout, announces the Company has changed its auditor from Smythe LLP, Chartered Professional Accountants (“Former Auditor”) to Davidson & Company LLP, Chartered Professional Accountants, (“Successor Auditor”) effective January 16, 2025. XORTX’s board of directors accepted the resignation of the Former Auditor, as of January 16, 2025 and appointed the Successor Auditor as the new auditor of the Company effective January 16, 2025, and to hold office until the close of the Company's next annual general meeting of shareholders. There were no reservations in the Former Auditor's audit reports for any financial period during which the Former Auditor was the Company's auditor. There are no "reportable events" (as the term is defined in National Instrument 51-102 - Continuous Disclosure Obligations) between the Company and the Former Auditor. In accordance with National Instrument 51-102, the Notice of Change of Auditor, together with the required letters from the Former Auditor and the Successor Auditor, have been reviewed by the Company's audit committee and board of directors and have been filed on the Company’s SEDAR+ profile at www.sedarplus.ca. About XORTX Therapeutics Inc. XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our lead, XRx-008 program for ADPKD; 2) our XRx-026 program for the treatment of allopurinol intolerant gout; and 3) our secondary program in XRx-101 for acute kidney and other acute organ injury associated with Coronavirus / COVID-19 infection. In addition, XRx-225 is a pre-clinical stage program for Type 2 Diabetic Nephropathy. XORTX is working to advance its clinical development stage products that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit production of uric acid. At XORTX, we are dedicated to developing medications to improve the quality of life and health of kidney disease patients and individuals with gout. Additional information on XORTX is available at www.xortx.com. For more information, please contact: Allen Davidoff, CEO Nick Rigopulos, Director of Communicationsadavidoff@xortx.com or +1 403 455 7727nick@alpineequityadv.com or +1 617 901 0785 Neither the TSX Venture Exchange nor Nasdaq has approved or disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

BAGSVAERD, Denmark I January 17, 2025 I Novo Nordisk today announced headline results from STEP UP, a phase 3b trial in the global STEP programme. STEP UP is a 72-week efficacy and safety trial investigating subcutaneous semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo, all administered once weekly. The trial included 1,407 randomised adults with obesity. All treatment arms were in conjunction with lifestyle intervention. The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 72 with semaglutide 7.2 mg versus placebo. When evaluating the effects of treatment if all people adhered to treatment 1 from a mean baseline body weight of 113 kg, people treated with semaglutide 7.2 mg achieved a superior weight loss of 20.7% after 72 weeks compared to a reduction of 17.5% with semaglutide 2.4 mg and 2.4% with placebo. In addition, 33.2% of those who received semaglutide 7.2 mg achieved a weight loss of 25% or more after 72 weeks, compared to 16.7% with semaglutide 2.4 mg and 0.0% with placebo. When applying the treatment policy estimand 2 , people treated with semaglutide 7.2 mg achieved a superior weight loss of 18.7% compared to a reduction of 15.6% with semaglutide 2.4 mg and 3.9% with placebo. In the trial, semaglutide 7.2 mg appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with the GLP-1 receptor agonist class. “We are very pleased to demonstrate 20.7% weight loss and to see that 33% of patients achieved more than 25% weight loss with semaglutide 7.2 mg, with a safety and tolerability profile comparable to semaglutide 2.4 mg,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “Results from STEP UP further strengthen the clinical profile of semaglutide for the treatment of obesity, in addition to the health benefits already established with Wegovy ® , including cardiovascular risk reduction as seen in SELECT”. The results from the second semaglutide 7.2 mg phase 3 trial, STEP UP T2D, in adults with type 2 diabetes and obesity are expected within the next few months. Detailed results from the STEP UP trial are expected to be presented at a scientific conference in 2025. About the STEP UP trials Novo Nordisk has initiated two trials investigating the efficacy of semaglutide 7.2mg, STEP UP and STEP UP T2D. The 72-week STEP UP trial was a randomised, double-blinded, parallel-group, placebo-controlled, superiority trial designed to evaluate the efficacy of semaglutide 7.2 mg with semaglutide 2.4 mg and placebo as an adjunct to lifestyle intervention. 1,407 adults with BMI ≥30 kg/m 2 and without diabetes were included in the trial. The primary objective was to demonstrate superiority of semaglutide 7.2 mg against placebo on weight loss. Key secondary endpoints included number of participants achieving 10%, 15%, 20% and 25% weight loss, respectively. The ongoing 72-week STEP UP T2D trial will investigate semaglutide 7.2 mg in 512 adults with obesity and type 2 diabetes, with the primary objective to demonstrate superiority of semaglutide 7.2 mg against placebo on weight loss. About Wegovy ® (semaglutide 2.4 mg) Semaglutide 2.4 mg is marketed under the brand name Wegovy ® . In the EU, Wegovy ® is indicated as an adjunct to a reduced calorie diet and increased physical activity for weight management in adults with a BMI of 30 kg/m2 or greater (obesity) or adults with a BMI of 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbid condition. In the EU, Wegovy ® is also indicated for paediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity) and body weight above 60 kg. The clinical section of the label also includes data showing the benefits of Wegovy ® in reducing the risk of MACE, improving HFpEF-related symptoms and physical function, as well as reducing pain related to knee osteoarthritis. In the US, Wegovy ® is indicated in combination with a reduced calorie diet and increased physical activity to reduce the risk of MACE in adults with established cardiovascular disease and either obesity or overweight, as well as to reduce excess body weight and maintain weight reduction long term in adults and paediatric patients aged 12 years and older with obesity and in adults with overweight in the presence of at least one weight-related comorbid condition. About Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 72,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com , Facebook , Instagram , X , LinkedIn and YouTube . 1 Based on the trial product estimand: treatment effect if all people adhered to treatment 2 Based on the treatment policy estimand: treatment effect regardless of treatment adherence SOURCE: Novo Nordisk

Sage Therapeutics has sued Biogen in Delaware court, one week after receiving a $469 million buyout offer from the larger neuroscience pharma company. The full lawsuit was sealed, and the court said the case was confidential after being contacted by Endpoints News . But a separate court filing from Sage states that it is “seeking preliminary injunctive relief to enforce a standstill agreement and a trial on a paper record on an expedited basis.” Biogen declined to comment on ongoing litigation. A spokesperson for Sage said that “any discussions between Biogen and Sage regarding an acquisition of Sage should be conducted in private.” The spokesperson added that the company is seeking a temporary restraining order “to preserve our rights and enforce the standstill provision previously agreed to with Biogen.” Sage is still evaluating the proposal from Biogen, and a decision has not yet been made. The two longtime partners are, for the moment, at odds. Biogen owns roughly 10% of Sage, but the offer is lower than the amount of cash and equivalents the biotech had as of the end of September. The saga started a week ago when Biogen CEO Chris Viehbacher wrote to Sage chief Barry Greene in a publicly disclosed letter outlining the proposal. Though Viehbacher praised Sage’s efforts, he said that Biogen having full control would “enable more streamlined operations and efficient commercial execution” of postpartum depression medication Zurzuvae. The two companies linked up in November 2020 to co-develop and commercialize the drug, then known by its generic name zuranolone. But Sage’s share price has fallen by about 90% in the last five years, as the company has been beset by clinical trial failures. The commercial opportunity for Zurvuvae is also less than hoped for, after the FDA rejected it as a major depression treatment at the same time the PPD indication was approved. Bloomberg Law first reported on the lawsuit. Alexis Kramer contributed reporting.