Urinary Incontinence, Stress

IRVINE, Calif.--( BUSINESS WIRE )--Axonics, Inc. (Nasdaq: AXNX) today announced that the jury has returned a unanimous verdict in the patent infringement lawsuit brought by Medtronic against Axonics in U.S. District Court for the Central District of California. The jury found that Axonics does not infringe any of the three patents-in-suit. “A jury of our peers recognized that Axonics’ proprietary tined lead design and temperature sensor technology is differentiated from our competitor’s intellectual property,” said Raymond W. Cohen, chief executive officer. “As we have said since this case was first filed in late 2019, our view is that Medtronic’s lawsuit was initiated to stifle competition, limit patient and physician choice, and protect the incumbent’s monopoly in sacral neuromodulation. We are very pleased with the jury’s finding and continue to remain focused on fulfilling our mission of positively impacting the lives of adults with bladder and bowel dysfunction.” About Axonics Axonics is a global medical technology company that is developing and commercializing novel products for adults with bladder and bowel dysfunction. Axonics ranked No. 2 on the 2023 Financial Times ranking of the fastest growing companies in the Americas after being ranked No. 1 in 2022 . Axonics ® sacral neuromodulation systems provide adults with overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, the company’s best-in-class urethral bulking hydrogel, Bulkamid ® , provides safe and durable symptom relief to women with stress urinary incontinence. In the U.S., moderate to severe urinary and bowel incontinence affects tens of millions of adults. For more information, visit www.axonics.com . Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words like “may,” “will,” “likely,” “should,” “expect,” “anticipate,” “future,” “plan,” “believe,” “intend,” “goal,” “seek,” “endeavor,” “estimate,” “project,” “continue,” and variations of such words and similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, assumptions, and uncertainties, including, but not limited to, risks related to: Axonics’ ability to consummate the transactions contemplated by the Agreement and Plan of Merger, dated January 8, 2024 (the “Merger Agreement”), by and among Axonics, Boston Scientific Corporation (“Boston Scientific”), and Sadie Merger Sub, Inc., a wholly owned subsidiary of Boston Scientific (“Merger Sub”), providing for the merger of Merger Sub with and into Axonics with Axonics continuing as the surviving company and a wholly owned subsidiary of Boston Scientific (the “Merger”), in a timely manner or at all; the risk that the Merger Agreement may be terminated in circumstances requiring the payment by Axonics of a termination fee; the satisfaction (or waiver) of the conditions to the closing of the Merger; potential delays in consummating the Merger; the occurrence of any event, change or other circumstance or condition that could give rise to termination of the Merger Agreement; Axonics’ ability to timely and successfully realize the anticipated benefits of the Merger; the ability to successfully integrate the businesses of Axonics and Boston Scientific; the effect of the announcement or pendency of the Merger on Axonics’ current plans, business relationships, operating results and business generally; the effect of limitations placed on Axonics’ business under the Merger Agreement; significant transaction costs and unknown liabilities; litigation or regulatory actions related to the Merger Agreement or Merger; FDA or other U.S. or foreign regulatory or legal actions or changes affecting Axonics or Axonics’ industry; the results of any ongoing or future legal proceedings, including the litigation with Medtronic, Inc., Medtronic Puerto Rico Operations Co., Medtronic Logistics LLC and Medtronic USA, Inc. (the “Medtronic Litigation”); any termination or loss of intellectual property rights, including as a result of the Medtronic Litigation; introductions and announcements of new technologies by Axonics, any commercialization partners or Axonics’ competitors, and the timing of these introductions and announcements; changes in macroeconomic and market conditions and volatility, including the risk of recession, inflation, supply chain constraints or disruptions and rising interest rates; and economic and market conditions in general and in the medical technology industry specifically, including the size and growth, if any, of Axonics’ markets, and risks related to other factors described under “Risk Factors” in other reports and statements filed with the U.S. Securities and Exchange Commission (“SEC”), including Axonics’ most recent Annual Report on Form 10-K, which is available on the investor relations section of Axonics’ website at www.axonics.com and on the SEC’s website at www.sec.gov . Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by these forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. The forward-looking statements included in this press release are made only as of the date of this press release, and except as otherwise required by federal securities law, Axonics does not assume any obligation nor does it intend to publicly update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

MANCHESTER, England & MOUNTAIN VIEW, Calif.--( BUSINESS WIRE )--Axalbion, a clinical-stage biopharmaceutical company focused on developing novel medicines to treat cough, announced that the first patient has been dosed in the second part of a Phase 2 proof-of-concept, randomized, placebo-controlled clinical study in chronic cough with AX-8, its lead compound. AX-8 is a potent and selective oral agonist of the transient receptor potential melastatin 8 (TRPM8) ion channel. The company has raised additional financing from existing and new investors to support the trial execution and Phase 3 planning. “We are pleased to announce that Axalbion has launched the second part of its Phase 2 clinical trial with AX-8 in chronic cough, a disease with significant unmet needs,” said Michael Kitt, MD, chief executive officer of Axalbion. “In the first part of this study, AX-8 showed promising results with a robust and sustained reduction in cough frequency, particularly in patients experiencing the greatest throat discomfort, a distressing symptom observed in most chronic cough patients.” Data were presented in an oral session at the American Thoracic Society (ATS) 2023 International Conference. Based on the initial positive findings, the company initiated Part 2 of the study of AX-8 in patients with chronic cough with moderate-to-severe throat discomfort (i.e., those with a throat discomfort visual analog scale score ≥50mm out of 100mm), who are the most likely to benefit from treatment with AX-8. The Phase 2 trial is a randomized, double-blind, placebo-controlled, crossover study evaluating the efficacy and safety of AX-8 in approximately 50 patients with refractory or unexplained chronic cough (RCC/UCC). Patients will receive 40 mg of the drug or matching placebo thrice daily (as opposed to twice daily in Part 1) approximately four hours apart for two weeks, followed by a seven-day washout period, before crossing over to the opposite treatment for two weeks. AX-8 is formulated as an orally disintegrating tablet placed on the tongue. Cough frequency will be assessed with an objective cough recording device. The primary efficacy endpoint will be the placebo-adjusted change in cough frequency compared to baseline. The study will take place at multiple centers in the U.K. and is expected to be completed by the second half of 2025. For more information, please visit clinicaltrials.gov: NCT04866563 . About TRPM8 and AX-8 TRPM8 is expressed in many of the sensory fibers innervating the upper airways. Axalbion believes that activating TRPM8-expressing fibers with AX-8, a potent TRPM8 agonist, will normalize the upper airway sensitivity in chronic cough patients, decreasing coughing and irritation of the throat. David Julius and Ardem Patapoutian were awarded the 2021 Nobel Prize in Physiology or Medicine for their discoveries of thermal and mechanical transducers, including the discovery of TRPM8. Since its cloning in 2002, extensive research has identified TRPM8 as a potential target to relieve symptoms or cure several diseases. Animal models have shown that activation of TRPM8-expressing fibers in the skin inhibits sensory hypersensitivity in peripheral neuropathy and inflammation, as well as itching. About Chronic Cough Chronic cough is defined as a cough lasting for more than eight weeks, often occurring in bouts. More than 80% of patients in tertiary cough clinics have throat irritation which triggers cough bouts, defining a population with oropharyngeal hypersensitivity potentially responding to a topical locally acting drug such as AX-8. After potential triggers such as gastro-intestinal reflux disease (GERD) and asthma have been excluded or treated, cough still remains a significant and common problem for many patients. Chronic cough has a substantial impact on quality of life, for example, around half of female patients having urinary stress incontinence. There are no approved drugs for the treatment of chronic cough in the U.S., making it a significant unmet need affecting approximately 26 million people in the U.S. alone, with approximately three million having RCC/UCC lasting for more than a year and approximately six million having RCC/UCC lasting more than eight weeks and less than one year. About Axalbion Axalbion is a privately held, clinical-stage biotechnology company developing novel medicines for the treatment of chronic cough. The company, founded in December 2016, is based in Manchester, United Kingdom, a region known for its centers of excellence in respiratory research. For further information, please visit www.axalbion.com .

TUESDAY, July 30, 2024 -- Once-daily TAS-303 is superior to placebo for treatment of stress urinary incontinence (SUI) in women, according to a study published in the August issue of The Journal of Urology . Satoru Takahashi, M.D., Ph.D., from Nihon University School of Medicine in Tokyo, and colleagues conducted a double-blind phase 2 study involving women with SUI symptoms who were randomly allocated to receive once-daily oral administration of TAS-303 18 mg or placebo for 12 weeks (116 and 115 patients, respectively). The percent change from baseline to week 12 in mean SUI episode frequency per 24 hours (SUIEF) was examined in the per-protocol set as the primary end point. The researchers found that TAS-303 had superior efficacy to placebo at week 12, with a least squares mean percentage change in mean SUIEF of −57.7 versus −46.9 percent, respectively, in the per-protocol set. In the full analysis set, some evidence of improved incontinence episode frequency, incontinence amount, and health-related quality of life was seen at week 12 for TAS-303 versus placebo. In patients with two or more SUI episodes daily at baseline, the between-group difference in SUIEF improvement was more clearly confirmed. All adverse events with TAS-303 were mild or moderate. "Further validation studies in larger more diverse populations are needed to confirm the efficacy and safety of TAS-303 in women with SUI," the authors write. Several authors disclosed ties to pharmaceutical companies, including Taiho Pharmaceuticals, which is developing TAS-303 and funded the study. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.