Nocturia

Multi-center clinical study designed to evaluate safety, tolerability and effectiveness of a novel biopolymer device. BEVERLY, Mass. & MELBOURNE, Australia--(BUSINESS WIRE)-- Glycologix, Inc. (“Glycologix”), a clinical-stage company focused on developing biopolymers for the protection and repair of soft tissues, today announced the treatment of the first patient in a pilot clinical study evaluating GLX-100 as a novel treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). The multi-center pilot trial is designed to assess the safety, tolerability and effectiveness of GLX-100 in participants with IC/BPS and is expected to enroll up to 40 women with results anticipated in 2024. IC/BPS is a urological disorder that often compromises the integrity of the inner bladder wall lining, resulting in intense pain and pressure in the bladder often accompanied by urinary frequency, urgency and nocturia. GLX-100 is a novel biopolymer, which has been designed to closely replicate the natural protective barrier layer and relieve the symptoms of IC/BPS. IC/BPS affects approximately 10 million people in the U.S., predominantly women.1,2 However, currently available treatment options often fail to manage the symptoms and no new treatments have been approved in the US since 1996. Commenting on the initiation of the clinical study, Professor Anna Rosamilia, Principal Investigator at Melbourne’s Monash University said, “Options for treating IC/BPS today are quite limited and this important trial provides an exciting opportunity to evaluate the potential of GLX-100 to improve the lives of patients in desperate need of new and better treatment options. We look forward to sharing the results from the study in 2024.” About Glycologix Glycologix, Inc. is an emerging company dedicated to development and commercialization of rationally designed biopolymers for the protection and repair of soft tissues. Glycologix technology can target significant unmet medical needs and major market opportunities. Glycologix’ lead program is focused on GLX-100 for the treatment of IC/BPS. For more information, visit . References Berry, SH. J Urol 2011; 186:540-4. Suskind, AM. J Urol 2013; 189(1):141-5. Forward Looking Statements This press release discusses investigational uses of a treatment in development and is not intended to convey conclusions about safety or effectiveness. There is no guarantee that the therapy listed in this release will successfully complete development or gain regulatory authorizations or approvals.

–Vibegron Met Both Co-Primary Endpoints Demonstrating Statistically Significant Reductions in Daily Micturition and Urgency Episodes, Compared to Placebo at Week 12– –Vibegron Met All Secondary Endpoints, Including a Reduction in Nocturia Episodes Versus Placebo at Week 12– –Open-label Extension Trial Showed Reductions in Daily Micturition and Urgency Episodes Were Maintained Up to 52 Weeks– –Vibegron Was Well-Tolerated and Demonstrated a Consistent Safety Pro No New Safety Signals Compared to Prior Overactive Bladder Studies– CAMBRIDGE, Mass. and BASEL, Switzerland, Sept. 11, 2023 /PRNewswire/ -- Sumitomo Pharma Co., Ltd. companies, Sumitomo Pharma America, Inc. (SMPA) and Sumitomo Pharma Switzerland (SMPS), announced today that the Phase 3 URO-901-3005 clinical study of vibegron (GEMTESA®), a beta-3 adrenergic receptor (β3) agonist, dosed once-daily (75 mg), which is being investigated in men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH), met its co-primary endpoints at Week 12 compared to placebo. The co-primary endpoints include both change from baseline in the average number of micturition (urination) episodes per day and change from baseline in the average number of urgency episodes (the sudden urge to urinate that is difficult to control) per day. URO-901-3005 was a Phase 3 multicenter, randomized, double-blind, parallel-group, fixed-dose study which evaluated the efficacy, safety, and tolerability of vibegron versus placebo over 24 weeks in 1,105 men with OAB symptoms receiving pharmacological therapy for BPH. In the primary efficacy analysis, once-daily vibegron met the co-primary endpoints at Week 12, demonstrating statistically significant reductions from baseline (least squares means) in daily micturitions (-2.04 [SE: 0.109]; p<0.0001) and in daily urgency episodes (-2.88 [SE: 0.164]; p<0.0001) compared to placebo (-1.30 [SE: 0.109] and -1.93 [SE: 0.164], respectively). In the study, patients receiving vibegron met all secondary endpoints at Week 12, including a statistically significant reduction in the key secondary endpoint of average number of nocturia episodes per night compared to placebo (-0.88 compared to -0.66; p=0.0015). Additionally, patients receiving vibegron showed statistically significant reductions from baseline compared to placebo in the average number of urge urinary incontinence episodes per day (-2.19 compared to -1.39; p=0.0034) and International Prostate Symptom Storage score (-3.0 compared to -2.1; p<0.0001), while a statistically significant increase was seen in the average volume voided per micturition (25.63 mL compared to 10.56 mL; p<0.0001). "Millions of men struggle with the burdensome symptoms of OAB which are further exacerbated by BPH, including frequent and urgent need to urinate, difficulty or delay in urinating, and waking up in the middle of the night to urinate. These symptoms can have a significant negative impact on patients' lives, including long-term sleep deprivation," said Armin Szegedi, M.D., Ph.D., Chief Medical Officer at SMPA. "These data from URO-901-3005 demonstrate the potential of vibegron and speaks to our commitment to addressing the unmet needs of those experiencing urologic conditions." "We are pleased to share the results of this study, which underscores the promise of one of our key marketed assets beyond its initial approved indication," said Myrtle Potter, President and Chief Executive Officer of SMPA. "With these positive data, we look forward to exploring the potential of vibegron as an option for men experiencing OAB symptoms and BPH." The safety and tolerability of vibegron was assessed throughout the study. Overall, vibegron was well-tolerated throughout the study and demonstrated a consistent safety pro no new safety signals compared to prior OAB studies. The most common adverse events occurring in at least 2% of the vibegron 75 mg group and at a rate higher than placebo were hypertension (9.0% and 8.3%, respectively), COVID-19 (4.0% and 3.1%, respectively), and urinary tract infection (2.5% and 2.2%, respectively). The frequency of serious adverse events was similar across treatment arms (4.3% in vibegron, 2.9% in placebo). "OAB is often misconstrued as a normal part of aging instead of a clinical condition," said Adele Gulfo, Chief Executive Officer of Biopharma Commercial Unit at SMPA. "Since its launch, vibegron has helped more than 200,000 patients and long-term care residents living with OAB. We are committed to continued innovation and bringing novel treatment options to those living with often underdiscussed urologic conditions." Patients who completed URO-901-3005 were eligible to continue onto URO-901-3006, an open-label, 28-week extension study evaluating the safety, tolerability, and efficacy of vibegron 75 mg in men with symptoms of OAB who are receiving pharmacological therapy for BPH. Results from the open-label extension study show reductions in the average number of micturitions per day and urgency episodes per day were maintained up to 52 weeks. Reductions in nocturia, urge urinary incontinence, International Prostate Symptom Storage score, and increase in average volume voided per micturition were also maintained up to 52 weeks. Overall, vibegron was well-tolerated throughout the study and demonstrated a consistent safety pro no new safety signals compared to prior studies. Results will be presented at future medical congresses. Use of GEMTESA in men with symptoms of OAB receiving pharmacological therapy for BPH is not approved and its safety and efficacy have not been evaluated by regulatory authorities. About GEMTESA (vibegron) Vibegron, a once-daily beta-3 adrenergic receptor (β3) agonist, is currently under investigation for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia in the United States (U.S.). In the U.S., GEMTESA (vibegron) has been indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults since April 2021. GEMTESA works by selectively targeting β3 adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase capacity. In China, vibegron is currently under investigation in a Phase 3 clinical study for the treatment of OAB. About Overactive Bladder Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), and frequent urination (usually eight or more times in 24 hours).1 About 33 million U.S. adults experience the bothersome symptoms of OAB.2 About Benign Prostatic Hyperplasia Benign prostatic hyperplasia (BPH) is a condition in men in which the prostate gland is enlarged. About 60% of men with BPH are treated for lower urinary tract symptoms (LUTS).3,4 LUTS can be divided into storage, voiding, and postmicturition symptoms.5 Over half of men with BPH report storage symptoms and about a quarter report voiding symptoms.4 This suggests that many men with a diagnosis of BPH may have overactive bladder.4 Many men who are treated for symptoms are assumed to have an obstruction in the bladder caused by an enlarged prostate.3,4 About half of all men between ages 51 and 60 have BPH and up to 90% of men over age 80 are living with the condition.6 INDICATIONS AND USAGE GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of the product. WARNINGS AND PRECAUTIONS Urinary Retention Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction and patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention. ADVERSE REACTIONS Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. Please see full Prescribing Information. About Sumitomo Pharma America, Inc. Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. The company's diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. SMPA leverages proprietary in-house advanced analytics and computational technology platforms to accelerate discovery, research, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma Co., Ltd., company. For more information on SMPA, visit our website or follow us on LinkedIn. About Sumitomo Pharma Co., Ltd. Sumitomo Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries with about 6,000 employees worldwide. Sumitomo Pharma Group defines its Mission as "To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide." Additional information about Sumitomo Pharma is available through its corporate website at . The Sumitomo Pharma icon is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. GEMTESA is a trademark of Urovant Sciences GmbH © 2023 Sumitomo Pharma America, Inc. All rights reserved. For a copy of this release, visit Sumitomo Pharma America's website at . References Overactive bladder – symptoms and causes. Mayo Clinic. 2022. Accessed August 25, 2023. Gomelsky A. Update on the management of overactive bladder: patient considerations and adherence. Journal of Urology. Open Access J Urol. 2011; 3: 7–17. Published online 2010 Dec 30. doi: 10.2147/OAJU.S7233 Burnett AL, Walker DR, Feng Q, Johnston KM, Lozano-Ortega G, Nimke D, Hairston JC. Undertreatment of overactive bladder among men with lower urinary tract symptoms in the United States: A retrospective observational study. Neurourol Urodyn. 2020 Jun;39(5):1378-1386. doi: 10.1002/nau.24348. Epub 2020 May 8. PMID: 32383533; PMCID: PMC7384148. Anger, JT, Goldman, HB, Luo, X, et al. Patterns of medical management of overactive bladder (OAB) and benign prostatic hyperplasia (BPH) in the United States. Neurourology and Urodynamics. 2018; 37: 213–222. Lepor H. Pathophysiology of lower urinary tract symptoms in the aging male population. Rev Urol. 2005;7 Suppl 7(Suppl 7):S3-S11. PMID: 16986059; PMCID: PMC1477625. Benign Prostatic Hyperplasia (BPH). Urology Care Foundation. 2021. Accessed August 25, 2023. (bph)

Multiple Sleep Specialists in the Same Office Nearby DALLAS and FORT WORTH, Texas, July 19, 2023 /PRNewswire/ -- According to America's Health Rankings with the United Health Foundation, about 33.2 percent of Texans regularly get insufficient sleep in a 24-hour period. This means that up to a third of Texan residents may face issues like insomnia, loud snoring, sleep apnea, and nocturia every night. Without treatment, these sleep issues can lead to many health problems, including high blood pressure, mental illnesses, and extreme fatigue, as well as drowsy driving and auto accidents. Continue Reading Star Sleep & Wellness Logo To facilitate diagnosis and treatment of these conditions, Star Sleep & Wellness has recently opened five locations throughout Dallas Metroplex, namely in Dallas, Denton, Frisco, Irving, and Plano. Unlike other sleep centers, Star Sleep & Wellness practices provide truly comprehensive services. Instead of sending patients from specialist to specialist, Star Sleep & Wellness brings all the experts to the patient to provide the appropriate treatment(s). Traditionally, people who suffer from sleep apnea and other disorders must first undergo a sleep study with a sleep physician. After being diagnosed, they usually need to visit various practices to figure out the cause and identify therapies that will best help them achieve deeper, more restful sleep. On the staff at Star Sleep & Wellness, CEO Dr. Kent Smith has assembled a "dream team" of sleep specialists at of the top of their fields, including sleep physicians, a licensed psychologist, nurse practitioners (NPs), physician assistant (PA), and sleep dentists. As a result, Dr. Smith says, "Star Sleep & Wellness is able to not only diagnose sleep disorders through testing but also provide care from start to finish in one office with therapies that range from oral appliances to psychiatric treatment, from CPAPs to weight loss support." Dr. Smith also says, "With all our expertise and locations, help with sleep issues is more accessible for everyone." Through this team approach, Star Sleep & Wellness can help people with sleep conditions consistently get a good night's rest, reducing fatigue and many other negative symptoms. If you struggle to get sufficient quality sleep, you are invited to contact one of the five locations of Star Sleep & Wellness for an appointment. More Information: Website for each location: Addresses of each location: Star Sleep & Wellness of Dallas 5477 Glen Lakes Drive Suite 100 Dallas, TX 75231 Star Sleep & Wellness of Denton 2245 Brinker Rd #100 Denton, TX 76210 Star Sleep & Wellness of Frisco 3800 Gaylord Pkwy, St. 1190 Frisco, TX 75034 Star Sleep & Wellness of Irving 290 E John W Carpenter Fwy Suite 2700, Irving, TX 75062 Star Sleep & Wellness of Plano 1700 Coit Rd. Suite 110 Plano, TX 75075 SOURCE Star Sleep & Wellness