Latest news with #chronicKidneyDisease
Medscape
6 days ago
- General
- Medscape
Poor Air Quality Linked to Higher Risk for Mortality in COPD
Individuals with chronic obstructive pulmonary disease (COPD) were vulnerable to even small increases in fine particulate matter < 2.5 μm in diameter (PM2.5), with significantly higher risk among those with comorbidities such as lung cancer, coronary arterial disease, or chronic kidney disease. METHODOLOGY: Researchers conducted a retrospective cohort analysis to assess the association between long-term exposure to PM2.5 and all-cause mortality in veterans with COPD. They included 1,124,973 veterans (mean age, 68 years; 95.60% men) diagnosed with COPD between 2016 and 2019 who were enrolled in the Veterans Health Administration. They obtained ambient PM2.5 concentrations from annual air pollution models from 2000 to 2016, available at NASA's Socioeconomic Data and Applications Center; the average 5-year PM2.5 exposure for the cohort was 8.18 µg/m 3 . . The odds of all-cause mortality associated with 5-year average PM2.5 exposure were estimated, and comorbidities associated with mortality were identified. TAKEAWAY: Each 1 μg/m 3 increase in long-term PM2.5 exposure was associated with a 3.8% increase in the odds of mortality (adjusted odds ratio [aOR], 1.038; 95% CI, 1.035-1.040) among patients with COPD. increase in long-term PM2.5 exposure was associated with a 3.8% increase in the odds of mortality (adjusted odds ratio [aOR], 1.038; 95% CI, 1.035-1.040) among patients with COPD. Individuals with comorbidities such as lung cancer (aOR, 1.051; 95% CI, 1.035-1.068), coronary arterial disease (aOR, 1.039; 95% CI, 1.033-1.044), and chronic kidney disease (aOR, 1.042; 95% CI, 1.034-1.049) showed higher susceptibility to PM2.5 exposure than those without comorbidities. Men, individuals living in the most disadvantaged neighborhoods, and those identifying as Asian had higher odds of mortality with increasing PM2.5 exposure. Decreases in PM2.5 concentrations were associated with lower odds of all-cause mortality at all exposure levels for patients with COPD and those with additional comorbidities. IN PRACTICE: 'Our findings suggest that even small decreases in PM2.5 NAAQS [National Ambient Air Quality Standards] will benefit the millions of Americans living with COPD,' the authors wrote. SOURCE: This study was led by Camille Robichaux, MD, University of Minnesota, Minneapolis. It was published online on May 2, 2025, in Annals of the American Thoracic Society . LIMITATIONS: The veteran population studied was older, consisted solely of men, and had a higher prevalence of smoking and comorbidities, potentially limiting generalizability. Additionally, the use of modeled data for air pollution exposure, rather than direct measurements, may not have provided an accurate representation of individual exposure levels. DISCLOSURES: This study was supported by grants from the National Institutes of Health's National Heart, Lung, and Blood Institute; the National Center for Advancing Translational Sciences; and others. Resources and facilities were provided by the Minneapolis VA Health Care System. The authors declared having no conflicts of interest.
NHK
27-05-2025
- Health
- NHK
Things You Should Do To Prevent CKD - Medical Frontiers
A large-scale study in Japan has shown that improving one's diet and lifestyle can slow the progression of chronic kidney disease. Clinical trials in regenerative medicine are also underway. Dialysis is usually done three times a week, with each session lasting four hours Small changes to diet and lifestyle can make a big difference Diabetes medication is effective for CKD Administering stem cells to mice reduced kidney inflammation
Globe and Mail
14-05-2025
- Business
- Globe and Mail
Unicycive Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Update
- Oxylanthanum carbonate (OLC) New Drug Application (NDA) for hyperphosphatemia in chronic kidney disease patients on dialysis under review by FDA with PDUFA target action date of June 28, 2025; ongoing commercial planning in preparation for anticipated commercial launch in late 2025 - New data from patient surveys and patient-reported outcomes studies highlight adherence challenges for patients with hyperphosphatemia on dialysis and emphasize the market potential of OLC LOS ALTOS, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended March 31, 2025, and provided a business update. 'We are making incredible strides as we prepare for the potential FDA approval of oxylanthanum carbonate (OLC) so we can bring this treatment to people with chronic kidney disease (CKD) on dialysis as efficiently as possible,' said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. 'The need for our differentiated treatment, which offers high potency and a significantly reduced pill burden for people struggling to control hyperphosphatemia, has been further validated by new patient survey findings and patient-reported outcomes data. We remain dedicated to bolstering our commercial infrastructure as we strive to deliver a much-needed solution to patients and healthcare providers.' Key Highlights & Upcoming Milestones The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025, for OLC. Unicycive continues to prepare for the potential launch of OLC by building key functions, engaging directly with prescribers and other stakeholders, and supporting market access. Expanded awareness of OLC and its potential to address significant needs for CKD patients by publishing data and presentations at medical meetings. Recently, findings were presented at the National Kidney Foundation (NKF) Spring Clinical Meetings and the 2025 American Nephrology Nurses Association (ANNA) National Symposium from a patient survey conducted in partnership with the NKF. The survey included a total of 200 dialysis patients who identified excessive pill numbers, large pill sizes, and forgetfulness as the primary barriers to phosphate binder adherence. Patients also expressed a strong preference for medication regimens with fewer and smaller pills. New patient-reported outcomes data from the pivotal Phase 2 study of OLC were presented at the 2025 American Dialysis Conference (ADC) and the NKF Spring Clinical Meeting, which demonstrated that patients preferred OLC in comparison to their pre-trial phosphate binder medications and significantly enhanced patient satisfaction. Financial Results for the Quarter Ended March 31, 2025 Research and Development (R&D) expenses were $2.2 million for the three months ended March 31, 2025, compared to $6.8 million for the three months ended March 31, 2024. The decrease in research and development expenses was primarily due to decreased drug development costs. General and Administrative (G&A) expenses were $5.8 million for the three months ended March 31, 2025, compared to $2.4 million for the three months ended March 31, 2024. The increase was primarily due to increased consulting and professional services related to our commercial launch preparation. In addition to the above launch expenses, we continue to focus on the manufacturing of commercial supplies, as reflected in prepaid expenses and other current assets on our balance sheet which increased from $4.8 million as of December 31, 2024 to $7.6 million as of March 31, 2025. Other income was $8.6 million for the three months ended March 31, 2025, compared to an expense of $11.8 million for the three months ended March 31, 2024, primarily due to a decrease in the fair value of our warrant liability. Net income attributable to common stockholders for the three months ended March 31, 2025, was $0.5 million, compared to a net loss attributable to common stockholders of $21.2 million for the three months ended March 31, 2024. The net income for the three-month period ended March 31, 2025, was primarily due to a decrease in the fair value of our warrant liability. As of March 31, 2025, cash and cash equivalents totaled $19.8 million. About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive's second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information about Unicycive, visit and follow us on LinkedIn and X. Forward-looking statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled 'Risk Factors' in Unicycive's Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Contacts: Kevin Gardner LifeSci Advisors kgardner@ Media Contact: Rachel Visi Real Chemistry redery@ SOURCE: Unicycive Therapeutics, Inc. Unicycive Therapeutics, Inc. Balance Sheets (in thousands, except for share and per share amounts) As of As of December 31, March 31, 2024 2025 (Unaudited) Assets Current assets: Cash $ 26,142 $ 19,769 Prepaid expenses and other current assets 4,806 7,577 Total current assets 30,948 27,346 Right of use asset, net 645 518 Property, plant and equipment, net 75 83 Total assets $ 31,668 $ 27,947 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 1,058 $ 1,397 Accrued liabilities 3,562 4,143 Warrant liability 18,936 10,588 Operating lease liability - current 564 548 Total current liabilities 24,120 16,676 Operating lease liability - long term 117 - Total liabilities 24,237 16,676 Commitments and contingencies Stockholders' equity: Series A-2 Prime preferred stock, $0.001 par value per share - 21,338.01 Series A-2 Prime shares authorized at December 31, 2024 and March 31, 2025; 6,150.21 and 5,464.21 Series A-2 Prime shares issued and outstanding at December 31, 2024 and March 31, 2025, respectively - - Series B-2 preferred stock, $0.001 par value per share - 7,882 Series B-2 shares authorized at December 31, 2024 and March 31, 2025; 3,000 Series B-2 shares issued and outstanding at December 31, 2024 and March 31, 2025 - - Preferred stock: $0.001 par value per share - 9,846,891 shares authorized at December 31, 2024 and March 31, 2025; zero shares issued and outstanding at December 31, 2024 and March 31, 2025 - - Common stock, $0.001 par value per share - 400,000,000 shares authorized at December 31, 2024 and March 31, 2025; 113,842,364 and 119,749,743 shares issued and outstanding at December 31, 2024 and March 31, 2025, respectively 114 120 Additional paid-in capital 108,587 111,851 Accumulated deficit (101,270 ) (100,700 ) Unicycive Therapeutics, Inc. Statements of Operations (in thousands, except for share and per share amounts) (Unaudited) Three Months Ended March 31, 2024 2025 Operating expenses: Research and development $ 6,813 $ 2,171 General and administrative 2,391 5,818 Total operating expenses 9,204 7,989 Loss from operations (9,204) (7,989) Other income (expenses): Interest income 69 226 Interest expense (20) (15) Change in fair value of warrant liability (11,808) 8,348 Total other income (expenses) (11,759) 8,559 Net (loss) income (20,963) 570 Net (loss) income attributable to common stockholders, basic (21,171) 510 Net loss attributable to common stockholders, diluted (21,171) (6,214) Net (loss) income per share: Basic $ (0.61) $ - Diluted $ (0.61) $ (0.05) Weighted-average shares outstanding: Basic 34,912,692 116,818,811 Diluted 34,912,692 123,834,773
Medscape
12-05-2025
- Health
- Medscape
Multiple Comorbidities Can Have Big Impact on SSc Outcomes
In a cohort of 2000 patients with systemic sclerosis (SSc), 20% were found to have multimorbidity, primarily driven by cardiovascular disease and other important cardiovascular risk factors. The presence of multimorbidity was linked to reduced survival rates and impaired physical function. METHODOLOGY: Researchers aimed to determine the frequency and prognostic impact of multimorbidity in 2000 patients with SSc (median age at SSc onset , 47.4 years; 85.4% women) from the Australian Scleroderma Cohort Study. Charlson Comorbidity Index (CCI) scores were calculated at each visit for all participants, with multimorbidity defined as having a CCI score of ≥ 4. Health Assessment Questionnaire Disability Index scores were collected every year during study visits, whereas data on demographics, disease, and medication use were collected at each visit. The median duration of SSc at recruitment was 7.1 years, and the median follow-up duration was 4.2 years. TAKEAWAY: During the follow-up period, multimorbidity was observed in 20.1% of participants at a median of 12 years after the onset of SSc; the key comorbidities were hypertension (80.5%), dyslipidemia (67.2%), obstructive lung disease (50.4%), malignancy (48.9%), and ischemic heart disease (40.1%). The presence of multimorbidity increased the risk for death by 57% (hazard ratio [HR], 1.57; P < .01), with chronic kidney disease showing the strongest association with mortality (HR, 2.41; P < .01), followed by left ventricular dysfunction (HR, 1.76; P < .01). < .01), with chronic kidney disease showing the strongest association with mortality (HR, 2.41; < .01), followed by left ventricular dysfunction (HR, 1.76; < .01). Having multimorbidity was also associated with poorer physical function ( P < .01), with peripheral vascular disease having the largest impact on physical function, followed by left ventricular dysfunction. IN PRACTICE: 'These data suggest a role for aggressive management of comorbid cardiac and renal disease to potentially improve outcomes in SSc,' the authors wrote. SOURCE: This study was led by Jessica L. Fairley, MBBS, The University of Melbourne and St Vincent's Hospital Melbourne, both in Melbourne, Australia. It was published online on April 21, 2025, in ACR Open Rheumatology . LIMITATIONS: The CCI was modified for application to the database as not all variables were available for analysis, including depression, cellulitis, liver disease, peptic ulcer disease, hemiplegia, HIV/AIDS, and dementia. This likely resulted in underestimating the frequency of multimorbidity in the cohort. Additionally, the Australian Scleroderma Cohort Study exhibits a degree of survivor bias, where more severely ill individuals may not survive to recruitment. DISCLOSURES: The Australian Scleroderma Cohort Study was supported by Janssen, Boehringer Ingelheim, Scleroderma Australia, and other sources. Some authors reported receiving grants, payments, honoraria, consulting fees, and travel support from, and having other ties with various pharmaceutical companies including the funding agencies.
