Ramipril

WILMINGTON, N.C., May 14, 2024 /PRNewswire/ -- CardioPharma Inc. (the "Company"), a specialty pharmaceutical company focused on drug development for cardiovascular diseases, announced that on August 29, 2023, the United States Patent and Trademark Office ("USPTO") issued US Patent 11,737,988 B2 entitled "Anti-Hypertensive and Cholesterol-Lowering Fixed-Dose Combination and Method of Manufacture." Additional patents covering the subject matter of the '988 Patent have been granted in South Africa in 2022 and Australia, Armenia, Belarus, and the Russian Federation in 2024. Three further patents have been accepted in Canada, New Zealand, and Israel and will issue in the near future. In addition to the foregoing, CardioPharma is pursuing additional patents in major markets throughout the world, all of which together will bolster CardioPharma's global presence for the products covered by the patent grants. The 20-year term for all of the patents runs through April 17, 2039. CardioPharma Pipeline CardioPharma's pipeline products contain some of the world's most consumed, individually dispensed medications for the prevention and treatment of cardiovascular disease. The lead product, CardiaPill® is a unique formulation combining a cholesterol modifying agent ("statin"), an Angiotensin-converting-enzyme inhibitor (ACE Inhibitor) and anti-platelet agent. Statins moderate cholesterol levels and include products such as Lipitor®, Zocor®, Pravachol®; and Crestor®. ACE inhibitors reduce blood pressure and include products such as Altace®, Lotensin®, Capoten® and Accupril®. Pipeline products also include combinations using Angiotensin II Receptor Blockers (ARBs) as well as different statins and other anti-platelet agents. Simplicity of dosing, improved adherence and significant cost benefits for patients, providers and payors around the world are among the many compelling and well-documented benefits that make these inexpensive products so anticipated. About CardioPharma CardioPharma (), Inc. is a specialty pharmaceutical company focused on patent-protected combinatorial cardiovascular medications. CardioPharma's goal is to create drugs that make it easier and more cost-effective for doctors and their patients to reduce the morbidity and mortality of the world's number one killer – cardiovascular disease. The products are unique to the global pharmaceutical industry – highly cost-effective with proven efficacy; providing both patient and provider convenience; promoting adherence, while delivering superior clinical outcomes and economic benefits to all stakeholders. For more information, visit . Forward looking statements The information in this press release contains forward-looking statements including the prospective development, commercialization and regulatory approval in the U.S. and international markets. Words such as "expects," "plans," "believe," "may," "will," "anticipated," "intended" and variations of these words or similar expressions are intended to identify forward-looking statements. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors including the Company's ability to raise sufficient funds to bring new products to the global market. Contact: [email protected] SOURCE CardioPharma, Inc.

STOCKHOLM, Nov. 6, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas"), today announced data presentations highlighting additional analyses from the Phase 3 NefIgArd study with Nefecon in adults with primary IgA nephropathy (IgAN), as well as pre-clinical data on the treatment of Alport syndrome with setanaxib, a novel NOX inhibitor, presented at the American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA on November 1-5, 2023. "The additional analyses of data from the NeflgArd Phase 3 trial that we and our scientific collaborators presented at ASN Kidney Week showcased our commitment to advancing the science in understanding IgA nephropathy and to shaping a better future for patients with rare diseases," said Richard Philipson, Chief Medical Officer at Calliditas. Oral Presentation Analyses NefIgArd Phase 3 Trial full analysis The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN. The 2-year study period consisted of nine months of treatment with Nefecon (16 mg/day) or placebo, followed by a 15-month follow-up period off the study drug. The full analysis of the 364 patients randomized 1:1 to Nefecon or placebo showed: A statistically significantly smaller proportion of Nefecon-treated patients saw a 30% eGFR reduction compared to placebo-treated patients A delayed progression to a confirmed 30% eGFR reduction was observed in the Nefecon arm compared to the placebo arm Use of rescue medication did not alter the response to Nefecon vs placebo according to a pre-defined analysis Late-Breaking Poster Presentation Analyses NefIgArd Phase 3 trial population sub-analysis The 2-year NefIgArd trial included 62 patients with IgAN from mainland China (n=32 in Nefecon arm, n=30 in the placebo arm), with similar baseline characteristics as the global study population. In these patients, Nefecon treatment for 9 months resulted in: Lower time-weighted average change in eGFR from baseline in the Nefecon arm 66% less deterioration in renal function over the 2-year study period in the Nefecon arm, as well as reduced 2-year eGFR total slope 31% greater mean reduction in urine: protein creatinine ratio at 9 months in patients treated with Nefecon vs placebo, which was sustained at 2 years A higher proportion of Nefecon-treated patients did not display microhematuria during the observational follow-up period compared to patients who received placebo Poster Presentations Analyses Additional analyses were conducted from Part A of the Phase 3 NefIgArd trial(n=160) Serum samples collected from patients enrolled in Part A of the NefIgArd study were analyzed for functional protein interaction and showed that Nefecon modulates serum biomarkers associated with proteins known to play a role in the intestinal immune network for IgA production and control of B cell activation. These data further support a disease-modifying effect of Nefecon at the site of IgA synthesis and reinforce the link between the ileal gut-associated lymphoid tissue (GALT) and the kidneys. Levels of circulating anti-gliadin IgA and anti-casein IgA were reduced in IgAN patients treated with Nefecon vs placebo in Part A of the NefIgArd study at the 3-, 6- and 9-month mark after randomization. Levels of secretory IgA and fatty acid-binding protein, a gut permeability marker, were unchanged at these same time points. Reduction in IgA antibodies directed at dietary antigens supports a local disease-modifying effect for Nefecon via targeted action in the ileal GALT rather than modulation of gut permeability and antigen exclusion. Levels of three soluble biomarkers known for modulating B cell maturation, CD23, CD27, and CD30, were reduced in response to Nefecon 16 mg/day at the 3-, 6-, and 9-month post-randomization mark when compared to placebo responses. The degree of reduction in soluble CD23, CD27, and CD30 correlated with the magnitude of B-cell activating factor (BAFF) reduction at the same three study timepoints. Reduction in CD30 levels also correlated with the magnitude of IgA/IgG immune complex reduction at the 6- and 9-month timepoints. Together, these biomarker data add to the body of evidence supporting a disease-modification effect for Nefecon, including modulation of immune complex formation. Additional analysis from the full Phase 3 NefIgArd trial Modeling analyses leveraging the two-year eGFR total slope from 352 patients enrolled in the Phase 3 trial were applied to the records of 192 real-world IgAN patients to evaluate the long-term clinical potential of Nefecon. Using published linear regression analysis, Nefecon was predicted to substantially delay progression to renal failure, with a modeled 62 % risk reduction vs placebo and a median delay to progression of 12.8 years. Setanaxib The potential of setanaxib, a novel dual NOX inhibitor to modulate renal function and fibrosis was evaluated in a mouse model of Alport syndrome, a rare genetic disease characterized by fibrosis and progressive kidney damage. Setanaxib was evaluated alone or in combination with standard of care ramipril, an ACE inhibitor. Combined daily oral administration of setanaxib 60mg/kg and ramipril 10mg/kg resulted in a statistically significant reduction of urine albumin and albumin/creatinine ratio compared to vehicle alone after a 2-week and 4-week treatment duration. Histological analysis showed that this combination treatment decreased fibrosis and glomerular sclerosis. In silico and proteomics analyses demonstrated a reduction in both glomerular basement membrane proteins and collagen proteins in mice treated with both setanaxib and ramipril All presentations are available on the Presentations and Publications page on the Calliditas' corporate website. CONTACT: For further information, please contact: Åsa Hillsten, Head of Investor Relations & Sustanaibility, Calliditas Tel.: +46 76 403 35 43, email: [email protected] The information was sent for publication, through the agency of the contact persons set out above, on November 6, 2023 at 20:30 p.m. CET. The following files are available for download: SOURCE Calliditas Therapeutics