Latest news with #clinicalTrial
South China Morning Post
10-07-2025
- Health
- South China Morning Post
HKU launches clinical trial in Hong Kong to treat chronic hepatitis B patients
The University of Hong Kong (HKU) has launched a clinical trial for a gene-related therapy aimed at treating chronic hepatitis B infection, giving patients hope for a cure in the future. Professor Yuen Man-fung, chief of the division of gastroenterology and hepatology at HKU's medical faculty, said on Thursday that existing medication for hepatitis B patients could only suppress the virus and had to be taken for decades. He expected that the new treatment could enable patients to discontinue long-term medication. 'If we can suppress the virus and also eradicate the virus if possible, then the patients will not suffer or will have a minimal risk or lower risk of suffering from liver cancer development and cirrhosis or liver failure,' he said. 'And that obviously will bring hope … [to the] patients.' Chronic hepatitis B affects more than 300 million people worldwide and is a primary cause of liver cirrhosis, cancer and liver failure. Around 6.2 per cent of the population of Hong Kong is affected by the condition.
Yahoo
07-07-2025
- Business
- Yahoo
Corcept Therapeutics (CORT) Announces Pivotal Data from Phase 3 ROSELLA Trial
Corcept Therapeutics Incorporated (NASDAQ:CORT) is one of the 13 Best Pharma Stocks to Buy According to Wall Street Analysts. On June 2, Corcept Therapeutics Incorporated (NASDAQ:CORT) announced pivotal data from its Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer at the American Society of Clinical Oncology Annual Meeting. A biologist in a lab coat studying a culture of cells to find a cure for metabolic disorders. According to the release, ROSELLA met its primary endpoint of improved progression-free survival according to assessment by blinded independent central review (PFS-BICR). A 30% reduction in disease progression risk was recorded in patients who received relacorilant in addition to nab-paclitaxel chemotherapy as compared to those who received nab-paclitaxel monotherapy only. The results also showed that relacorilant plus nab-paclitaxel was well-tolerated and exhibited a comparable safety profile between treatment arms. Adding relacorilant did not cause a rise in patients' safety burden. In fact, patients who were administered relacorilant plus nab-paclitaxel experienced a lower incidence of ascites (5.3%) compared to those who received nab-paclitaxel alone (10.5%). The occurrence of abdominal paracenteses during treatment was also lower for the former patients. Corcept Therapeutics Incorporated (NASDAQ:CORT) is a biopharmaceutical company that develops and commercializes therapies that adjust the effects of cortisol, a hormone that regulates various bodily functions. The company's flagship product, Korlym, is FDA-approved for the treatment of Cushing's syndrome, a disorder characterized by excessive cortisol production. While we acknowledge the potential of CORT as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. 擷取數據時發生錯誤 登入存取你的投資組合 擷取數據時發生錯誤 擷取數據時發生錯誤 擷取數據時發生錯誤 擷取數據時發生錯誤
Associated Press
07-07-2025
- Business
- Associated Press
Apogee Therapeutics Announces Positive 16-Week Data from Phase 2 APEX Clinical Trial of APG777, its Potentially Best-in-Class Anti-IL-13 Antibody, in Moderate-to-Severe Atopic Dermatitis
APEX Part A met all primary and key secondary endpoints and exceeded trial objectives, including71.0%decrease from baseline in EASI at Week 16 APG777 demonstrated EASI-75 of 66.9% (42.5% placebo-adjusted) at Week 16, the highest topline and placebo-adjusted efficacy of any biologic in a global study Exposure-response relationship observed across multiple key endpoints; APEX Part B is testing higher exposureswith readout accelerated and now anticipated mid-2026, enabling planned Phase 3 initiation in 2026 APEX Part A testing potentially best in class 3- or 6-month maintenance dosing with 52-week readout anticipated 1H 2026 APG777 was well tolerated with a favorable safety profile consistent with other agents in class First patient dosed in APG279 (IL-13 + OX40L) Phase 1b head-to-head trial versus DUPIXENT with readout expected in 2H 2026 Management will host a conference call today at 8:00 a.m. ET SAN FRANCISCO and BOSTON, July 07, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, today announced positive 16-week data from Part A of the Phase 2 APEX clinical trial of APG777, a potential best-in-class anti-IL-13 antibody, in patients with moderate-to-severe atopic dermatitis (AD). 'With two out of every three patients treated with APG777 achieving EASI-75 response at Week 16 in the Phase 2 APEX Part A trial, APG777 demonstrated the highest EASI-75 response rate both on a topline and placebo-adjusted basis for any biologic in a global study to date, reinforcing its potential best-in-class profile for patients with moderate-to-severe atopic dermatitis,' said Michael Henderson, M.D., Chief Executive Officer of Apogee. 'APG777 has the potential to set a new standard of care by offering improved clinical responses with transformational quarterly or better maintenance dosing — benefitting patients, providers, and payers. Today's results bring us closer to that vision, and we believe further de-risks APG777's path to approval. In addition, I am excited for our two upcoming readouts to potentially even further improve on efficacy results — the accelerated APEX Part B testing higher exposures that is now expected to readout mid-2026, and the ongoing APG279 (IL-13 + OX40L) head-to-head trial against DUPIXENT expected to readout in the second half of 2026.' 'Today's results from APEX Part A demonstrate strong efficacy results across all key endpoints,' said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. 'In addition to these potentially best-in-class results, increased response rates were observed in patients with higher exposures, supporting our exposure-response hypothesis which we continue to further test in APEX Part B. Combined with a favorable safety profile, these findings reinforce APG777's potential to deliver meaningful and durable benefit to patients while significantly reducing dosing frequency compared with existing agents. On behalf of the entire Apogee team, I'd like to extend our gratitude to the patients and physicians for their support in the successful execution of this important trial.' APEX Phase 2 Part A Key 16-Week Results The Phase 2 APEX clinical trial is a randomized, placebo-controlled study evaluating APG777 in patients with moderate-to-severe AD. Part A of the trial enrolled 123 adult patients who were randomized 2:1 to APG777 versus placebo and received an induction regimen dosing of 720mg at Weeks 0 and 2, followed by 360mg at Weeks 4 and 12. Patients benefiting from treatment continued maintenance dosing, evaluating 3- or 6-month dosing of APG777. The primary endpoint of Part A is mean percentage change in Eczema Area Severity Index (EASI) score from baseline at Week 16. Secondary endpoints include EASI-75, EASI-90, Validated Investigator Global Assessment (IGA) 0/1 and Itch Numeric Rating Scale (NRS) at Week 16. Initial 16-week findings from APEX Part A include efficacy results, which compare favorably versus standard of care across endpoints as well as rapid onset of itch relief and lesion reduction, and a favorable safety profile consistent with its class: 'The Phase 2 Part A results are exciting, with APG777 demonstrating promising efficacy results from only four injection days over the initial 16-week induction period,' said Emma Guttman-Yassky, M.D., Ph.D., Waldman Professor of Dermatology and Immunology and Health System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City. 'Despite meaningful advances in atopic dermatitis treatment, there remains a significant unmet need to reduce the injection burden for patients while continuing to improve patient outcomes. I look forward to seeing the first half-life extended antibody in AD progress and I am excited about Apogee's studies that are bringing this therapy closer to patients.' APEX Part B is a placebo-controlled dose optimization with approximately 280 patients randomized 1:1:1:1 to high, medium, or low dose APG777 versus placebo. Part B continues to enroll participants with readout expected in mid-2026. Data readout from the maintenance phase of APEX Part A, testing 3- and 6-month maintenance dosing, is expected in the first half of 2026. Webcast Details Apogee Therapeutics' live webcast of the Phase 2 APEX Part A results will begin today at 8:00 a.m. ET. The live webcast can be accessed via this link or the Investors section on the Company's website at A replay of the webcast will be available following the call. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing optimized, novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of Atopic Dermatitis (AD), asthma, Chronic Obstructive Pulmonary Disease (COPD), Eosinophilic Esophagitis (EoE) and other I&I indications. Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the Company's most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the Company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care. For more information, please visit Forward Looking Statements Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee's plans for its current and future product candidates and programs; the expected timing of and results from its clinical trials, including 52-week maintenance data from Part A and the initial readout from Part B of its Phase 2 trial of APG777 in AD and initial readout from its Phase 1b trial of APG279 in AD; its planned clinical trial designs; its plans for current and future clinical trials, including the timing of initiation of a Phase 3 trial of APG777 in AD and potential path to regulatory approval; the potential clinical benefit and half-life, PK profile, dosing regimen, and treatment outcomes of APG777 and APG279; and its planned business strategies. Words such as 'may,' 'might,' 'will,' 'objective,' 'intend,' 'should,' 'could,' 'can,' 'would,' 'expect,' 'believe,' 'design,' 'estimate,' 'predict,' 'potential,' 'develop,' 'plan' or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee's filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the Company's control and subject to change. Actual or final results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of Apogee's preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee's clinical trials; the unpredictable relationship between preclinical study results and clinical trial results, including across different phases of clinical trials; the accuracy of cross-trial comparisons against products in the same class; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, and subsequent disclosure documents Apogee has filed and may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Investor Contact: Noel Kurdi VP, Investor Relations Apogee Therapeutics, Inc. [email protected] Media Contact: Dan Budwick 1AB Media [email protected]
Yahoo
06-07-2025
- Health
- Yahoo
Breakthrough gene therapy jab reverses hearing loss in weeks
A single jab of a breakthrough gene therapy could reverse hearing loss in people within weeks, according to new research. The cutting-edge therapy improved hearing in children and adults with congenital deafness or severe hearing impairment, with a 7-year-old regaining almost full hearing in a clinical trial, researchers from Sweden's Karolinska Institutet said. The clinical trial, detailed in the journal Nature Medicine, showed that a healthy copy of the OTOF gene injected in the inner ear improved hearing of all 10 participants. The small-scale trial included people who had a genetic form of deafness or severe hearing impairment caused by mutations in a gene called OTOF. These mutations cause a deficiency of the protein otoferlin, which plays a key role in transmitting sound signals from the ear to the brain. While the therapy seemed to work best in children, researchers said, it could benefit adults as well. In the trial, a synthetic, harmless version of the adeno-associated virus was used to deliver a properly functional OTOF gene to the inner ear via a single injection. The effects of the therapy were evident in the majority of patients, whose hearing recovered rapidly after just a month. After six months, researchers noted considerable hearing improvement in all participants, with their average volume of perceptible sound improving from 106 decibels to 52. Those between the ages of five and eight responded best to the treatment, the study found. One seven-year-old girl quickly recovered almost all her hearing, and she was able to hold daily conversations with her mother four months afterwards. 'This is the first time that the method has been tested in teenagers and adults,' Maoli Duan, an author of the study from Karolinska Institutet, said. "Hearing was greatly improved in many of the participants, which can have a profound effect on their life quality. We will now be following these patients to see how lasting the effect is.' Researchers also found that the treatment was safe and well-tolerated. Participants did not report any serious adverse reactions in the follow-up period of 6-12 months. The most common reaction was a reduction in the number of the immune system's neutrophils, a type of white blood cell. "OTOF is just the beginning," Dr Duan said, adding that researchers were working on other common genes behind deafness such as GJB2 and TMC1. 'These are more complicated to treat, but animal studies have so far returned promising results. We are confident that patients with different kinds of genetic deafness will one day be able to receive treatment.'
Yahoo
06-07-2025
- Health
- Yahoo
Breakthrough gene therapy jab reverses hearing loss in weeks
A single jab of a breakthrough gene therapy could reverse hearing loss in people within weeks, according to new research. The cutting-edge therapy improved hearing in children and adults with congenital deafness or severe hearing impairment, with a 7-year-old regaining almost full hearing in a clinical trial, researchers from Sweden's Karolinska Institutet said. The clinical trial, detailed in the journal Nature Medicine, showed that a healthy copy of the OTOF gene injected in the inner ear improved hearing of all 10 participants. The small-scale trial included people who had a genetic form of deafness or severe hearing impairment caused by mutations in a gene called OTOF. These mutations cause a deficiency of the protein otoferlin, which plays a key role in transmitting sound signals from the ear to the brain. While the therapy seemed to work best in children, researchers said, it could benefit adults as well. In the trial, a synthetic, harmless version of the adeno-associated virus was used to deliver a properly functional OTOF gene to the inner ear via a single injection. The effects of the therapy were evident in the majority of patients, whose hearing recovered rapidly after just a month. After six months, researchers noted considerable hearing improvement in all participants, with their average volume of perceptible sound improving from 106 decibels to 52. Those between the ages of five and eight responded best to the treatment, the study found. One seven-year-old girl quickly recovered almost all her hearing, and she was able to hold daily conversations with her mother four months afterwards. 'This is the first time that the method has been tested in teenagers and adults,' Maoli Duan, an author of the study from Karolinska Institutet, said. "Hearing was greatly improved in many of the participants, which can have a profound effect on their life quality. We will now be following these patients to see how lasting the effect is.' Researchers also found that the treatment was safe and well-tolerated. Participants did not report any serious adverse reactions in the follow-up period of 6-12 months. The most common reaction was a reduction in the number of the immune system's neutrophils, a type of white blood cell. "OTOF is just the beginning," Dr Duan said, adding that researchers were working on other common genes behind deafness such as GJB2 and TMC1. 'These are more complicated to treat, but animal studies have so far returned promising results. We are confident that patients with different kinds of genetic deafness will one day be able to receive treatment.'
