AUDIOCURE-PHARMA-GMBH
12.3.2024 11:37:31 CET | Business Wire | Press release
High-dose glucocorticoids are no more effective than the standard-dose in treating patients with sudden hearing loss. They are also associated with more side effects and significantly worse outcomes for speech recognition and tinnitus perception. Additionally, 60% of patients treated with the standard dose had not fully recovered by the end of the study. This clinical study, led by Prof. Stefan Plontke from the University Medicine Halle, evaluated the efficacy of different doses of glucocorticoids in over 300 sudden hearing loss patients and is published in NEJM Evidence. These results raise the possibility that glucocorticoids may not be sufficiently effective in treating this condition.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240312579935/en/
Prof. Stefan Plontke, principal investigator of the study at the University Medical Center Halle (Photo: University Medicine Halle).
Sudden hearing loss can drastically impair speech understanding and affect a patient’s daily life. Glucocorticoids are prescribed worldwide as the standard-of-care. However, in certain circumstances their side effects can be severe, and it remains unclear whether they provide meaningful improvement for patients. "These drugs have been used globally for 50 years as the standard of care for sudden hearing loss, still there is no reliable scientific evidence for this practice.", explains study leader Stefan Plontke, underscoring the increasing need for new treatments. Many companies are exploring alternatives. However, there is currently only one clinical trial with a new active substance in which patients can participate: The compound AC102 outperformed the widely used cortisone-like dexamethasone in preclinical models of hearing loss, likely because it specifically targets damaged sensory cells and the auditory nerve. Clinical trials are now testing whether this effect is comparable in humans. "We are not surprised by the HODOKORT study results. Glucocorticoids as anti-inflammatory drugs are a good treatment option for many conditions. However, there is no convincing mode-of-action for the treatment of sudden hearing loss with steroids, as our own research has shown," says Dr. Reimar Schlingensiepen, CEO of AudioCure Pharma.
After 50 years of treating sudden hearing loss with glucocorticoids, a new and effective drug for this condition would represent a much-needed paradigm shift.
Original Study: Plontke, et al. NEJM Evid 2024;3(1) DOI:10.1056/EVIDoa2300172
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240312579935/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Ningbo FEED Meeting Confirms Full Confidence in Q1 2027 FID for Allied Biofuels’ US$6.1 Billion Presidential Decree-Backed SAF and e-SAF Project18.9.2026 17:38:00 CEST | Press release
Allied Biofuels has held a major Front-End Engineering Design (FEED) meeting at Sinopec’s office in Ningbo, China, bringing together Allied Biofuels, Sinopec Engineering Group Co., Ltd. of China, Topsoe A/S of Denmark, Sasol South Africa Limited, and Plug Power of the United States — the principal international engineering and technology providers supporting its US$6.1 billion Presidential Decree-backed Sustainable Aviation Fuel (SAF) and e-SAF project in Uzbekistan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918708077/en/ FEED Meeting - Ningbo, China At the joint FEED meeting of the project’s core engineering and technology stakeholders, the discussions established clear alignment on engineering responsibilities, technology interfaces, design deliverables, project integration and the coordinated execution programme required to advance the project through FEED. All stakeholders working on the project expressed full co
Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli® (Relacorilant)18.9.2026 14:00:00 CEST | Press release
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) should approve relacorilant, combined with the chemotherapy drug nab-paclitaxel, for the treatment of patients with platinum-resistant ovarian cancer. The CHMP’s recommendation is based on positive data from Corcept’s Phase 2 and pivotal Phase 3 ROSELLA trials, in which patients receiving relacorilant combined with nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel alone. The safety profile of relacorilant plus nab-paclitaxel in these trials was consistent with the safety profile of nab-paclitaxel monoth
Enhertu® Recommended for Approval in the EU by CHMP as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer18.9.2026 14:00:00 CEST | Press release
Recommendation based on DESTINY-Breast05 phase 3 trial results that showed Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 Daiichi Sankyo and AstraZeneca’s Enhertu has the potential to become a new standard of care in this early breast cancer setting Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2 positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2 targeted treatment. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast05 phase 3 trial presented at th
CHMP Recommends EU Approval of New Indication for Alfasigma’s Jyseleca® (filgotinib), Treatment of Adults With Axial Spondyloarthritis18.9.2026 12:58:00 CEST | Press release
The information contained within this press release is for the purpose of scientific exchange.It is intended for scientific, financial and investor media only.If approved, Jyselecawill be indicated for the treatment of patients with active axial spondyloarthritis (axSpA), both non-radiographic and radiographic forms of the disease, who have responded inadequately to conventional therapy.Despite the availability of multiple treatment options, nearly half of people living with axSpA do not respond adequately to current therapies, and just 10-20% reach inactive disease within 16-24 weeks of initiating treatment.CHMP’s positive opinion is based on findings from the OLINGUITO Phase 3 study, where improvements in the signs and symptoms of axSpA with filgotinib were observed early and maintained over 52 weeks of treatment.Jyselecais already approved in Europe and the United Kingdom, for the treatment of moderate to severe rheumatoid arthritis and ulcerative colitis. Alfasigma S.p.A, a global
IMPACT Therapeutics and Pharmanovia Announce Positive CHMP Opinion for Senaparib, as a Potential First-Line Maintenance Treatment of Advanced High-Grade Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer18.9.2026 12:38:00 CEST | Press release
For business and medical media only This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918325771/en/ Stephan Eder, CEO, Pharmanovia IMPACT Therapeutics (07630.HK), a commercial-stage biotechnology company focused on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality mechanisms, together with global specialty pharmaceutical company Pharmanovia, today jointly announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a Marketing Authorisation (MA) for the medicinal product Sepalna® (senaparib) intended for the maintenance treatment of advance epithelial ovarian, fallopian tube and primary peritoneal cancer. Following the CHMP’s recommendation for approval, senaparib will be submitted to the European Commission (EC) for final decision. Once approved by the EC, senaparib will
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom