Warszawski Uniwersytet Medyczny

German drugmaker Boehringer Ingelheim didn’t share any data behind the top-line result, instead promising that the efficacy and safety findings would be unveiled in the second quarter.\n Boehringer Ingelheim has cemented the potential of its idiopathic pulmonary fibrosis (IPF) drug with a second phase 3 win in a related lung disease leading the drugmaker to expand the indications it will seek FDA approval for.The FIBRONEER-ILD trial saw 1,178 patients with progressive pulmonary fibrosis (PPF) receive either a 9 mg or 18 mg dose of the PDE4B inhibitor nerandomilast or placebo twice a day for 52 weeks. The study hit its primary endpoint of demonstrating an absolute change from baseline in forced vital capacity—a measure of the volume of air that a patient can breathe out—Boehringer said in a Feb. 10 release.The German drugmaker didn’t share any data behind the top-line result, instead promising that the efficacy and safety findings would be unveiled in the second quarter.“Initial data readouts of the FIBRONEER trials support a generally consistent safety and tolerability profile when compared to the phase 2 IPF study, with overall adverse events comparable to those seen in the placebo group,” the company said.Armed with the latest results, Boehringer said it will request that FDA and global regulators approve nerandomilast as a treatment for PPF, a type of interstitial lung disease. The company has already said it will seek approval for nerandomilast in IPF after proclaiming a win in a phase 3 trial for that lung disease in September 2024. Again, the company opted to hold back any concrete data from that trial for later in this year.When it comes to managing IPF, physicians already have Boehringer’s Ofev and Roche’s Esbriet. However, those drugs only slow the progression of fibrosis, while attempts to produce molecules that further slow, or ideally stop, progression have failed to prove their worth.By targeting phosphodiesterase 4B (PDE4B), nerandomilast is meant to have a mechanistic advantage over the incumbent products. Targeting PDE4 drives anti-inflammatory and antifibrotic effects, but attempts to develop oral inhibitors of the enzyme in respiratory diseases have been hindered by class-related systemic adverse events such as diarrhea and headaches.“The positive FIBRONEER-ILD topline result shows the potential of nerandomilast in progressive pulmonary fibrosis,” Shashank Deshpande, Head of Human Pharma at Boehringer, said in the release. “The hope is that the safety and tolerability profile we are initially seeing could potentially help to reduce treatment challenges.”

TUESDAY, Aug. 6, 2024 -- Vestibular neurectomy is an effective vertigo treatment in patients with severe Meniere disease, according to a study published online June 7 in the Journal of Clinical Medicine . Agnieszka Jasińska-Nowacka, M.D., Ph.D., from the Medical University of Warsaw in Poland, and colleagues evaluated functional outcomes and balance compensation in patients with severe Meniere disease after vestibular neurectomy. The analysis included data from 20 patients with unilateral Meniere disease before and two years after vestibular neurectomy. The researchers found that all patients reported a complete resolution of vertigo attacks after the vestibular neurectomy, while 95 percent of patients reported functional-level improvement according to a scale proposed by the American Academy of Otolaryngology-Head and Neck Surgery. All patients showed clinical improvement in the Dizziness Handicap Inventory, with the average result decreasing from 81.7 to 16.4. There were no statistically significant differences between the sensory organization test results before and after vestibular neurectomy. There were significant correlations between a patient’s age and postoperative results of the Dizziness Handicap Inventory and posturography. "Vestibular neurectomy is an effective vertigo treatment in patients with severe Meniere disease with no clinical improvement despite conservative treatment," the authors write. "It results in subjective physical, functional, and emotional improvement, enabling patients to return to daily activities and work." Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

MONDAY, Aug. 5, 2024 -- For patients with Meniere disease (MD), vestibular neurectomy is effective, resolving vertigo episodes and resulting in hydrops regression, according to a study published online July 30 in Acta Neurologica Belgica . Agnieszka Jasińska-Nowacka, M.D., Ph.D., from the Medical University of Warsaw in Poland, and colleagues assessed endolymphatic hydrops in patients with severe MD before and after vestibular neurectomy. Magnetic resonance imaging was performed before and after vestibular neurectomy in 20 patients with unilateral definite MD. The researchers found that in all patients, endolymphatic hydrops were visualized in the preoperative scans. All patients presented a complete resolution of vertigo episodes after the vestibular neurectomy. Analyzing the cochlea and vestibule, regression of the endolymphatic hydrops was observed in 35 and 15 percent of cases, respectively. Withdrawal of the hernia was visualized in 71.43 percent of patients with utricular herniation into the lateral semicircular canal. In 17.64 percent of cases, asymmetrical contrast enhancement in the cochlea regressed. Analyzing all parameters collectively, partial regression of at least one of the radiological signs was confirmed in the follow-up examination in 60 percent of patients. After the surgery, no progression of the endolymphatic hydrops was visualized in either the cochlea or the vestibule. "Although it is known to be an effective symptomatic treatment of vertigo attacks, vestibular neurectomy may also effectively halt the progression of the endolymphatic space dilatation and result in hydrops regression," the authors write. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.