Nerandomilast

UK NHS, Boehringer Ingelheim Taiwan adopt Coreline Soft imaging AI South Korean imaging AI developer Coreline Soft has recently bagged multiple supply contracts in the United Kingdom, Europe, and Taiwan. It has obtained its first contract with the UK's National Health Service (NHS) to provide its AI-powered medical image analysis software AVIEW for the Eastern Diagnostic Imaging Network project, a collaboration of NHS Trusts in East England. The software will be deployed to 12 hospitals, including Cambridge University Hospital, for health screening and general CT examinations. The company was also named the exclusive provider of an AI image analysis software for the national lung cancer screening project of the French National Cancer Institute (Institut National du Cancer). Host hospitals, Assistance Publique – Hôpitaux de Paris and Lyon City Hospital, chose Coreline Soft's AI-powered lung cancer screening solution, which can detect pulmonary nodules, emphysema, and coronary artery calcification in a single chest CT scan. Moreover, Coreline Soft will deliver its AI software module for identifying lung deformation patterns to partner hospitals of Boehringer Ingelheim Taiwan as part of a program to test and verify anti-fibrotic drugs. The pharmaceutical company will use the lung pattern analysis module, which automatically links chest CT analysis reports to PACS and RIS in near real time, to quickly identify eligible patients with interstitial lung disease and abnormalities for clinical trials of Ofev (nintedanib) and the investigational drug nerandomilast. VUNO receives EU MD, UKCA marks Fellow Korean medical AI company, VUNO, has obtained the European Union's Medical Device Regulation certification and the UK Conformity Assessed mark for its flagship AI-powered cardiac arrest risk assessment tool. In a statement, the company said these new regulatory clearances will allow it to prepare for similar certifications in the Middle East, aiming to complete registration within the year and begin supplying its software across hospitals in the region by next year. VUNO's cardiac arrest risk assessment software, which is currently used in over 130 hospitals in South Korea, has pending clearance from the United States Food and Drug Administration. In 2023, it was given a breakthrough device designation by the same regulator. Hong Kong OKs AITRICS's patient deterioration prediction AI Another medical AI company from South Korea, AITRICS, also announced its medical device approval from the Hong Kong government. It has received the Hong Kong Medical Device Division's clearance for its AI software, which analyses EMR data to predict patients' risk of major adverse events, including sepsis, cardiac arrest, ICU transfer, and death, within four to six hours. This is its fourth regulatory approval following clearances from South Korea, the United States, and Vietnam. 510(k) for paediatric use of smart wearable stethoscope Singaporean company Aevice Health has obtained the US FDA's 510(k) clearance for the expanded use of its smart wearable stethoscope for remote respiratory monitoring in children aged 3 years and above. The medical device maker received its first 510(k) for its AI-powered solution in 2023. Early this year, it received late seed investment from chemical manufacturer Denka through Pegasus Tech Ventures and venture capital firm Elev8. The company has raised a total of $9.1 million in reported investments since 2021.

Boehringer Ingelheim (BI) has unveiled results from two late-stage studies of nerandomilast in idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The phase 3 FIBRONEER-IPF and FIBRONEER-ILD trials have been evaluating the candidate in patients with IPF and PPF, respectively, with and without background anti-fibrotic therapy. Results presented at this year’s American Thoracic Society International Conference showed that the trials met their primary endpoint at both doses, with nerandomilast 9mg and 18mg significantly reducing decline in forced vital capacity, a measure of lung function, by absolute change from baseline at week 52 compared to placebo. Neither study met the composite key secondary endpoint of time to first acute IPF/interstitial lung disease (ILD) exacerbation, first hospitalisation for respiratory cause or death, BI said. However, the company outlined that death occurred in a “numerically smaller” proportion of patients treated with nerandomilast than placebo in FIBRONEER-ILD. Similar rates of permanent treatment discontinuation to placebo were observed across both trials, with adverse events in FIBRONEER-IPF leading to permanent discontinuation of the trial regimen in 14% of patients in the nerandomilast 18mg group, 11.7% of those in the nerandomilast 9mg group and 10.7% of the placebo group. In FIBRONEER-ILD, 10% in the nerandomilast 18mg group, 8.1% in the nerandomilast 9mg group, and 10.2% in the placebo group discontinued the trial regimen due to adverse events. IPF, which primarily affects adults aged over 50 years, is one of the more common progressive fibrosing ILDs. The condition causes the lungs to become scarred and results in symptoms such as breathlessness during activity, a dry and persistent cough, fatigue and weakness. Patients with specific types of non-IPF fibrosing ILD may also go on to develop PPF, characterised by worsening respiratory symptoms, as well as physiological and radiological evidence of disease progression. Nerandomilast is an orally-administered preferential inhibitor of phosphodiesterase 4B and is currently under review for IPF and PPF in the US, EU and China. Shashank Deshpande, head of human pharma and member of the board of managing directors at BI, said: “IPF and PPF are devastating conditions, with one in two people dying within five years of IPF diagnosis. Despite this stark reality, ongoing research may provide new possibilities for patients, as there remains a need for additional therapies. “The latest efficacy, safety and tolerability data on nerandomilast points to its potential in addressing the needs of those impacted by IPF and PPF.”