Significant improvement in 24-hour cough counts over placebo after 12 weeks of treatment and with a positive safety and tolerability profile / Results from PAGANINI Phase IIb dose-finding study presented at the virtual European Respiratory Society (ERS) International Congress 2021 / Currently no treatment approved for refractory chronic cough, a condition affecting one to 5 percent of individuals worldwide
Bayer today announced the results from PAGANINI, the Phase IIb dose-finding study evaluating the efficacy and safety of its investigational orally administered, potent and selective P2X3 receptor antagonist eliapixant (BAY1817080) in patients with refractory chronic cough (RCC). the first efficacy outcome was met showing a statistically significant reduction within the 24-hour cough count (average hourly cough frequency supported 24-hour sound recordings) of up to 27% for eliapixant 75 mg twice daily over placebo after 12 weeks of treatment. within the study, eliapixant demonstrated a positive benefit-risk profile, with the overwhelming majority of adverse events considered mild or moderate. Discontinuation of the study thanks to adverse events occurred in 8% of patients treated with eliapixant. Taste-related adverse events were reported in 24% of patients treated with the very best dose of eliapixant 150 mg twice daily and markedly less in patients receiving lower doses. Most were described as “a little” and “somewhat” bothersome, none described as “extremely” bothersome. The favourable tolerability of eliapixant during this trial is according to earlier clinical findings. As a result, eliapixant may have the potential for safe and effective long-term use.
RCC affects one to 5 percent of individuals worldwide and sometimes features a debilitating effect on the standard of patients’ lives. Currently, no treatment is approved for the therapy of RCC, and therefore the medical need for brand spanking new effective treatments is high.
“Given the high unmet medical need, we are very encouraged with the positive outcome of eliapixant within the chronic cough indication regarding efficacy and safety,” said Christian Rommel, Member of the chief Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “The selective mechanism of action of eliapixant appears to be translating into improved tolerability in clinical trials. These results will guide us to advance our clinical development strategy of eliapixant.”
“Chronic cough may be a common clinical condition with significant impact on quality of life and that effective therapy remains an unmet clinical need. Over the past decade, there has been a serious shift in how we approach this problem, driven by better appreciation of the clinical manifestation of chronic cough and an improved understanding of the associated neurobiology,” said Dr. Lorcan McGarvey, Professor of Respiratory Medicine, Wellcome-Wolfson Institute of Experimental Medicine, School of drugs , Dentistry and Biomedical Sciences, Queen’s University Belfast. “The findings from the PAGANINI trial with eliapixant are very encouraging, showing a promising outcome to deal with this unmet need. Such advancements are needed to supply new treatment options to patients with refractory chronic cough who are often suffering for several years without a relief.”
The results of the eliapixant PAGANINI study were presented at the virtual European Respiratory Society (ERS) International Congress 2021 (Abstract #BA23231).
About the Phase IIb Study
The Phase IIb study (PAGANINI, NCT04562155) is a world placebo controlled, randomized, double-blind, parallel group, dose-finding study to guage the efficacy, safety and tolerability of eliapixant compared to placebo in patients with RCC. during this study, 310 participants received either 25, 75 or 150 mg of eliapixant or placebo tablets twice daily for 12 weeks. Observation for every participant lasted about 18 weeks in total. Participants were asked to wear a digital device to record the cough and to finish questionnaires to document the symptoms subjectively. Blood samples were collected to watch safety and measure the blood level of the study drug.
Eliapixant (BAY1817080) is an investigational orally administered, potent and selective P2X3 receptor antagonist. The P2X3 receptor may be a key modulator of afferent nerve fibre signaling, thus considered to play a central role in diseases with nerve hypersensitization like cough hypersensitivity syndrome. P2X3 receptor antagonists block the receptor getting to decrease peripheral nerve fibre sensitivity. additionally to RCC, eliapixant is currently being evaluated in phase II clinical trial clinical trials for the treatment of endometriosis, overactive bladder and neuropathic pain. The P2X3 receptor antagonist was derived from Bayer’s former strategic alliance with Evotec SE, a worldwide drug discovery and development company.
About Refractory Chronic Cough (RCC)
The global prevalence of chronic cough is approximately 10 percent. The subtype of refractory chronic cough (RCC) affects one to 5 percent of all people worldwide. It doesn’t function an airway-protective mechanism, like physiologic cough, but is driven by a cough hypersensitivity syndrome. RCC disrupts patients’ lifestyle , causing them to cough between 10 to 100 times per hour with none external trigger and features a major impact on physical and psychological aspects of quality of life. repeatedly , the condition comes with an extended patient journey and time-to-diagnosis is on the average over 8 years. Currently, no treatment is approved for the therapy of RCC, and therefore the medical need for brand spanking new effective treatments is high.
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