Aug 10, 2020
Table of Contents
ATS 2020 Virtual is happening from August 5 to August 10, and it is exciting to watch major Respiratory /Pulmonary Pharmaceutical companies and their key presentations.
Merck is worth mentioning here, as it is presenting key posters and studies on Gefapixant in Chronic Refractory Cough (CRC).
Click Here To Get the Article in PDF
Gefapixant History:
In July 2016, Merck acquired MK-7264 from Afferent Pharmaceuticals by signing a definitive agreement to USD 1.25 billion.
Gefapixant Facts:
Session Title: D93 – EVALUATION AND NOVEL TREATMENT APPROACH FOR CHRONIC COUGH
Title – Dose Selection for Two, Phase III, Randomized Controlled Trials (Cough-1 and Cough-2) in Refractory or Unexplained Chronic Cough
Session Summary: The agenda of this study was to identify at least one dose of Gefapixant that achieves a favorable balance of efficacy and safety/tolerability. Gefapixant 15mg would provide a clinically meaningful reduction in cough frequency with minimal incidence of taste –related AEs and minimal rate of discontinuations. A higher dose of the drug in 45mg is predicted to provide maximal reduction in cough frequency with an acceptable rate of taste –related AEs as well as acceptable rates of discontinuations.
Session Title: D104 – Phenotypes, Prognostic Tools, and Adjunct Therapies in Cough, Cf And Non-Cf Bronchiectasis
Title – A Phase IIIb Trial Evaluating the Efficacy of Gefapixant in Reducing Stress Urinary Incontinence in Women with Chronic Cough
Session Summary: Merck announced the initiation of a Phase IIIb trial (NCT04193176) to evaluate the efficacy of Gefapixant in Reducing Stress Urinary Incontinence in Women with Chronic Cough. The company has worked on a unique trial design as it is targeting patients with Cough Induced stress Urinary Incontinence (SUI), which is a common condition associated with Chronic Cough. Repetitive daily increases in intra-abdominal pressure caused by Chronic Cough may contribute to SUI, therefore, treatment of Chronic Cough may improve cough induced SUI by alleviating the underlying increased pressure.
Session Title: D93 – EVALUATION AND NOVEL TREATMENT APPROACH FOR CHRONIC COUGH
Title- Responder Analyses Evaluating Treatment Effects over Time with Gefapixant in a Phase IIb Study of Refractory or Unexplained Chronic Cough
Session Summary– A 12 week Responder analysis study illustrated dose response , with more patients on Gefapixant 50mg vs placebo or the lower dose of 7.5mg and 20mg achieving clinically important reductions in cough frequency and clinically important improvement in Cough severity at Week 4, 8 and 12. The population of responders according to the endpoint –specific definitions were largely consistent, with the highest consistency observed in the gefapixant 50mg group
Although an early-stage player, Bayer is worth mentioning here, as it has presented its key poster on Chronic Refractory Cough.
History: In July 2019, Evotec SE announced that the Company has been notified by its partner Bayer about the successful outcome of a combined Phase I/IIa study with the P2X3 antagonist BAY1817080, originating from the Evotec/Bayer multi-target alliance. The objective of the study was to evaluate the safety, efficacy, and dose range of BAY1817080 in patients with refractory chronic cough.
BAY1817080 Facts:
Title – Safety and Efficacy of BAY-1817080, a P2X3 Receptor Antagonist, in Patients with Refractory Chronic Cough.
S-600918 Facts:
#Abstract A7647 (Thursday)
Title – Phase IIa Randomized, Double-Blind, Placebo-Controlled, Crossover Study of a P2x3 Receptor Antagonist S-600918: Effects on Health-Related Quality of Life in Patients with Refractory Chronic Cough
Session Summary- S-600918 improved multiple subjective endpoints after 2 weeks of administration. These observations, combined with the efficacy results to reduce objective cough as previously reported, suggested the positive impact of S-600918 on quality of life in patients with Chronic Refractory Cough. These findings warrant further investigation with larger population samples.
Analyst Comment- Based on the promising safety and tolerability results of S-600918 in the Phase II study presented at European Respiratory Society International Congress (ERS 2019),Shionogi Pharma was adherent in conducting a multiregional Phase IIb study. In ATS 2020, the company concluded that their drug is creating a positive impact on the overall quality of life of these patients all over the world as a drug-discovery-based pharmaceutical company.
Article in PDF
Aug 10, 2020
Table of Contents
ATS 2020 Virtual is happening from August 5 to August 10, and it is exciting to watch major Respiratory /Pulmonary Pharmaceutical companies and their key presentations.
Merck is worth mentioning here, as it is presenting key posters and studies on Gefapixant in Chronic Refractory Cough (CRC).
Gefapixant History:
In July 2016, Merck acquired MK-7264 from Afferent Pharmaceuticals by signing a definitive agreement to USD 1.25 billion.
Gefapixant Facts:
Session Title: D93 – EVALUATION AND NOVEL TREATMENT APPROACH FOR CHRONIC COUGH
Title – Dose Selection for Two, Phase III, Randomized Controlled Trials (Cough-1 and Cough-2) in Refractory or Unexplained Chronic Cough
Session Summary: The agenda of this study was to identify at least one dose of Gefapixant that achieves a favorable balance of efficacy and safety/tolerability. Gefapixant 15mg would provide a clinically meaningful reduction in cough frequency with minimal incidence of taste –related AEs and minimal rate of discontinuations. A higher dose of the drug in 45mg is predicted to provide maximal reduction in cough frequency with an acceptable rate of taste –related AEs as well as acceptable rates of discontinuations.
Session Title: D104 – Phenotypes, Prognostic Tools, and Adjunct Therapies in Cough, Cf And Non-Cf Bronchiectasis
Title – A Phase IIIb Trial Evaluating the Efficacy of Gefapixant in Reducing Stress Urinary Incontinence in Women with Chronic Cough
Session Summary: Merck announced the initiation of a Phase IIIb trial (NCT04193176) to evaluate the efficacy of Gefapixant in Reducing Stress Urinary Incontinence in Women with Chronic Cough. The company has worked on a unique trial design as it is targeting patients with Cough Induced stress Urinary Incontinence (SUI), which is a common condition associated with Chronic Cough. Repetitive daily increases in intra-abdominal pressure caused by Chronic Cough may contribute to SUI, therefore, treatment of Chronic Cough may improve cough induced SUI by alleviating the underlying increased pressure.
Session Title: D93 – EVALUATION AND NOVEL TREATMENT APPROACH FOR CHRONIC COUGH
Title- Responder Analyses Evaluating Treatment Effects over Time with Gefapixant in a Phase IIb Study of Refractory or Unexplained Chronic Cough
Session Summary– A 12 week Responder analysis study illustrated dose response , with more patients on Gefapixant 50mg vs placebo or the lower dose of 7.5mg and 20mg achieving clinically important reductions in cough frequency and clinically important improvement in Cough severity at Week 4, 8 and 12. The population of responders according to the endpoint –specific definitions were largely consistent, with the highest consistency observed in the gefapixant 50mg group
Although an early-stage player, Bayer is worth mentioning here, as it has presented its key poster on Chronic Refractory Cough.
History: In July 2019, Evotec SE announced that the Company has been notified by its partner Bayer about the successful outcome of a combined Phase I/IIa study with the P2X3 antagonist BAY1817080, originating from the Evotec/Bayer multi-target alliance. The objective of the study was to evaluate the safety, efficacy, and dose range of BAY1817080 in patients with refractory chronic cough.
BAY1817080 Facts:
Title – Safety and Efficacy of BAY-1817080, a P2X3 Receptor Antagonist, in Patients with Refractory Chronic Cough.
S-600918 Facts:
#Abstract A7647 (Thursday)
Title – Phase IIa Randomized, Double-Blind, Placebo-Controlled, Crossover Study of a P2x3 Receptor Antagonist S-600918: Effects on Health-Related Quality of Life in Patients with Refractory Chronic Cough
Session Summary- S-600918 improved multiple subjective endpoints after 2 weeks of administration. These observations, combined with the efficacy results to reduce objective cough as previously reported, suggested the positive impact of S-600918 on quality of life in patients with Chronic Refractory Cough. These findings warrant further investigation with larger population samples.
Analyst Comment- Based on the promising safety and tolerability results of S-600918 in the Phase II study presented at European Respiratory Society International Congress (ERS 2019),Shionogi Pharma was adherent in conducting a multiregional Phase IIb study. In ATS 2020, the company concluded that their drug is creating a positive impact on the overall quality of life of these patients all over the world as a drug-discovery-based pharmaceutical company.