September 13, 2017

Hits and Misses from the Cough Conferences – Part 2: Summary from American Cough Conference

Here are the three hits and one miss from the American Cough Conference:

Hit: Conference itself was GREAT

While we sent one representative to the American Thoracic Society conference, there were three of us at the American Cough Conference due to its almost exclusive focus on chronic cough. The agenda was packed with presentations of high interest to our team (animal cough models, cough recorders, running clinical studies, etc.) and was very relevant to our chronic cough therapy development program, BLU-5937. Speakers were the best in the field and debate during Q&A was lively and informative.

Hit (mostly): Merck Cough Data

As reported in my previous blog (link), Merck presented data from a Phase IIb study with their own P2X3 antagonist which was very positive in terms of efficacy - a 84% reduction in awake cough frequency - but had a problematic side effect, with 80% of patients reporting some form of taste alteration and/or taste loss at the effective dose.

Hit: Tools to Measure Chronic Cough

Currently available tools to objectively measure cough frequency are reliable, but they could get even better in the medium-term. While there isn’t a formal regulatory position on the endpoint required for chronic cough drug approval (the FDA has not approved a drug for this indication for more than 50 years), there is a consensus that reduction in cough frequency as measured by a validated cough recorder will likely be the approval endpoint accepted by FDA. A cough recorder has been successfully used in all the Afferent and Merck studies with strong alignment between reduction in number of coughs and patient-assessed disease severity.

Cough recorders have limitations (they are limited to sound), and in the future wearable devices could provide an even more sensitive measure of coughing by recording factors such as cough pitch, motion and muscle effort. Advanced tools that record cough characteristics in addition to frequency can capture more clinical data points, ultimately supporting the development of chronic cough drug candidates.

Miss (mostly): New Treatment Approaches to Chronic Cough

Other therapeutic approaches to treating chronic cough currently at development stage include Neurokinin (NK) inhibitors, Neuronal Nicotinic Receptor (NNR) antagonists and Transient Receptor Potential (TRP) antagonists. These approaches don’t seem to be gaining a lot of traction, likely due to weaker efficacy and side effect concerns. Interestingly, speech therapy is a non-drug approach that was further emphasized at the conference as an area of interest, particularly in conjunction with other pharmacological approaches.

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For more info on chronic cough, please join our live webcast on September 20th at 2pm EST (details below). KOL Dr. Jacky Smith will be presenting on chronic cough and Bellus management will also provide an update on BLU-5937, our P2X3 antagonist for chronic cough, including recent preclinical study results. There will be time for a Q&A so should be a great discussion.

To listen to the live webcast or to ask questions during the live event, please register at the following link: https://event.webcasts.com/starthere.jsp?ei=1159556&tp_key=4a0ae58b66. To ensure a timely connection to the webcast, it is recommended that listeners pre-register no later than 15 minutes prior to the scheduled start time. An archived version of the webcast and presentation will be available on the Company's website at www.bellushealth.com following the event.

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