It seems the market is starting to realize Bellus’ potential as the company touched a 52 week high today on the Canadian listing when it hit $1.30/share. Trading volume has been above average these last few trading days, indicating that investors are jumping into the name with the company preparing its Phase 2 in chronic cough.
Remember, Bellus announced promising Phase 1 data (read here) that validated their P2X3 candidate as a potentially superior alternative to Merck’s own drug for chronic cough. In this note, we’ll give an update on Bellus’ catalysts for 2019.
Bellus Phase 2 Initiation Mid-2019 & Topline Data Mid-2020
We expect Bellus to begin enrolment of their Phase 2 crossover trial in chronic cough around mid-2019. This trial will enroll 50 chronic patients in the US/UK and test 25, 50, 100, 200mg twice daily.
The company anticipates that the therapeutic dose will be between 50-100mg. Given that BLU-5937 is more potent than Merck’s gefapixant, and that Merck’s Phase 3 dosing is 15mg/45mg, we think Bellus’ projected therapeutic dose of 50-100mg is accurate. This bodes well for taste side effects, which were less than 5% (read here) in the sub-200mg doses. For comparison sakes, Merck showed 80% of patients experienced a taste side effect.
Cough Competitor NeRRe Data Readout Pushed Back
Initially, NeRRe was expected to put out Phase 2 data in chronic cough by Q1 2019. The latest update on clinicaltrials.gov showed that the study would be completed by the end of January 2019. We expect readout in Q2 2019, after an approx. 60 day data cleanout period.
We have pretty low expectations for NeRRe’s upcoming readout due to the lack of efficacy from other NK-1 candidates (read analysis here).
Merck Pulls Plug on Acute Cough, Still Testing In Endometriosis-related Pain
Merck expanded gefapixant, their P2X3 program, into other indications outside chronic cough. A Phase 2 trial was conducted for acute cough in patients with URTI (trial details here). An update on clinicaltrials.gov showed that interim efficacy data did not support study endpoints for acute cough. As a result, Merck terminated the trial.
The lack of efficacy on acute cough does not bode well for any of the P2X3 candidates, including Bellus’. This means one less pipeline indication that Bellus could expand to. Overall, this is disappointing news for Bellus and other P2X3 candidates. We will be looking to see why Merck’s data flopped when they present at an upcoming cough conference.
Merck is continuing their Phase 2 trial in women with endometriosis-related pain (trial details here). This study is expected to be completed in October 2019. We expect data to be released late Q4 2019.
Bellus’ Plans to Uplist to National Exchange
With the recent financing out of the way, we think the next capital markets task for Bellus is to list on a national exchange such as the Nasdaq. The company has mentioned that this could be in the plans during the second half of 2019, after the initiation of Phase 2 trial.
PropThink contributors are LONG BLUSF
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