There is a misconception that Bellus is lacking catalysts following their strong Phase 1 data released last week (read here). We don’t necessarily agree with the lack of catalyst argument and will be discussing the upcoming events to look forward to in 2019.
Cough Competitors Will Be Presenting Data
NeRRE Phase 2 Chronic Cough Readout Expected Q1 2019
Private company NeRRE Therapeutics will be completing their Phase 2b study in chronic cough patients by December 2018. This study has enrolled 244 patients and measuring cough frequency as primary endpoint (study details here).
NeRRE’s candidate is a NK-1 antagonist that blocks the NK-1 receptor and hinders the signaling process, which in turn is expected to improve urges like coughing and itching. In a proof of concept Phase 2 study (n=13), NeRRe’s Orvepitant demonstrated a 28% reduction in cough after 8 weeks. We expect Phase 2b readout in Q1 2019.
Remember, Menlo’s (MNLO) serlopitant, also a NK-1 antagonist, failed Phase 2 (n=185) in chronic cough with 31% reduction and was outperformed by placebo. Menlo discontinued development after this failure. With Menlo’s failure and NeRRe’s subpar Phase 1 data, NK-1 candidates are indicating they are not as effective as P2X3 in reducing cough.
Bayer Chronic Cough Readout Expected Late Q3- Early Q4 2019
Bayer is developing a selective P2X3 candidate that is currently in a 2 part Phase 2 study (read details here). Part 1 is a safety and ascending multiple dose study. Part 2 is a cross over study to test efficacy. Both parts are expected to be completed July 2019. We expect data to be released sometime late Q3 or early Q4.
Bayer’s studies have been similarly designed to Merck’s (and Bellus) for the same chronic cough indication. This means that data, when released, can be compared head to head. Although Bayer’s candidate is also a selective P2X3 candidate, it is believed to be as much as 125x more selective for P2X3, versus the cousin taste receptor P2X2/3. Bellus’ candidate is 1500x. Theoretically, this means that Bayer should have an improved taste profile vs Merck. The big questions are: how much better is the taste effect vs Merck? Is it comparable to Bellus?
Bayer has been very private with their P2X3 candidate thus far. We believe more clarity will be given late 2019 when they release data on safety, efficacy and taste.
What these catalysts mean for Bellus: 2019 competitor data readouts will provide clarity on the chronic cough landscape. This data could further validate the P2X3 drug class as the most effective in targeting chronic cough, and position Bellus as the best-in-class candidate.
Merck’s P2X3 Candidate Will Present Data In Other Indications
Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI)
Merck has expanded gefapixant, their P2X3 program, into other indications. Currently, a Phase 2, 188 patient trial is being conducted for acute cough in patients with URTI (trial details here). The study is estimated to be completed in June 2019, so we expect readout sometime in Q3 2019.
It is important to note that Merck is testing the 45mg dose in these acute cough patients. Remember, their Phase 3 in chronic cough is testing 15mg & 45mg, with the hopes of the lower 15mg dose showing less of a taste side effect. We think 45mg will be the therapeutic dose in chronic cough and taste will remain a burden. The 45mg dosing in acute cough supports our thinking.
Women With Endometriosis-Related Pain
Merck is also testing gefapixant in a Phase 2, 166 patient study for women with endometriosis-related pain (trial details here). This study is expected to be completed in October 2019. We expect data to be released in Q4 2019.
What these catalysts mean for Bellus: Merck’s strategy with gefapixant lays a foundation for Bellus to follow if/when the company decides to expand their pipeline beyond chronic cough. In our view, this is a de-risked and economic R&D strategy that Bellus could shadow. Merck’s data in other indications will hint at how Bellus’ candidate would perform, given the similar mechanism of action between gefapixant and BLU-5937.
Insider Purchases Show Vote of Confidence
Bellus traded down after the market misinterpreted their promising Phase 1 data (read our analysis here). Bellus insiders took this opportunity to buy the dip and instill confidence in their data. CEO Roberto Bellini purchased 100,000 shares for a total of $91,800 and Chairman Francesco Bellini acquired 200,000 in the open market for a total of $167,950.
Cough Competitors Will Be Presenting Data
NeRRE Phase 2 Chronic Cough Readout Expected Q1 2019
Private company NeRRE Therapeutics will be completing their Phase 2b study in chronic cough patients by December 2018. This study has enrolled 244 patients and measuring cough frequency as primary endpoint (study details here).
NeRRE’s candidate is a NK-1 antagonist that blocks the NK-1 receptor and hinders the signaling process, which in turn is expected to improve urges like coughing and itching. In a proof of concept Phase 2 study (n=13), NeRRe’s Orvepitant demonstrated a 28% reduction in cough after 8 weeks. We expect Phase 2b readout in Q1 2019.
Remember, Menlo’s (MNLO) serlopitant, also a NK-1 antagonist, failed Phase 2 (n=185) in chronic cough with 31% reduction and was outperformed by placebo. Menlo discontinued development after this failure. With Menlo’s failure and NeRRe’s subpar Phase 1 data, NK-1 candidates are indicating they are not as effective as P2X3 in reducing cough.
Bayer Chronic Cough Readout Expected Late Q3- Early Q4 2019
Bayer is developing a selective P2X3 candidate that is currently in a 2 part Phase 2 study (read details here). Part 1 is a safety and ascending multiple dose study. Part 2 is a cross over study to test efficacy. Both parts are expected to be completed July 2019. We expect data to be released sometime late Q3 or early Q4.
Bayer’s studies have been similarly designed to Merck’s (and Bellus) for the same chronic cough indication. This means that data, when released, can be compared head to head. Although Bayer’s candidate is also a selective P2X3 candidate, it is believed to be as much as 125x more selective for P2X3, versus the cousin taste receptor P2X2/3. Bellus’ candidate is 1500x. Theoretically, this means that Bayer should have an improved taste profile vs Merck. The big questions are: how much better is the taste effect vs Merck? Is it comparable to Bellus?
Bayer has been very private with their P2X3 candidate thus far. We believe more clarity will be given late 2019 when they release data on safety, efficacy and taste.
What these catalysts mean for Bellus: 2019 competitor data readouts will provide clarity on the chronic cough landscape. This data could further validate the P2X3 drug class as the most effective in targeting chronic cough, and position Bellus as the best-in-class candidate.
Merck’s P2X3 Candidate Will Present Data In Other Indications
Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI)
Merck has expanded gefapixant, their P2X3 program, into other indications. Currently, a Phase 2, 188 patient trial is being conducted for acute cough in patients with URTI (trial details here). The study is estimated to be completed in June 2019, so we expect readout sometime in Q3 2019.
It is important to note that Merck is testing the 45mg dose in these acute cough patients. Remember, their Phase 3 in chronic cough is testing 15mg & 45mg, with the hopes of the lower 15mg dose showing less of a taste side effect. We think 45mg will be the therapeutic dose in chronic cough and taste will remain a burden. The 45mg dosing in acute cough supports our thinking.
Women With Endometriosis-Related Pain
Merck is also testing gefapixant in a Phase 2, 166 patient study for women with endometriosis-related pain (trial details here). This study is expected to be completed in October 2019. We expect data to be released in Q4 2019.
What these catalysts mean for Bellus: Merck’s strategy with gefapixant lays a foundation for Bellus to follow if/when the company decides to expand their pipeline beyond chronic cough. In our view, this is a de-risked and economic R&D strategy that Bellus could shadow. Merck’s data in other indications will hint at how Bellus’ candidate would perform, given the similar mechanism of action between gefapixant and BLU-5937.
Insider Purchases Show Vote of Confidence
Bellus traded down after the market misinterpreted their promising Phase 1 data (read our analysis here). Bellus insiders took this opportunity to buy the dip and instill confidence in their data. CEO Roberto Bellini purchased 100,000 shares for a total of $91,800 and Chairman Francesco Bellini acquired 200,000 in the open market for a total of $167,950.
PropThink contributors are LONG BLUSF
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