Menlo (MNLO), a company developing serlopitant for chronic cough candidate, reported disappointing Phase 2 data. In 185 patients, serlopitant group had 31% less reduction than the placebo group. In their secondary endpoint, 54% of placebo treated patients and 44% of serlopitant treated patients experienced a 30% or greater reduction in 24-hour cough frequency at week 12 compared to baseline.
Menlo’s candidate could not outperform placebo, and as a result, the company discontinued development of serlopitant for chronic cough.
What Does This Mean for Bellus?
Menlo’s data suggests that the NK-1 drug class is not as effective as P2X3 in reducing cough. Menlo’s candidate was a NK-1 antagonist, a drug class that was furthest in development after P2X3.
NeRRe therapeutics, a private company developing another NK-1 candidate, is currently in Phase 2(n=244) for chronic cough. Their data is expected to read out in Q1 2019. In a small proof of concept Phase 2 study (n=13), NeRRe’s orvepitant demonstrated a 28% reduction in cough after 8 weeks. After Menlo’s huge flop, prospects are not looking so good for NeRRe.
Today’s news further validates P2X3 candidates as the superior treatment option. Bellus (BLUSF) will be reporting Phase 1 data for their P2X3 candidate in Q4 2018 (we expect December).
Overview of Chronic Cough Landscape
Aside from the NK-1 antagonists, other drug classes currently in development are:
TRP Modulators
GlaxoSmithKline is developing a TRPV4 candidate currently in Phase 2, with data expected in mid-2019. Keep in mind, GSK’s other TRPV1 candidate did not show statistical significance in cough reduction and was considered a failure.
nAChR Modulators
Private company Attenua initiated a Phase 2 in mid-2018. In preclinical studies, Attenua’s nAChR candidate reduced cough in by about 50%.
P2X3 Antagonist
The P2X3 drug class has shown the most promise and is the most clinically validated drug class with numerous human studies. Merck’s P2X3 drug is the most advanced candidate (currently in 2 pivotal Phase 3 studies) and has shown 86% reduction in cough after 12 weeks. Merck’s drug, however, was burdened with a nasty taste side effect.
Similar to Bellus, Bayer is also developing a selective (up to 125x) P2X3 candidate that is currently in Phase 2 (data expected 1H 2019).
Bellus is developing a more selective (greater than 2000x) P2X3 candidate that we expect to show equivalent cough reduction to Merck & minimal effect on taste (read our thesis here). With positive Phase 1 data, Bellus could have the best-in-class drug and warrant a price of at least $1.25/share.
PropThink contributors are LONG BLUSF
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