Q - Was there not a point in time about a year ago - or maybe it was 2 years ago (covid time flies) - where Algernon was touting that their chronic cough results were better than Belus's?
A - I am unaware of any statement by the CEO stating Algernon’s data was superior to that of Bellus Health. What I am aware of is the CEO comparing Algernon to Bellus Health as it relates to their market cap versus Algernon's market cap. Bellus Health is a one-trick pony with Chronic Cough and has exceeded a market cap of 1 Billion Dollars CAD and/or USD. Thus, the message is Algernon has room to grow its Market Cap by leaps and bounds over the course of it's Chronic Cough clinical trial data. The problem to date as we all know is the stand-alone Chronic Cough study has yet to begin - targeted for Q2 2022. If any comparison is to be made between Algernon and the competition it should come in the form of Algernon 1st completing its commitment to uplist to Nasdaq. That is priority #1 over and above the start of the DMT Phase l clinical trial. Without successfully uplisting none of the information brought forth regarding clinical trial data will be reasonably valued or appreciated as the CEO stated in the news release. Uplist Uplist Uplist!
Algernon Pharmaceuticals Announces Receipt of CAD$2M Cash Refund from Australian Research Program and Files Application to List its Common Shares on Nasdaq Capital Market
“Algernon has a unique drug development business model and multiple research programs that are currently in both pre-clinical and human trials,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “Moving the Company to a U.S. national stock exchange should help improve our valuation and is expected to provide the Company with access to new investors who specialize in and understand pharmaceutical development.”
https://www.globenewswire.com/en/news-release/2021/10/21/2318193/0/en/Algernon-Pharmaceuticals-Announces-Receipt-of-CAD-2M-Cash-Refund-from-Australian-Research-Program-and-Files-Application-to-List-its-Common-Shares-on-Nasdaq-Capital-Market.html
Algernon Pharmaceuticals’ NP-120 (Ifenprodil) Outperforms Merck’s Phase 3 Drug MK-7264 (Gefapixant) in an Acute Cough Study by 110%
Ifenprodil (1.5 mg/kg) showed a reduction of 42% in mean cough frequency vs untreated control (p <0.01
Unlike Gefapixant, Ifenprodil has no known taste disturbance, which is similar to Bellus Health’s Phase 2 asset BLU-5937. Note: Bellus Health Inc. has reported that BLU-5937 had comparable efficacy to Merck’s MK-7264 (Gefapixant) in a guinea pig cough inhibition study that they conducted.
Ifenprodil, an approved NMDA Glu2B subunit inhibitor, represents a potential novel “first-in-class” treatment for both chronic cough and IPF.
https://www.globenewswire.com/news-release/2019/12/05/1956652/0/en/Algernon-Pharmaceuticals-NP-120-Ifenprodil-Outperforms-Merck-s-Phase-3-Drug-MK-7264-Gefapixant-in-an-Acute-Cough-Study-by-110.html
Merck: Gefapixant
Patients received gefapixant 45 mg twice daily, gefapixant 15 mg twice daily, or placebo. Only the higher dose was statistically significant in both studies. In COUGH-1, gefapixant 45 mg significantly reduced 24-hour cough frequency vs placebo at 12 weeks (–18.45%; 95% CI, –32.92% to –0.86%; P = .041). In COUGH-2, gefapixant showed a significant reduction at 24 weeks compared with placebo (–14.64%; 95% CI, –26.07% to –1.43%; P = .031).
La Rosa also highlighted a recently released pooled analysis of the 2 studies, which showed a reduction in objective cough frequency at week 12 for both 24-hour frequency and awake cough frequency, –18.6% and –17.4%, respectively.
https://www.ajmc.com/view/companies-provide-trial-updates-on-p2x3-blockers-for-chronic-cough
Bellus Health: BLU-5937
The SOOTHE trial, which enrolled 249 participants with a baseline awake cough frequency of ≥ 25 per hour, demonstrated a clinically meaningful and statistically significant placebo-adjusted reduction in 24-hour cough frequency of 34% at the 50 mg and 200 mg BID dose levels of BLU-5937 (p ≤ 0.005) at day 28. The 12.5 mg BID dose demonstrated a statistical trend with 21% reduction in placebo-adjusted 24-hour cough frequency (p=0.098) with a dose response observed between the 12.5 mg and 50 mg BID doses.
BLU-5937 was generally well-tolerated, with low rates of taste-related adverse events reported (≤6.5%) at all doses.
https://ir.bellushealth.com/news-releases/news-release-details/bellus-health-announces-positive-topline-results-its-phase-2b
Bayer: Eliapixant (BAY1817080)
The primary efficacy outcome was met showing a statistically significant reduction in the 24-hour cough count (average hourly cough frequency based on 24-hour sound recordings) of up to 27% for eliapixant 75 mg twice daily over placebo after 12 weeks of treatment.
Taste-related adverse events were reported in 24% of patients treated with the highest dose of eliapixant 150 mg twice daily and markedly less in patients receiving lower doses. Most were described as “a little” and “somewhat” bothersome, none described as “extremely” bothersome.
https://media.bayer.com/baynews/baynews.nsf/id/A9870EF5331EAE74C12587470023307F?open&ref=irrefndcd
European Respiratory Journal: Cough frequency in health and disease
In the total population of healthy adults the geometric mean (logsd) number of coughs per 24 h was 18.6 (0.5). Females coughed more than males (geometric mean (sd) 29.5 (0.4) versus 8.3 (0.5); mean difference 3.5-fold; 95% CI 1.9–6.8; p<0.001)
In the total population of adults with respiratory disease the geometric mean (logsd) number of coughs per 24 h detected using the automated system was 275 (0.37) (15.8-fold; 95% CI 9.7–21.9; p<0.001) greater than healthy controls. Geometric mean (logsd) cough frequency C2 and C5, and the mean±sd cough VAS and LCQ score by group are shown in table 1. Females coughed more than males (geometric mean (logsd) 381 (0.43) versus 198 (0.4)
https://erj.ersjournals.com/content/41/1/241
In my opinion:
As of right now, Bellus Health appears to have the best clinical trial results to beat with a reported 34% reduction in Cough. However, Bellus Health’s drug is limited to severe cases of Chronic Cough. Bellus Health defines a severe cough as 25 coughs or more per minute.
The European Respiratory Journal (ERJ) states those with a respiratory disease will cough as frequent as 11 coughs per hour and women in particular will cough as frequent as 16 coughs per hour. Thus, the broader market for Chronic Cough remains wide open even if Bellus Health is successful at Phase lll of the clinical trial process.
As it relates to Merck’s drug the taste tolerability remains a huge issue. It’s an issue that remains in the hands of the FDA for a market approval delayed until next March 2022:
The FDA is delaying its decision on Merck’s gefapixant by at least a few months to “provide time for a full review of the submission,” the company revealed in an SEC filing. The agency, which originally set a PDUFA date for Dec. 21, now expects to make a decision by March 21.
https://endpts.com/fda-says-it-needs-a-little-more-time-to-decide-on-mercks-p2x3-for-chronic-cough/
As of July 10, 2020
Algernon Pharmaceuticals begins screening patients for Phase 2 chronic cough and IPF study
https://www.youtube.com/watch?app=desktop&v=4yhEiskh0VM&feature=youtu.be
2 years from the video above is the approximate timeline to launch a stand-alone Chronic Cough clinical trial. Chronic Cough has the best reported preclinical trial data out of all the molecules originally in Algernon’s pipeline. Why it wasn’t a stand-alone clinical trial right out of the gate is a question that has yet to come with a coherent answer.