A closer look at the topline data from a 12-week, Stage 2a proof of concept study that used NP-120 (“Ifenprodil”) to treat idiopathic pulmonary fibrosis (IPF) and chronic cough, proves that sometimes you do get a second chance to make a first impression.
Vancouver-based Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGN0:XFRA), a clinical-stage pharmaceutical development company, says that upon further review, Ifenprodil was shown to be much more effective at reducing cough in patients than the company had originally reported.
Dr. Jacky Smith, Algernon’s primary scientific advisor and a global expert on cough, was largely absent for the first look at the topline data due to illness. But once she was able to conduct a more rigorous examination of the data, she concluded that there had been a significant improvement in mean objective 24-hour and waking cough counts after 4 and 12 weeks.
In a July 18, 2022 note, Research Capital Corp. Healthcare Analyst Andre Uddin gave Algernon a Speculative Buy rating and CA$25 target price, which values the company at roughly CA$50 million.
Indeed. Smith’s analysis showed that the geometric mean 24-hour cough counts were lowered by 32% at 4 weeks and 39.5% at 12 weeks, versus the baseline.
Meanwhile, the geometric mean awake cough counts were reduced by 30.2% at 4 weeks and 37.4% at 12 weeks, when compared with the baseline (the company says geometric mean is often used as a statistical analysis method employed in trials measuring objective cough counts to better account for significant variations in the data values).
“This additional analysis confirms my initial positive impression of the study,” said Dr. Jacky Smith, Professor of Respiratory Medicine at the University of Manchester in the U.K.
She added: “To see effects of this magnitude in an IPF population, where other drugs have failed to demonstrate a benefit, is notable, and I look forward to seeing the company’s full data set.”
Research Capital Corp. Healthcare Analyst André Uddin wrote in a July 28 note that Smith's opinion should be seen with some gravitas.
Uddin wrote: "Dr. Jacky Smith is an expert in chronic cough. As an example, Dr. Smith has been instrumental in helping Bellus Health Inc. advance their chronic cough candidate — hence her opinion on Algernon's cough candidate should not be taken lightly.”
The full data set will likely be published before the end of August.
In addition to lower cough counts, the Stage 2a study demonstrated that 13 out of 20 IPF patients (65%) who enrolled in the study had stable or better lung capacity after 12 weeks.
Cough in IPF patients has been historically even more difficult to treat than stand-alone chronic cough.
The Phase 2 study’s positive topline data brought Algernon even closer to adding a new IPF and cough treatment to the market.
But Algernon must decide if it’s going to target the US$1 billion chronic cough market or the US$4 billion IPF market, which market research firm Imarc says is growing at a compound annual rate of 7.2% (and that’s without a full understanding of the impact of COVID-19), which is not a bad problem to have.
Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist that prevents glutamate signalling and represents a novel first in class treatment for both IPF and chronic cough.
Because IPF is an orphan disease indication (that means less than 200,000 people suffer from it), if the drug ends up being approved in the U.S. it will receive 7 years of exclusivity. That number jumps to 10 years in Europe.
Uddin gives Algernon a Speculative Buy rating and CA$25 target price, which values the company at roughly CA$50 million. Meanwhile, on July 28 Technical Analyst Clive Maund gave the company a Strong Buy recommendation.
The company has just 1.979 million shares outstanding. Its largest investor is Toronto-based AlphaNorth Asset Management, which owns about a 7% stake.
Algernon trades in a 52-week range of CA$13 and CA$3. It closed at CA$3.20 on July 27.
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