“I am very pleased Algernon has decided to conduct a stand-alone, Phase 2b study for cough,” said Dr.
In addition to being Algernon’s lead chronic cough advisor,
The decision to advance the study is based on positive data previously reported on
The analysis showed that:
- The geometric mean 24-hour cough counts were reduced by 32.0% at 4 weeks (p = 0.023) and 39.5% at 12 weeks (p = 0.001) compared to baseline
- The geometric mean awake cough counts were reduced by 30.2% at 4 weeks (p = 0.038) and 37.4% at 12 weeks (p = 0.002) compared to baseline
Algernon previously announced on
While the Company originally planned to focus on IPF in a Phase 2b study, Algernon has now decided to pursue a chronic cough study first, and to delay planning its IPF Phase 2b study for Ifenprodil until a later date.
Study Design
The planned study design will include the following elements:
- Multinational, three-arm, randomized, double-blind, placebo-controlled trial to evaluate NP-120 in approximately 180 patients.
- Patients will be randomized 1:1:1 to receive NP-120 (20mg TID) or NP-120 (40mg TID), or placebo for 12 weeks.
- The primary endpoint will be the reduction in geometric mean 24-hr cough count over 12 weeks compared to placebo.
- Secondary endpoints will include safety, tolerability and patient-reported quality-of-life measures.
"The design of Phase 2 studies in chronic cough have been validated in trials conducted by Merck & Co and
Chronic Cough Market
According to
Merck & Co. obtained the rights to Gefapixant, a P2X3 receptor antagonist, as the lead asset in the acquisition of
Bellus Health which is advancing its own novel P2X3 receptor antagonist, BLU-5937, has a market cap of over USD
About Chronic Cough
Chronic cough is defined as a cough lasting for more than eight weeks in duration and in
Chronic cough is believed to be the result of a hypersensitivity of the cough reflex within the neuronal circuitry that governs the urge to cough, wherein one or more aspects that regulate cough are over-active to stimulus, triggering a cough at abnormal levels. Trials of cough suppressants (Antitussives) have shown differences in response that may reflect differing pathological processes driving cough in different patients. Experimental Antitussives often only engage a single receptor, while the overall cough response is governed by multiple receptors triggered by a large variety of stimuli. A compound acting centrally where all peripheral messages are sent and coordinated may achieve a better outcome than what has been achieved in clinical trials.
About NP-120 (Ifenprodil)
Ifenprodil selectively inhibits N-methyl-D-aspartate (NMDA) receptors containing the NR2B subunit. NMDA receptors are ion-channels found within the central and peripheral nervous system, including the area of the brain responsible for coordinating the cough reflex. They are highly implicated in events such as neuronal plasticity (strengthening of neural pathways) and excitotoxicity (neurotoxic cascade resulting in neuron death).
By inhibiting NMDA receptors, Ifenprodil can diminish excitability of neurons and prevent the relaying of information along neuronal circuitry, including the cough reflex. Ifenprodil may also inhibit the neuroplastic enhancement of central and peripheral cough response neurons.
About Algernon Pharmaceuticals Inc.
CONTACT INFORMATION
CEO
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com.
Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.
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