Mr. Christopher Moreau reports

ALGERNON PHARMACEUTICALS ENGAGES MAXIM GROUP TO EXPLORE SPIN-OFF OF ITS IFENPRODIL PHASE 2 CHRONIC COUGH DRUG DEVELOPMENT PROGRAM

Algernon Pharmaceuticals Inc. has engaged Maxim Group LLC to provide financial advisory and investment banking services, and to assist in identifying and evaluating potential M&A (merger and acquisition) and strategic opportunities, including the potential spin-off of the company's NP-120 (ifenprodil) chronic cough research program.

Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B), which prevents glutamate signalling. Ifenprodil represents a novel first-in-class potential treatment for chronic cough and is thought to interfere with central signalling in the brain, suppressing the urge to cough.

"We are very pleased to be working with Maxim, and we are especially interested in the potential to achieve significant value for our ifenprodil asset, and for our shareholders, through a spin-off transaction," said Christopher J. Moreau, Algernon's chief executive officer. "Ifenprodil represents a novel first-in-class potential treatment for chronic cough, and we are only one phase 2b study away from the stage of development where Bellus's camlipixant was acquired by GSK and Afferent's gefapixant was acquired by Merck."

Algernon's phase 2a study data

The decision to advance to a phase 2b cough study was based on positive data previously reported from the company's proof-of-concept phase 2a study of idiopathic pulmonary fibrosis (IPF) and chronic cough on July 28, 2022, where ifenprodil showed a significant reduction in cough count. Patients with IPF are usually excluded from trials in refractory chronic cough (RCC), and cough in this population is regarded as extremely difficult to treat.

Further analysis revealed:

• The geometric mean 24-hour cough counts were reduced by 32 per cent at four weeks (p equals 0.023) and 39.5 per cent at 12 weeks (p equals 0.001) compared with baseline.
• The geometric mean awake cough counts were reduced by 30.2 per cent at four weeks (p equals 0.038) and 37.4 per cent at 12 weeks (p equals 0.002) compared with baseline.
• Algernon previously announced on Jan. 14, 2022, that it had received positive feedback from the United States Food and Drug Administration at its pre-IND (investigational new drug) meeting for its investigation of ifenprodil solely for the treatment of chronic cough.

Chronic cough market

According to Data Bridge Market Research analyses, the global chronic cough market was valued at $6.15-billion (U.S.) in 2021 and is projected to grow up to $11.38-billion (U.S.) by 2029.

Merck & Co. obtained the rights to gefapixant, a P2X3 receptor antagonist, as the lead asset in the acquisition of Afferent Pharmaceuticals in 2016. At the time, gefapixant had interim data from a phase 2b dose-escalation study in RCC. The deal was worth up to $1.25-billion (U.S.).

Bellus Health, which is advancing camlipixant, its own novel P2X3 receptor antagonist, announced on April 18, 2023, that GSK PLC signed a deal where they agreed to buy all the outstanding shares in Bellus for $14.75 (U.S.) per share in cash, with a total deal value estimated at $2-billion (U.S.), confirming the need for better therapies for chronic cough.

Algernon's chronic cough advisers

Dr. Jacky Smith is a professor of respiratory medicine at the University of Manchester and an honorary consultant at Manchester University NHS Foundation Trust. She runs a multidisciplinary research team whose focus is on understanding mechanisms underlying pathological cough and a regional clinical service seeing patients with refractory chronic cough. Dr. Smith is also the lead medical and scientific adviser to both Merck and Bellus Health for their RCC research programs.

Dr. Peter Dicpinigaitis is board-certified in internal medicine, pulmonary diseases and critical care medicine. He is a faculty member of the division of critical care medicine at Montefiore Medical Center, and is the founder and director of the Montefiore Cough Center, one of the few specialty centres in the world exclusively committed to the evaluation and management of patients with chronic cough.

About chronic cough

Chronic cough is defined as a cough lasting for more than eight weeks in duration and, in the United States, cough continues to be one of the most common reasons that adults consult medical doctors. Some cases of chronic cough are so debilitating that quality of life is severely impacted, leading to depression, anxiety, urinary incontinence, dysphonia, sleep interruption, vomiting and even rib fractures, further adding to the decay in socio-familial dynamics.

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 overactive to stimulus, triggering a cough at abnormal levels. Trials of cough suppressants (anti-tussives) have shown differences in response that may reflect differing pathological processes driving cough in different patients.

Experimental anti-tussives 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, like ifenprodil, where all peripheral messages are sent and co-ordinated, may achieve a better outcome than what has been achieved in clinical trials.

About NP-120 (ifenprodil)

Ifenprodil selectively inhibits N-methyl-D-aspartate receptors containing the NR2B subunit. 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.

Algernon Pharmaceuticals is a Canadian clinical-stage drug development and repurposing company investigating multiple drugs for unmet global medical needs. Algernon Pharmaceuticals has active research programs for IPF (idiopathic pulmonary fibrosis) with chronic cough and chronic kidney disease and is the parent company of a newly created private subsidiary, called Algernon NeuroScience, that is advancing a psychedelic program investigating a proprietary form of psychedelic DMT (N,N-dimethyltryptamine) for stroke and traumatic brain injury.

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