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Alzheimer’s: A New Direction for Algernon
Algernon Pharmaceuticals is entering the Alzheimer’s Disease (AD) diagnostic market segment with plans to establish a network of dedicated neuroimaging medical clinics in North America, utilizing the most advanced, FDA cleared brain-specific PET scanner to focus on the early stage detection of the disease. This initiative expands on the Company’s current neurological research programming.
AD is a chronic neurodegenerative disease that destroys brain cells, resulting in the steady decline over years of a person’s thinking ability, and memory. The most common cause of dementia, AD begins with the appearance of a buildup of proteins in the brain in the form of amyloid plaques and neurofibrillary tangles, the key defining features of the presence of the disease.
It is estimated that nearly 7 million Americans and 750,000 Canadians are living with AD. By the year 2050, these numbers are projected to rise to 13 million and 1.7 million, respectively. AD remains the fifth leading cause of death among people 65 years of age and older and the number of individuals developing early AD has recently tripled among those 30 to 64 years of age.
The new clinics will be the first dedicated neuroimaging facilities of their kind in North America utilizing the CareMiBrain™ brain-specific, Positron Emission Tomography (PET) scanner system. The clinics – to be initially established in the U.S. - will be focussed on the early-stage detection of Alzheimer’s Disease, and will also provide PET scans for other forms of dementia, epilepsy, neuro-oncology, and movement disorders.
In recent findings, the Alzheimer’s Association reports that nearly 80% of Americans surveyed would want to know if they had Alzheimer’s disease before having symptoms, or before those symptoms interfered with their activities.
Algernon will be working in partnership with neurologists, geriatricians, personal care physicians, and other medical professionals and organizations, to build awareness and generate patient referrals for the clinics.
Algernon has established an agreement with Catalyst MedTech for the supply of CareMiBrain™ scanners, as well as consulting on clinical solutions including radioactive materials application consultation, guidance on policies, procedures, license and permit application drafting, submission assistance, and regulatory response.
Catalyst MedTech is the leading U.S. provider of molecular imaging and nuclear medicine technology to physician practices and healthcare systems and has over 500 employees. Catalyst recently secured the exclusive distribution rights for the Oncovision CareMiBrain™ PET scanning system in the U.S., has ISO 9001:2015 and ISO 13485:2016 designations, and is certified in the sales, repair, refurbishment, installation, and servicing of medical imaging devices serving clients across the U.S.
Catalyst will also provide guidance to Algernon on accreditation, compliance, payer conflict resolution, renewal obligations and all aspects of billing & coding for the clinics. The agreement also includes a warranty and services contract for each PET scanner, also to be provided by Catalyst MedTech.
Recent Developments and FDA Approvals
Algernon is moving into this space because there have been some major developments in the AD healthcare segment recently in the U.S.
The FDA approved two new AD antibody treatment therapies developed by Eli Lilly (Kinsula) and Eisai and Biogen (Leqembi) - which are covered by U.S. Medicare and Medicaid, as well as by private insurance - that for the first time can clear amyloid plaque from the brain and help slow down the progression of the disease.
The FDA has also approved the new ultracompact Oncovision CareMiBrain™ brain-specific, Positron Emission Tomography (PET) scanner system which can confirm amyloid plaque buildup, a prerequisite established by the FDA prior to the administration of the new AD drugs. Confirmation can also be provided through a spinal tap, which is a highly invasive procedure that Algernon believes patients would not opt for if they had ready access to a painless, non-invasive PET brain scanner at a clinic in their communities.
PET brain scans to confirm the presence of amyloid plaque are also covered by U.S. Medicare and Medicaid, and by private insurance, for individuals 65 years and older.
The new CareMiBrain™ PET scanner - which is incorporated into a comfortable, dental-styled, clinical chair that can perform the same brain scanning functions of traditional PET scanners in hospitals - will be featured in Algernon’s neuroimaging clinics to perform high-resolution brain PET imaging with radiotracers indicated for detecting/confirming amyloid plaques and related biomarkers associated with AD, as a prelude to drug therapy administration.
Prior to the recent development of having approved AD therapies available, there has not been any urgent clinical need to provide widespread genetic screening to patients or to conduct the now available blood tests that correlate with the presence of plaque in the brain.
This paradigm has now shifted and Algernon plans to make a major contribution in the provision of AD healthcare in what has historically been a dramatically under resourced area of medicine through the establishment of its new medical clinics.
In addition, Algernon will also be targeting what may be an even broader market, namely, the early-stage detection of Alzheimer’s in individuals over 40 years of age.
Studies show that pathological changes such as amyloid-beta plaque and tau protein accumulation (also associated with the advance of AD), can occur 20 years before any noticeable cognitive symptoms arise, underscoring the tremendous importance of early detection, lifestyle change and risk management, timely monitoring of progression, and possible pharmacological treatments/intervention.
While the establishment of the neuroimaging clinics represents a new business channel for Algernon intended to deliver near term cash flow and enhance valuation, the Company will continue to maintain and advance its current drug development research programs, including its active companion work on restoring brain function following stroke and traumatic brain injury through its subsidiary Algernon NeuroScience.
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