The Autoimmune Landscape
Type 1 Diabetes
Current type 1 diabetes solutions manage the disease rather than curing it.
Phaim’s Antigenic Immune Modulation (AIM) platform is designed to change this, by curing, improving, halting or preventing the disease all together.
What is Type 1 Diabetes?
Type 1 diabetes is a chronic and life-altering form of diabetes mellitus that is caused by the autoimmune destruction of insulin-producing beta cells in the pancreas. After a gradual decline, this can lead to a complete stop in the body’s natural insulin production. The development of type 1 diabetes is still not fully understood, but is known to be influenced by a combination of factors, including genetics, the environment, and exposure to certain immune triggers.
Traditional Standard of Care
Typically, patients with type 1 diabetes must regularly test their blood glucose levels and manage them by injecting insulin. Patients may also rely on lifestyle advice to manage the condition. However, these methods can lead to co-morbidities, which place a burden on both patients and healthcare systems.
The type 1 diabetes market size has grown to $8 billion and is dominated by insulin treatments.
Recent Type 1 Diabetes Developments
Continuous blood glucose monitoring has become increasingly common with the use of digital solutions or insulin pumps. Patients may also choose to manage their blood glucose level through an ‘artificial pancreas’, as shown in the image.
Immunotherapy treatments have been explored but often rely on suppressing the immune system, which can lead to dangerous side effects, such as increased susceptibility to diseases like cancer and a loss of normal immune function.
There is an unmet need for therapeutics that address the disease at its source rather than managing signs and symptoms.
Why Phaim is different
We break reliance on immunosuppressants.
Phaim’s AIM therapy is antigen specific and can therefore target the disease directly, reducing the need for immunosuppressants that shut down the immune system and lead to dangerous side effects. Previous large-scale approaches to immune modulation have lacked this specificity, reducing efficacy.
We identify the disease relevant antigens using a unique methodology.
Phaim fragments the protein related to the autoimmune disease, creating a unique “soup” of antigenic epitopes which is formulated into the drug. Previous scientific attempts have showed limited efficacy.
We enable an easy delivery method.
Phaim administers therapy via depot injection, which provides an optimal immune response and greater clinical efficacy compared to previous approaches, such as subcutaneous and oral administration.
We use a unique adjuvant.
Phaim’s unique adjuvant provides the optimal immune response. Animal data has shown this specific adjuvant, unlike adjuvants others have used, causes immune cells to swarm and react efficiently to the therapy’s components.
We have extensive global regulatory experience.
Phaim’s team has decades of proven experience in seamless drug development, conducting clinical studies at FDA, TGA, MHRA level.
We have achieved excellent cGMP standards.
Phaim’s novel drug platform has completed CMC manufacturing methods with excellent stability, toxicology and scalability profiles.
We offer diagnosis in addition to therapy
Phaim is developing a novel companion biomarker to identify patients at risk of autoimmune diseases, broadening the pool of potential AIM patients. Other diagnosis methodologies measure antibodies and are non-patient specific. Read more about this here.
How does Phaim’s AIM platform work?
Other Autoimmune Disease Opportunities for Phaim’s AIM Platform
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Psoriasis is a chronic autoimmune disease primarily affecting the skin and often joints. The worldwide prevalence is estimated at 2-3%, approximately 125 million people (2015). The overall incidence of psoriasis is also high and increasing over time. Psoriasis commonly develops between the ages of 15 and 35, but it can develop at any age, even in infants. About 10-15% of those with psoriasis get it before 10 years of age.
There is no cure for psoriasis.
Current treatments are aimed at reducing inflammation in order to clear the skin. Topical medication (creams, ointments), light therapy (UV light, A or B) and systemic drugs are used to provide some relief. Systemic drugs are immunosuppressive agents (Methotrexate, Cyclosporine) with significant potential side-effects. More recently drugs called biologics have been used.
Phaim's Antigenic Immune Modulation therapy is a potential game changer and a curative approach to psoriasis.
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Rheumatoid Arthritis (RA) is an autoimmune disease. Approximately 60% of the risk of developing RA is accounted for by genetic predisposition. As in other autoimmune diseases there are triggers, such as environmental factors which ultimately initiate the destruction primarily of the joints. In genetically predisposed, at-risk subjects environmental stressors trigger changes in self antigens in the mucosal layer in the joints. This in turn evokes a pathological immune response both cellular and humoral. Often it takes years before it manifests as clinical disease. Over time the inflammation localised at the joint synovia destroys the cartilage and damages the bone. Quality of life is severely reduced. It is important to note that RA does not exclusively involve the joints. Premature deaths are often linked to RA-associated interstitial lung disease and cardiovascular failure.
This once severely debilitating disorder is now more manageable, but no curative treatment is available.
Treatment regimens are cumbersome and have limited effectiveness. Disease-modifying antirheumatic drugs (DMARDs) are a combination of several immunosuppressive medications (Methotrexate, Sulfasalazine, Azathioprine) often combined with anti-inflammatory agents such as steroids. Even with aggressive DMARD regimes started early in the disease process, remission is achieved in less than 25% of cases.
There is a clear need for a radical novel approach. A new therapeutic modality to arrest the autoimmune destruction.
Our Antigenic Immune Modulatory (AIM) platform has great potential to succeed across differing autoimmune diseases, including RA.
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Multiple Sclerosis (MS) is a progressive, debilitating, lifelong autoimmune disease of the central nervous system. It can start at any age, however most commonly in people in their thirties. It is estimated that 2.3 million (2013) people live with MS worldwide. In the US 400,000 (2016) and in Europe approximately 700,000 (2017) people are diagnosed with the disease. In the UK alone, the number of cases is estimated to be 130,000 (2017). The MS incidence has increased dramatically (~10%, 2016) in the last decade which may be partially due to better diagnostics.
Medical and non-medical costs, fitness to work and quality of life are all negatively affected by increasing severity of the disease. Diagnosis is lifelong and most commonly starts relative early in life, thus the direct and indirect costs are staggering. In Europe the average yearly cost of all resources relating to MS was €22,800 for those patients with mild disease severity, €37,100 for those with moderate disease severity, and €57,500 for those patients with severe disease (2017). Fitness to work is reduced dramatically as the disease progresses: 18% are out of work with mild MS but a staggering 92% with severe MS (2017). In the US the annual cost (direct and indirect i.e. lost wages) is approximately $69,000 of which approximately $39,000 consists of health care costs. The total annual cost for all people with MS in the US is approximately $28 billion (2006). In the UK the economic impact is substantial too. It is estimated at £1.4 billion annually.
Disease Modifying Therapies (DMTs) in MS are immunosuppressive agents with serious potential side-effects. These drugs are very expensive and, although they can reduce relapses, they cannot stop the progression of the disease.
Clearly there is an urgent need for novel therapeutic approaches addressing the relentless progressive nature of the disease but without immune suppression. Our Antigenic Immune Modulation (AIM) platform is uniquely suited to address these challenges and produce a market-disruptive alternative with a potentially curative therapy.