Fibromyalgia
Quotient expects its second product offering after FDA approval to treat fibromyalgia, one of the largest unmet markets in the biopharmaceutical industry. There are an estimated 5 million fibromyalgia sufferers in the United States and 10+ million worldwide. There have been no new FDA-approved fibromyalgia medications since 2009 and none has ever been approved in Europe.
Fibromyalgia is systemic condition that is primarily defined by complex body pain accompanied by fatigue and a range of autoimmune disorders. After thousands of patient reviews over decades there is no known single cause or identified mechanism of action. Trial results from the two major FDA approved drugs combined with recent published study results, demonstrate only modest differentials in pain reduction as compared to placebo, with a large-scale study of 3,000+ patients failing to reach statistical significance in 2017. Considering the relative significance of the high placebo response, most studies suggest only incremental pain reduction from the active pharmaceutical ingredient.
In contrast, Quotient believes the immune resetting anti-inflammatory nature of its hyperimmune IgG could dramatically improve patient quality of life. We note that IVIG is utilized to treat a systemic degeneration of the nervous system in chronic inflammatory demyelinating polyneuropathy (CIDP) as an approved indication, and it has been successful in isolated small-scale trials for treating fibromyalgia. With few existing treatments, Quotient believes its market potential in fibromyalgia is potentially equivalent to or larger than the market for rheumatoid arthritis and related conditions.
IgG in the form of IVIG is already well recognized for its ability help reset the immune system in a broad range of inflammatory/ autoimmune conditions. However, IVIG donors on average possess limited to no special immune modulation functionality; this is in stark contrast to Quotient's super donors. As a result, we expect Quotient IgG to manage a host of immunological events and reactions that occur in inflammatory/autoimmune conditions, and the potential down regulation of disease-causing autoantibodies. Further, there is clinical trials data and treatment experience that have shown the effectiveness of antibacterial antibody in treating fibromyalgia. It is important to note that Quotient's proprietary manufacturing process is designed not to damage or degrade the immune modulation effectiveness by avoiding the classic plasma fractionation denaturing agents used for plasma separation.
Conventional IVIG has already demonstrated efficacy in treating fibromyalgia and neuropathic pain and function. Due to its anti-histamine, anti-inflammatory and anti-bacterial properties, we believe Quotient's HDM IgG will significantly out-perform conventional IVIG.
Quotient expects its second product offering after FDA approval to treat fibromyalgia, one of the largest unmet markets in the biopharmaceutical industry. There are an estimated 5 million fibromyalgia sufferers in the United States and 10+ million worldwide. There have been no new FDA-approved fibromyalgia medications since 2009 and none has ever been approved in Europe.
Fibromyalgia is systemic condition that is primarily defined by complex body pain accompanied by fatigue and a range of autoimmune disorders. After thousands of patient reviews over decades there is no known single cause or identified mechanism of action. Trial results from the two major FDA approved drugs combined with recent published study results, demonstrate only modest differentials in pain reduction as compared to placebo, with a large-scale study of 3,000+ patients failing to reach statistical significance in 2017. Considering the relative significance of the high placebo response, most studies suggest only incremental pain reduction from the active pharmaceutical ingredient.
In contrast, Quotient believes the immune resetting anti-inflammatory nature of its hyperimmune IgG could dramatically improve patient quality of life. We note that IVIG is utilized to treat a systemic degeneration of the nervous system in chronic inflammatory demyelinating polyneuropathy (CIDP) as an approved indication, and it has been successful in isolated small-scale trials for treating fibromyalgia. With few existing treatments, Quotient believes its market potential in fibromyalgia is potentially equivalent to or larger than the market for rheumatoid arthritis and related conditions.
IgG in the form of IVIG is already well recognized for its ability help reset the immune system in a broad range of inflammatory/ autoimmune conditions. However, IVIG donors on average possess limited to no special immune modulation functionality; this is in stark contrast to Quotient's super donors. As a result, we expect Quotient IgG to manage a host of immunological events and reactions that occur in inflammatory/autoimmune conditions, and the potential down regulation of disease-causing autoantibodies. Further, there is clinical trials data and treatment experience that have shown the effectiveness of antibacterial antibody in treating fibromyalgia. It is important to note that Quotient's proprietary manufacturing process is designed not to damage or degrade the immune modulation effectiveness by avoiding the classic plasma fractionation denaturing agents used for plasma separation.
Conventional IVIG has already demonstrated efficacy in treating fibromyalgia and neuropathic pain and function. Due to its anti-histamine, anti-inflammatory and anti-bacterial properties, we believe Quotient's HDM IgG will significantly out-perform conventional IVIG.