Cosmo’s therapeutic focus is on the treatment of gastrointestinal diseases (including IBD, colonic infections and colorectal cancer – CRC), increase the effectiveness of endoscopic examinations and to treat persistent skin conditions, like acne, that have a long-term physical and emotional impact on lives and self-esteem.
The blend of our knowledge of the colon and the unique characteristics of the MMX® technology gives us a strong competitive edge in developing new applications for the colon without having to primarily resort to the expensive and risky pure research process for new chemical entities.
Inflammatory bowel diseases (IBD)
Inflammatory Bowel Diseases (IBD) are a group of chronic, progressive, recurring and debilitating disorders characterized by severe damage of the gastro-intestinal tract. The main forms of IBD are Ulcerative Colitis and Crohn’s Disease, but also Diverticulitis is deemed to be part of this class of diseases. These diseases are clinically similar and may be described as a faulty regulation of the mucosal immune response.
The causes of the Inflammatory Bowel Diseases are not known but it is widely believed that they could be ascribed to an auto-immune mechanism.
Inflammatory Bowel Diseases currently affects approximately 11.2%[1] of the world’s population. According to the U.S. Crohn’s and Colitis Foundation, the Ulcerative Colitis and Crohn’s Disease U.S. population size is estimated to be in excess of 3[2] million patients.
In terms of severity, gastroenterologists tend to split the patient population into three different categories (mild, moderate and severe), and prescribe medication accordingly. It is commonly believed that 45-55% of the patients have a mild form of the disease and 30-35% a moderate form. Around 30% of patients that have mild to moderate ulcerative colitis will be in the acute phase, 70% in remission.
Cosmo addresses these diseases currently with Lialda®, Uceris® and Aemcolo®.
Colonic infections
Colon infections are a group of diseases which range from short infections such as travelers’ diarrhea to hepatic encephalopathy (HE), IBS-D, clostridium difficile and chronic diverticulitis.
The most frequent colon infection is travelers’ diarrhea (TD), which primarily strikes people traveling to developing countries after ingesting food or drinks that are contaminated by bacteria. It is estimated that at least 46 million US people travel to every year to countries at medium or high risk of TD and that around 40% of these will get TD[3].
HE is caused by cirrhosis of the liver when the liver can no longer perform all its bacteria cleaning functions. The toxins can then travel to the brain and cause severe brain damage.
Clostridium difficile colitis results from a disturbance of the normal bacterial flora of the colon, colonization by C difficile, and the release of toxins that cause mucosal inflammation and damage. Antibiotic therapy is the key factor that alters the colonic flora. C difficile infection (CDI) occurs primarily in hospitalized patients.
Diverticulosis happens when pouches (diverticula) form in the walls of the colon. It is presumed that about 60% of the 60-year-old have diverticula, 70% of the 70 years old etc. It is also presumed that the peristaltic muscle structure becomes more brittle as persons age and that pressure from within the colon then causes the pouches to form. If these pouches get inflamed or infected, it is called diverticulitis. This happens in approximately 10-20% of all cases. Diverticulitis can be very painful.
Cosmo addresses these diseases with Aemcolo®.
Colorectal cancer (CRC)
CRC is the third leading cause of cancer-related deaths in men and women. Epidemiologists estimate that, at birth, every person has a 4.49% (men) 4.15% (women)[4] chance of contracting CRC during its lifetime with the disease primarily striking people that are older than 45 years.
Survival rates vary significantly depending on the stage at which CRC is diagnosed; the 5-year survival rate is 65%[5] in the USA and 56%[6] in Europe. However, since practically all CRC develop from adenomas, CRC is the only cancer that theoretically could be eradicated by developing means of detecting the adenomas as early as possible and by extracting them without major surgery.
Numerous attempts have been made at developing adenoma detection instruments, the oldest being the fecal occult blood test (FOBT). In this test the subject takes a sample of its stool, smears this on a test strip and sends the strip to a laboratory where the stool sample is analyzed for its blood content. This is then taken as a confirmation that there is a bleeding event somewhere in the colon. Since all CRCs tend to seep blood and many adenomas do so as well, the subject is then indicated for a full colonoscopy to identify and extract the cause of bleeding. FOBTs however are not very precise because the most frequent bleeding events come from hemorrhoids and because many adenomas do not bleed.
In Europe it is a standard procedure in many countries that each subject, upon its 50th birthday, gets sent a FOBT test and is urged to send in a stool sample for analysis. If this proves positive the subject is then referred to a colonoscopy. In the USA the use of FOBT tests is less frequent with subjects in the great majority opting for a direct colonoscopy.
The increased frequency of preventive measures has had a strong impact on CRC incidence. In 2000 it was estimated that by 2015 approximately 200’000 subjects would be diagnosed with colon cancer. The most recent estimates made by the US authorities now project cancer diagnoses to be down to 101’420[7] cases annually, a substantial decrease largely due to increased number of colonoscopies. In Europe it is estimated that 447’000 people are diagnosed with CRC in 2016.
In order to identify polyps, endoscopists perform colonoscopies which allow a visual inspection of the colon via endoscope. During colonoscopy, endoscopists strive to identify all polyps and remove those potentially dangerous. Removal of polyps can be challenging, especially if the polyp is flat or positioned in difficult areas.
In clinical practice, adenoma detection rate (‘ADR’) is the percentage of patients aged 50 and over undergoing a first-time screening colonoscopy who have one or more conventional adenomas detected and removed. ADR is a key quality indicator for colonoscopy; a high ADR is associated with a low post colonoscopy CRC, therefore increasing ADR is key to reducing the incidence of CRC.
Cosmo addresses these needs with Methylene Blue MMX®, Eleview® and GI Genius™.
Acne
Acne is the eighth most prevalent disease in the world, affecting more than 640 million people. Although acne often coincides with puberty affecting c. 85% of adolescents, it also impacts young adults (aged 12–25 years) and may persist into, or develop during, adulthood.
Acne is a multifactorial inflammatory condition characterised by excess skin oil (sebum) production, a build-up of dead skin cells that clog the pores and growth of bacteria that further enhance inflammation, redness and pore blockage. These events lead to acne’s characteristic lesions.
Treatment of acne usually involves combinations of oral and/or topical treatments. Antibiotic resistance in acne is a concern.
Androgen hormones are a key driver of acne in both males and females with acne. Androgen receptors (‘ARs’) are expressed throughout the skin and found in the sebum producing glands. Circulating and locally (skin)-synthesized androgens such as testosterone and dihydrotestosterone (‘DHT’) bind to the AR and stimulate sebum production in both males and females. Androgen inhibition is an effective strategy for the treatment of female acne. Certain COCs (norgestimate, norethindrone) are FDA-approved to treat acne in females; these drugs suppress androgen production, thereby reducing circulating androgens.
Cosmo addresses these needs with Winlevi® (clascoterone) cream 1%.
Androgenetic Alopecia (AGA)
Androgen induced alopecia, also known as Androgenetic Alopecia or patterned hair loss, is the most common type of hair loss affecting an estimated 50 million men and an estimated 30 million women in the U.S.
Of these, only 25-30 million men and 15-20 million women have been diagnosed, and only 2.7 million men and 2 million women or 5-10% of the total are actually being treated. A vast majority of patients have not sought treatment for their condition, likely due to the limitations of current treatments and the lack of available options. In AGA, high local concentrations of DHT bind to androgen receptors within the scalp hair follicles, resulting in shortening of the hair cycle and gradual miniaturisation of scalp follicles in men and women with a genetic predisposition. Over time, these progressively smaller, thinner hair follicles are unable to produce new hair, thus resulting in AGA’s characteristic patterned baldness. DHT-dependent effects are considered, in most cases, reversible, yet a topical treatment that can be used in both males and females with AGA remains elusive.
Cosmo addresses these needs with Breezula.
[3] Connor, Bradley A. “Travelers’ Diarrhea”, Yellow book. www.cdc.gov. June 24, 2019. Web. November 21, 2019.
[4] The American Cancer Society medical and editorial content team. “Key Statistics for Colorectal Cancer”. www.cancer.org. February 21, 2018. Web. November 21, 2019.
[5] Cancer.Net Editorial Board. “Colorectal Cancer: Statistics”. www.cancer.net. November, 2018. Web. November 21, 2019.
[6] Cancer Research UK. “Bowel cancer survival statistics”. www.cancerresearchuk.org. February 6, 2017. Web. November 21, 2019.
[7] Finlay A Macrae. “Colorectal cancer: Epidemiology, risk factors, and protective factors”. www.uptodate.com. September 20, 2019. Web. November 21, 2019.