GLPG-0492

Sarcopenia is the loss of muscle mass and muscle strength as a person reaches age thirty or more, in response to aging, affecting the level of activity and quality of life. It has been identified in three stages in older people: presarcopenia-loss of muscle mass, sarcopenia-loss of muscle which can affect either physical performance or physical strength, and severe sarcopenia-loss of muscle mass that affects both physical performance and strength. According to The Sports Journal, it has been found that approximately 0.5% to 1.0% muscle mass is lost every year after the age of 70. This loss of muscle mass is reported as 4.7% decrease in men and 3.7% decrease in women per decade. This loss of muscle mass leads to decrease in muscle function with increased chances of functional impairment, disability, and mortality in the elderly. In the year 2000, the cost attributed to sarcopenia was 1.5% of the total healthcare expenditure. It was estimated that 10% reduction in the occurrence of sarcopenia could save US$ 1.1 billion worth healthcare expenditure. Identification of sarcopenia can be done through numerous techniques to measure muscle mass, involving chemical composition, imaging (computed tomography [CT], magnetic resonance imaging [MRI] and dual-energy x-ray absorptiometry [DXA]), anthropometry or hydrostatic weighing. Amongst these, DXA is the most preferred technique. Read Report Overview - To overcome the symptoms of sarcopenia, an individual has to routinely do weight lifting and strength building exercises. Progressive Resistance Training (PRT) is the most suitable exercise in this condition and it should be performed as the primary action for the treatment of sarcopenia. The sarcopenia treatment market is forecasted to grow in the future as a result of increasing rate of obesity throughout the world as obesity disturbs the metabolic function of the body. According to NIH, almost 3 of 4 people are deemed to be obese. The prevalence of obesity is similar in men and women (about 36 percent). Currently, sarcopenia treatment comprises only off label and generic drugs like estrogen, progesterone, and some growth hormones. There are no promising drugs in the pipeline for the treatment of sarcopenia. Therefore, the global sarcopenia treatment market is forecasted to see sluggish growth due to unavailability of new drugs in the near future. Despite low market assessment, pharmaceutical companies such as GSK and Five Prime Therapeutics have signed a collaboration agreement to develop therapies for sarcopenia. They are focused on developing a new class of drugs called SARMs (selective androgen receptor modulators) to prevent and treat muscle wasting or muscle loss conditions like chronic sarcopenia and cancer. Request Brochure of Report - Increased aging and obesity are the driving factors responsible for the growth of the sarcopenia treatment market. Furthermore, lack of a permanent cure for the treatment of sarcopenia, increased R & D development through government policies, changes in disease management etc. are factors anticipated to drive the growth of the sarcopenia treatment market. Request for Analysis of COVID-19 Impact on Sarcopenia Treatment Market- Geographically, the sarcopenia treatment market is segmented into North America, Latin America, Europe, and Asia Pacific (excluding Japan), and the Middle East & Africa. North America followed by Europe has the largest market share owing to the availability and affordability of expensive tests and therapies in this region. Rising population, increased research activities, and awareness in developing countries such as India and China are the factors contributing to the growth of the sarcopenia treatment market in Asia. Pre Book Sarcopenia Treatment Market Report - The major players in the global sarcopenia treatment market are GlaxoSmithKline, Radius Health, Inc. and Five Prime Therapeutics, Inc. who are involved in the development of SARMs (selective androgen receptor modulators) class of drugs. More Trending Reports by Transparency Market Research: Diagnostic Specialty Enzymes Market Enzymes are natural biocatalysts, produced and harvested from living organisms such as plants, animals, bacteria, and fungi. Diagnostic specialty enzymes are used in low volume and high value-added applications. Applications of diagnostic specialty enzymes include clinical chemistry, molecular diagnostics, and immunoassay. Corporate Wellness Market The demand within the global corporate wellness market is growing on account of advancements in the domain of employee welfare. The corporate sector has come under the radar of scrutiny, and is being closely monitored for its employee welfare policies. 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Dosing and Enrollment in HT-100 Trial Suspended: Updated February 4 Dosing and new patient enrollment in all cohorts of the HALO trial, a study evaluating the compound HT-100 in patients with Duchenne muscular dystrophy, a rare disease that results in muscle degeneration and premature death, are being suspended. We are saddened to report that one of the patients in the trial, receiving 60μg/kg/d (the highest dose in the study), is experiencing serious, life-threatening health issues, and the company is working with the FDA to analyze the situation. We do not yet know to what extent the patient’s health issues are related to HT-100 and/or to other factors. Updated February 4: It is with great sorrow that we share that the brave young man who was experiencing serious, life-threatening health issues has passed away. We offer our deepest condolences to his family and loved ones. Akashi has initiated a comprehensive investigation, beginning with detailed data reviews and in vitro studies, to evaluate the extent to which the patient’s health issues are related to HT-100 and/or to other factors. We will share updates as we reach conclusions in the investigation. What steps is Akashi taking to analyze the situation? Updated February 4: Akashi has initiated a comprehensive investigation, which includes a careful review of all patient records, with a particular focus on this young man’s record, and is initiating the first in a series of studies to further analyze what happened. Experts from outside the company are helping Akashi’s scientists and clinicians in these efforts. We continue to work with the FDA, and based on what we find, our research program will determine additional protective measures, if any, that should be included in the HT-100 program. Have health issues of this kind previously been reported in the HALO trial? None of the other patients in the clinical program have experienced a health issue of this kind or of this severity. To date, patients in the three lower-dose cohorts have been treated for between 11 and 19 months with HT-100, amounting to more than 20 patient-years of favorable data, with no other serious events related to study drug, while this patient had been receiving HT-100 at higher doses for approximately two weeks. An interim safety and efficacy analysis of HALO released in June of 2015 showed promising results for boys and young men enrolled in the HT-100 trial at lower doses, including data supporting improvement in muscle strength, with no serious adverse events related to the study drug. Why has Akashi suspended the trial? The trial has been suspended, based on discussions with the FDA, to allow us time to better understand the circumstances that led to this patient’s experiences. We will continue discussions with the FDA and will provide information once the investigation is complete. Our earlier-stage clinical and preclinical programs in Duchenne muscular dystrophy, with experimental compounds DT-200 and AT-300, are not affected. When will the trial be restarted? Our intention is to restart the trial once our investigation into the causes of this patient’s experiences is complete, and Akashi and the FDA are satisfied that any measures that might be necessary can be put in place to address these causes. As we are at the very beginning of the investigation, we cannot provide a projected timeline. As always, our first priority is patient safety. What should patients enrolled in the trial, or planning to enroll in the trial, know? If families of patients participating or planning to participate in the HT-100 trial have any questions, they may contact Akashi at trialinfo@akashirx.com or the principal investigator at their clinical site.