Sarcopenia - Pipeline Insight, 2024

This “Sarcopenia- Pipeline Insight, 2024” report provides comprehensive insights about 8+ companies and 10+ pipeline drugs in Sarcopenia pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Sarcopenia: Understanding

Sarcopenia: Overview

Sarcopenia is a musculoskeletal disease in which muscle mass, strength, and performance are significantly compromised with age. Sarcopenia most commonly affects elderly and sedentary populations and patients who have comorbidities that affect the musculoskeletal system or impair physical activity. Such musculoskeletal degeneration may impede daily activities and demonstrates predictive value regarding unfavorable postoperative outcomes, and increased complication rates, mortality, and morbidity in major surgical procedures. Additionally, sarcopenia is strongly associated with a greater incidence of falls and increased fracture risk. Furthermore, decreased muscle mass or muscle function, both criteria for sarcopenia, are risk factors for loss of independence in patients over the age of 90 years old.

Generally, a significant decline of type II, but not type I muscle fibers are observed in sarcopenic patients. Several mechanisms of the underlying pathophysiology of sarcopenia have been described: i) Age-related declines in anabolic hormone serum concentrations: Normal physiological serum levels of anabolic hormones such as testosterone, human growth hormone (HGH), and insulin-like growth factor-1 (IGF-1) have been demonstrated to function in the development, maintenance, or rejuvenation of muscle tissue. Age-related declines of such hormones are observed in patients with sarcopenia and thus, support this underlying pathophysiology of the disease. ii) Insulin resistance with “sarcopenic obesity”: Aging patients often experience changes in body composition represented by increased adipose tissue alongside decreased muscle mass, coined as “sarcopenic obesity.” These changes are associated with metabolic dysfunction, including insulin resistance (IR), leading to the accumulation of visceral fat mass. Iii) Age-related neurodegeneration: Progressive neurodegeneration is a commonly observed phenomenon in aging populations. Aging is accompanied by a decline of alpha motor neurons in the spinal cord, loss of peripheral nerve fibers, and reduced number of neuromuscular junctions. Considering the role of the neurological system in muscle fiber recruitment, current evidence supports neurodegeneration as underlying pathophysiology for reduced muscle strength and size in sarcopenia. iv) Age-related increase in inflammatory markers: Elevated levels of C-reactive protein (CRP), tumor necrosis factor-alpha (TNF), interleukin (IL)-6, and IL-1 are observed in elderly populations. The catabolic effects that may be exerted by these cytokines on skeletal muscle are well documented and may present a mechanism in which sarcopenia develops with age.

Recent clinical trials on sarcopenia therapies such as physical exercise, nutraceutical, and pharmaceutical interventions have revealed that exercise is the only effective strategy shown to alleviate sarcopenia. Unlike nutraceutical and pharmaceutical interventions that showed controversial results in sarcopenia alleviation, exercise was found to restore mitochondria homeostasis and dampen inflammatory responses via a complex exchange of myokines and osteokines signalling between muscle and bone. However, as exercise have limited benefit to immobile patients, the use of stem cells and their secretome are being suggested to be novel therapeutics that can be catered to a larger patient population owing to their mitochondria restoration effects and immune modulatory abilities. Nonetheless, prevention, management, and treatment of sarcopenia are most effectively achieved by maintaining physical activity and increased protein intake. Specifically, patients should be educated on the daily and per meal basis protein recommendations.

Sarcopenia- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Sarcopenia pipeline landscape is provided which includes the disease overview and Sarcopenia treatment guidelines. The assessment part of the report embraces, in depth Sarcopenia commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Sarcopenia collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Sarcopenia R&D. The therapies under development are focused on novel approaches to treat/improve Sarcopenia.

Sarcopenia Emerging Drugs Chapters

This segment of the Sarcopenia report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Sarcopenia Emerging Drugs

BIO101: Biophytis Sarconeos (BIO101) is a small molecule proto-oncogene protein c-mas-1 agonist that is administered orally. Based on results from cellular and animal studies, it is believed that Sarconeos (BIO101) stimulates biological resilience through activation of the MAS receptor and may have the potential to improve muscle function and preserve strength, mobility, and respiratory capacity in various age-related and muscular wasting conditions. The drug showed a very good safety profile at the doses of 175 mg bid and of 350 mg bid with no Serious Adverse Events (AE) related to the product in the Phase II clinical trial study. Biophytis is now committed to progressing Sarconeos (BIO101) into Phase III either alone or through partnerships with pharmaceuticalcompanies.

MYMD-1: My MD Pharmaceuticals Originally developed for autoimmune diseases, MYMD-1’s primary purpose is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. MYMD-1 is also showing promise in pre-clinical studies as a potential treatment for post- COVID-19 complications and as an anti-fibrotic and anti-proliferation therapeutic. In January 2022, MyMD Pharma announced that he U.S. Patent and Trademark Office (USPTO) awarded to the company U.S. Patent 11,219,620 B2, titled “Method of Treating Sarcopenia.” The patent was issued on January 11, 2022. Currently it is being evaluated in Phase II clinical studies to treat patients withSarcopenia.

Sarcopenia: Therapeutic Assessment

This segment of the report provides insights about the different Sarcopenia drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Sarcopenia

• There are approx. 8+ key companies which are developing the therapies for Sarcopenia. The companies which have their Sarcopenia drug candidates in the most advanced stage, i.e. phase II include, Biophytis.

Phases

This report covers around 10+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Sarcopenia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Sarcopenia: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Sarcopenia therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Sarcopenia drugs.

Sarcopenia Report Insights

• Sarcopenia Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Sarcopenia Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Sarcopenia drugs?
• How many Sarcopenia drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Sarcopenia?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Sarcopenia therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Sarcopenia and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Biophytis
• My MDPharmaceuticals
• Turn Biotechnologies
• Oncocross
• NMD Pharma

Key Products

• BIO101
• MYMD-1
• OC514
• NMDP 05
• TRN 005

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