BioRestorative Therapies Enters Preclinical Assessment Of Its Patented Stem-Cell Technology Prior To First-In-Human Studies

Clinical-stage biotech innovator BioRestorative Therapies BRTX recently announced that it is entering a new program of preclinical metabolic testing for its patented stem cell biology technology, ThermoStem®.

BioRestorative, which went public in November 2021, is currently engaged in the development of treatments for disc/spine disease and metabolic disorders. In May, the company announced that it would begin a new preclinical metabolic program focused on the treatment of obesity.

Preclinical metabolic programs are detailed studies that examine the safety and efficacy of treatments and are conducted prior to the start of first-in-human (FIH) studies. The company sees significant opportunities for ThermoStem® to help treat the worldwide obesity epidemic.

Morgan Stanley Research estimates that the global market for obesity drugs will be greater than $100 billion by 2030.

"We believe that our proprietary ThermoStem® technology platform has immense potential to develop both best-in-class and first-in-class therapies to treat metabolic disorders such as obesity," said Lance Alstodt, BioRestorative's Chief Executive Officer, when announcing the commencement of the new program.

How ThermoStem® May Be Used To Treat Obesity

Brown adipose tissue (BAT) is a type of body fat that regulates temperature. Our bodies use it to convert food energy into heat. As such, BAT is also a primary target in obesity prevention strategies.

Initial preclinical research indicates that increased amounts of brown adipose in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown adipose may have a reduced risk for obesity and diabetes.

BioRestorative's preclinical metabolic program is the first step in developing cell-based therapy candidates to target obesity and metabolic disorders. These therapies would use BAT derived from stem cells to mimic the naturally occurring fat that regulates metabolic homeostasis in humans.

The ThermoStem® technology platform may be able to play a role in adipose metabolism by transporting proteins and the molecules that transcribe and translate the cellular processes that impact weight loss.

Alstodt says that there is a significant unmet need for the types of follow-on treatments that BioRestorative's new therapeutic candidate can deliver to current weight loss drugs, such as Ozempic from Novo Nordisk NVO or Mounjaro from Eli Lilly LLY. Targeting obesity through an exosome-based biologic is a novel approach.

The Emerging Role Of Exosomes As Novel Obesity Therapeutics

Exosomes are nanoscale membrane vesicles used by the body to transport and transfer genetic material. They are exceptionally adept at targeting and modifying the biological activities of specific cells or tissues.

Extracellular vesicles like exosomes are critical to intercellular communications. They help our bodies maintain homeostasis. Because they transfer biological messages from a donor cell to a recipient cell, exosomes present a novel platform for delivering therapeutic materials to a targeted cell or tissue.

BioRestorative's Alstodt says that this may allow for lower dosing and it could help prevent or minimize the potential for muscle mass loss and negative cardiovascular effects. As such, the ThermoStem® technology platform could help develop best-in-class and first-in-class therapies to treat obesity.

Preclinical data from a study conducted in collaboration with the University of Utah School of Medicine demonstrated that functional BAT derived from stem cells, formulated using BioRestorative's proprietary ThermoStem® platform, produced significant reductions in weight and blood glucose levels.

More About BioRestorative Therapies: Company Brief

BioRestorative Therapies develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. It owns a broad intellectual property portfolio that can be leveraged across other companies' currently approved and marketed drugs to potentially create partnership opportunities with large pharmaceutical manufacturers.

BioRestorative's flagship cell therapy candidate is formulated from one’s own stem cells that can be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to surgical procedures. It also has a proprietary biologic serum specifically engineered to reduce the appearance of fine lines and wrinkles and to bring forth other areas of cosmetic effectiveness.

The company expects to file a new drug master file (DMF) submission to the U.S. FDA for the treatment of obesity in the third quarter and to begin human trials before the end of 2024.

Featured photo by Vika_Glitter on Pixabay.

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