Beryl Technology is unique and innovative in five ways:

  1. Beryl Compounds are first-in-class. The naturally occurring endogenous class of lipid-signaling molecules, N acyl fatty acid amides (FAAs) constitutes a large family of structurally diverse, biologically active molecules across a range of species. Numerous FAAs have been identified in bone tissue and suggested to play a role in modulating skeletal remodeling and bone mass. With aging, remodeling leans toward negative bone balance. This is initially manifest as progression into osteopenia (OPe) and carries an increasing risk of fracture over time.
     

  2. Beryl compounds are small molecules with a unique dual mechanism of action on the bone remodeling process enables a range of utility for both sides of the remodeling equilibrium. Beryl innovation is at intersection of aging and lipidomics, an emerging field. As we age, there is a natural decrease in bone formation relative to resorption. The discovery that Oleoyl Serine (OS) is an endogenous lipid regulator of bone remodeling with a unique dual mechanism of action favoring bone formation is innovative as compared to the currently marketed products. Notably, romosozumab also has a dual mechanism of action, is a biologic and is costly ($23k/year), vis the Beryl small molecule, which is anticipated to be reasonably priced.
     

  3. Anticipated safety profile. Beryl parent compound is endogenous; has a very long history of safe, oral consumption (olive oil); with components found on the GRAS list (oleic acid and serine). Therefore, there is reason to believe that the Beryl compounds will be devoid of long-term safety risks vs alternatives (e.g., bisphosphonates, etc.), most of which require a drug holiday:

    1. Bisphosphonates: esophageal erosions, jaw necrosis; atypical femoral fractures (AFF)

    2. Teriparatide: black box warning; 2-year safety limit

    3. Denosumab: increases risk infection; jaw necrosis; AFF

    4. Raloxifene: blood clots, cannot use in boys

    5. Calcitonin: nasal spray can damage nasal passages and cause bronchospasm, swelling of tongue or throat, anaphylaxis, anaphylactic shock

    6. Abaloparatide: black box warning

    7. Romosozumab: induces an increase in cardiovascular events, including strokes
       

  4. Beryl compounds are orally bioavailable. The leading current therapeutics require injections, either administered at a doctor’s office or by daily self-injection. The Beryl compound is detectable in blood serum after oral ingestion. Because the Beryl compounds are orally bioavailable, they will most likely be easier to administer than current therapies, thereby increasing compliance.

  5. Treating osteopenia is innovative. Half of Americans over age 50 will fall into osteopenia with the potential to become osteoporotic, and there are currently no products carrying this indication. Physicians are reticent to treat osteopenia with medication because of the safety profile of current osteoporosis drugs. The cost/benefit analysis leaves many patients totally untreated or undertreated, until the severity of their disease puts them at high risk for bone breaks.​

     

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