Obesity Management – LPCN 2401
Obesity Management – LPCN 2401
Product Candidate: LPCN 2401
Prioritizing fat loss and lean mass preservation in healthy weight loss.
Product Attributes:
LPCN 2401 comprises a novel, liver friendly, physiological regulator of myostatin that indirectly inhibits its expression and signaling via Androgen Receptor -mediated pathways, transcriptional repression, and crosstalk with anabolic factors. LPCN 2401 is currently under development as an adjunct to Incretin Mimetics e.g. GLP-1 agonist use for quality weight loss via improved body composition or as a monotherapy post cessation of incretin mimetic use in diabesity management. Consistent with future trend of patient friendly once a day incretin mimetic LPCN 2401 is designed for once daily administration.
Data from preclinical and clinical studies support the potential of LPCN 2401 to prevent the loss lean mass and physical function associated with incretin mimetic therapies.
About Indication:
In the US, Obesity and Overweight are a Growing epidemic; ~110M adults suffer from diabetes. Approved incretin mimetics, such as GLP-1 agonists for diabetes and chronic weight management, are experiencing an unprecedented demand and usage in the US, and their use is projected to reach 30 million users by 2030.
Obesity is a chronic disease characterized by excess adiposity. Excess adiposity is associated with an increased risk of death and major comorbidities such as type 2 diabetes mellitus, hypertension, dyslipidemia, cardiovascular disease, nonalcoholic steatohepatitis, gallbladder disease, osteoarthritis of the knee, sleep apnea, and some cancers. The pathogenesis of obesity involves the interaction of genetic, environmental, and behavioral factors. Patients with overweight (i.e., those who have comorbidities indicating metabolic dysfunction) also represent a patient population at increased health risk from excess adiposity.
Weight reduction is typically defined as a long-term reduction in excess adiposity (body fat) with a goal of reduced morbidity and mortality.
The rapid weight loss observed with the approved incretin mimetics for weight management includes unwanted lean mass loss; up to 40% of the patient’s total weight loss is from lean mass that includes bone and muscle.
~24M obese elderly adults are most vulnerable to losing additional lean mass and functionality with GLP-1 agonist use.
The main drawbacks of Approved GLP-1 Receptor Agonists use is loss of lean mass. Lean mass matter because it improves metabolic health, strength and functionality and hormonal balance. Loss of lean mass has multiple negative health implications including reduced physical function, lowered basal metabolism, and increased risk of injury.
In elderly patients (≥60 years old), the equivalent of ~8 years of age-related decline in physical function was seen after just four months of incretin mimetic use. Moreover, discontinuation of incretin mimetic therapies frequently results in a rapid regain in weight, potentially mostly as fat mass.
Furthermore, 2 out of 3 people on GLP-1 drugs (like Ozempic or Wegovy) stop within a year1 emphasizing need for a convenient noninvasive option with improved tolerability.
There is a significant unmet need, as an adjunct to glp-1 use, for an oral, efficacious treatment option to enable healthy chronic weight management through improved body composition that predominantly reduce fat mass while preserving lean mass to reduce fracture risk and maintain functionality. Moreover, there is a need for a chronic pharmacotherapy option to maintain weight and newly acquired diabetes remission, prevent fat rebound, and improve lean mass upon cessation of incretin mimetic therapy.