Our Lead Program is in PCOS
Based on strong preclinical evidence, the human clinical experience and identification of indications with high unmet medical needs; the company intends to advance its lead compound, AMTX-036, for the treatment of polycystic ovarian syndrome (PCOS). PCOS is a heterogeneous disorder affecting 5-15% of pre-menopausal women. PCOS is characterized by hyperandrogenism, ovulatory dysfunction and cystic ovaries. Elevated testosterone in PCOS leads to the loss of estrous cyclicity and infertility, as well as symptoms of hirsutism and acne. More than half of the patients suffer from insulin resistance, diabetes, and obesity. The increased circulating insulin further exacerbates hyperandrogenism by having a direct effect on ovarian theca cells, creating a cycle feedback loop between the endocrine and metabolic systems.
The company believes that activation of TAS2R1 in the small intestine, adipose tissue, and ovaries, has the potential to break the metabolic endocrine feedback loop and significantly reduce the metabolic and hormonal effects of PCOS.
The condition is serious with a high level of unmet need and no approved drug treatments. The burden of illness of PCOS, both individual and societal, is significant. The annual cost of treatment is estimated to be over $4 billion in the US alone. Women with PCOS have a 50% greater chance of developing Type 2 Diabetes in their 30’s and 40’s and have a 3 times greater probability of developing endometrial cancer.
PCOS represents a significant commercial opportunity with peak global annual revenues between $500M and $1B.