Celmatix Founder and CEO Piraye Yurttas Beim, Ph.D/courtesy of Celmatix
The introduction of the birth control pill in 1960 was arguably the last major advancement in a segment of the biopharma industry now known as femtech. That is changing now, as new companies form around de novo innovations that promise important advances for women’s healthcare.
Many of these advances are still in preclinical development, but Global Market Insights predicts the worldwide market for therapeutics designed specifically for conditions and diseases that affect only (or mainly) women will exceed $65 billion by 2027.
Celmatix: Ovarian Health, The complexities of the female body extend beyond reproduction. “The ovary sits at the center of not only the reproductive axis, but also the endocrine axis and the metabolic axis,” Piraye Yurttas Beim, Ph.D., founder and CEO of Celmatix, told BioSpace.
Celmatix is developing an anti-mullerian hormone receptor 2 (AMHR2) agonist that regulates the entire 300-day process of follicular genesis. In contrast, current technology regulates estrogen and progesterone, and only affects the last 30 days of the follicles’ function.
Anti-mullerian hormone (AMH) is the master regulator that determines the differing rates of decline of the ovary’s various functions. It signals through AMHR2, which is primarily found on ovarian cells.
The AMHR2 agonist is designed initially for chemotherapy-induced ovarian failure. After about six weeks of chemotherapy, the cells that make AMH undergo apoptosis.
At that point, “There’s nothing to keep the eggs and follicles in check,” Beim explained. As a result, the follicles are activated early. Consequently, the timeline (to menopause) that normally winds down from birth to about age 50, accelerates.
“For every month on very high dose chemotherapy, you lose a year and a half of your timeline to menopause. Obviously, that has implications for fertility, but…these women are [also] at significantly increased risk of acquiring diseases of aging earlier in life.”
When ovaries fail to function early in life, uterine fibroids, endometriosis, polycystic ovary syndrome (PCOS), infertility and early menopause may develop.
“PCOS, for example, is a significant risk factor for mental health issues, diabetes and insulin resistance, metabolic disorder and obesity, heart disease, certain types of cancers and infertility,” Beim said. “It is niched as a reproductive condition, even though it is actually a significant metabolic and endocrine disorder.”
Another example is endometriosis, an inflammatory disorder that increases a woman’s later risk of heart disease and stroke.
Celmatix’s recombinant, biologically active AMH compound is being designed to add back an activity that’s missing from the body, Beim said. It’s been shown to protect the ovary in animal models that were exposed to chemotherapy. “You can’t experimentally differentiate between the ovaries that were exposed to chemotherapy and those that weren’t,” she noted.
“The end of ovarian function during the menopause transition is the single biggest accelerant of the disease of aging for women,” Beim said. Therefore, “Celmatix is developing drugs to optimize the function of organs that are unique to women. This isn’t repurposing something…or targeting estrogen in yet another way. This is doing something fundamentally different.”
This AMHR2 agonist has the potential to evolve as a broad platform. Additional pipeline programs will be announced in the coming year.