Hormone-replacement therapy was once billed as the fountain of youth for aging women facing the symptoms of menopause, until controversial studies from the past decade showed the hormones appeared to raise risks of heart attack and stroke. But hormone replacements never went completely away, and now a small Massachusetts biotech is seeking to tap new markets with a safer, synthetic form of estrogen that it hopes will benefit both women and men.
Holden, MA-based Hygeia Therapeutics is developing synthetic, topically-delivered estrogens to help maintain skin “thickness, moisture content, and elasticity,” as people age, according to its website. The technology behind this idea was licensed from Yale University chemist Richard Hochberg.Because of the lack of side effects traditionally associated with estrogen products, Hygeia’s treatments could ultimately be used to target ailments ranging from baldness to acne, in a wider range of populations than just the traditional group of women facing menopause who bought hormone replacement therapies in the past. “It will open up a market for men, since it doesn’t have a systemic effect,” says Hygeia CEO Yael Schwartz.
Hygeia’s lead pipeline product right now is HYG-102, a topical synthetic estrogen cream designed to treat skin thinning in the vaginal and vulvar regions, a condition that causes discomfort and an increase in urinary tract infections. The product targets skin thinning at the site of application, and then gets metabolized by the liver to become a completely inactive metabolite, Schwartz says. And its half-life is about seven minutes. That’s what gives it the edge over other pre-existing synthetic estrogen treatments, which don’t get fully broken down into inactive compounds, Schwartz says. “The body burden of estrogen never goes away,” in products currently on the market, which leads to the increased risks of breast cancer, uterine cancer, cardiovascular disease, and stroke that typically come with other synthetic estrogens, she says.
HYG-102 has gathered pre-clinical data and is readying itself for its first clinical trial in the next two years. The market for synthetic estrogen treatments is currently about $500 million annually in the U.S., Schwartz says, but that’s with only one in four women currently seeking treatment. That market could boom to $1 billion annually as awareness of the condition increases, says Schwartz, who previously worked at Marlborough, MA-based drugmaker Sepracor, which changed its name to Sunovion Pharmaceuticals earlier this year as a result of its acquisition by Japanese pharmaceutical company Dainippon Sumitomo Pharma.
Skin atrophy doesn’t just plague women and isn’t just restricted to the vaginal region, though, Schwartz says. Skin thins throughout the entire body as it ages, causing bruising and greater fragility, so HYG-102 could be used throughout the entire body and also by men. “We don’t know what the market is for skin fragility, except that every elderly person has it,” Schwartz says. “It’s a normal consequence of aging.”
Therapeutic applications could extend further with the synthetic hormone blocking product, HYG-440, in Hygeia’s pipeline. The topical treatment, also built on technology licensed from Hochberg’s Yale lab, could help target acne, excess facial hair in women, and androgenic baldness, Schwartz says. That product isn’t as far along in development as HYG-102, but she says the firm is expecting some “pivotal proof of concept data” on it next month.
Hygeia was founded in 2007 and raised $1 million in Series A financing this past spring. The firms’ scientific advisory board includes Hochberg, and Elkan Gamzu, also the company chairman who has experience at biotechs such as Millennium Pharmaceuticals, Epix Pharmaceuticals, and Cambridge Neuroscience. Hygeia’s plans to “stay very lean as a nod to the economy,” Schwartz says. She and co-founder Craig Abolin, also a Sepracor alum, comprise Hygeia’s full-time team and focus on drug development. Medical, legal, and financial tasks at the firm are all contracted out.
The startup is exploring options for Series B investors, but has also received interest from bigger drug companies for partnership opportunities, Schwartz says. The dermatological market is promising, because of the greater ease of conducting clinical trials and the easily observed results, she says. “There’s a real need out there for dermatological products.”
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