What started simply as an astute hypothesis and proverbial apple on the head has evolved into a nearly decade-long labor of love for Debra Duke.
“I just made a clinical observation,” said Duke, the founder and CEO of Aurora-based bioscience company MenoGeniX.
That was in 2008, when the Montreal native was given a medication to bolster her body’s production of neutrophils, a particular subsidiary of white blood cells. Also in the midst of menopause, Duke noticed that the drug, called Neupogen, seemed to radically reduce the number of hot flashes she was experiencing. She mentioned the occurrence to her husband, trained immunologist, Colorado bioscience juggernaut and co-founder of the Colorado Institute for Drug, Device and Diagnostic Development, Richard Duke, who encouraged her to pursue the observation further. One filed patent, a successful round of equity financing and a confirmatory Phase 1b clinical trial later, and Debra’s original anecdotal thought had blossomed into fruition.
“There are a lot of blockbuster drugs that are the result of unexpected or accidental observation,” Debra said. “Viagra is a perfect example as it was originally in trials as a heart therapy. The difference is that a drug like that was being funded by an innovator company that owns the technology and patent…(whereas) here I made a clinical observation and filed the patent myself. It’s quite a process writing a life science patent, and was a little scary, but it was one step at a time.”
The market of available drugs intended to treat menopausal symptoms is poised for a shakeup, according to Debra, who said that there is a significant lack of options for women seeking menopausal relief. She added that there are only two approved therapies to treat severe menopausal symptoms, one being a hormone therapy and the other an anti-depressant — both of which have “box warnings” or the potential for negative side effects. The drug Debra’s developing, dubbed MNGX-100, uses a naturally occurring protein to act on a person’s hypothalamus, which regulates body temperature.
“It just seems that the medical community is looking for a new alternative,” she said.
Last month, the company was selected as a Top 100 North America winner by Red Herring, a business magazine that recognizes companies that appear prepared to disrupt the status quo of an industry.
Part of the appeal of MNGX-100 is that the drug can also be effective on women who have menopause surgically induced. That’s a demographic that has seen a major uptick in recent years largely due to high-profile people such as Angelina Jolie Pitt undergoing the procedure, according to Debra. Jolie Pitt elected to have her ovaries and fallopian tubes removed, which induces menopause, earlier this year after discovering she was predisposed to certain cancers.
“Annually there are over 600,000 women who have oophorectomies, or surgically induced menopause, in the United States alone, and with the Angelina Jolie effect I think that number is just going to increase,” Debra said. “It’s anticipated that women will go to the doctor and say, ‘I want what Angelina Jolie had.’ And unfortunately, naturally occurring menopause is a more gradual experience whereas women coming out of surgery have very, very intense hot flashes.”
Debra said that although the potential commercialization of MNGX-100 is still a few years out, the timeline has been exceptionally expedited due to the fact that the original form of the drug — the one she took in 2008 to maintain her neutrophils — has been on the market since 1991 and prescribed to more than 9 million patients. That means it can skip what sometimes turns into decades of expensive approval processes and other hurdles.
“Our development time still has probably three or four years and an estimated $30 million to go until commercialization,” Debra said. “But for other drugs in the development pipeline, it’s typically hundreds of millions of dollars — we started further down the pipeline than most.”
April Giles, president of Colorado Bioscience Association, said the fact that MenoGeniX is composed of a husband and wife team deeply entrenched in the industry gives the company a prodigious chance to succeed.
“(Richard and Debra) have the background to make significant progress, so it’s exciting for Colorado to have a leadership team like that,” Giles said. “They know what they’re doing and really have a great shot at getting to their end goal with the talent and technology that they have.”
IDK, i guess