In vitro fertilization is a time-consuming and onerous process to treat infertility – involving scores of injections that make the regimen particularly difficult for patients.
A Massachusetts startup contends it has a better approach to infertility.
TocopheRx is developing a first-in-class, oral small molecule drug for infertility that is meant to replace the cumbersome injections currently used. It is developing a follicle stimulating hormone agonist, meant to spur increased fertility in both men and women.
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“Our business plan is all about converting in vitro fertilization into a completely oral regimen,” President Steve Palmer said in an interview at this week’s J.P. Morgan Healthcare Conference.
The Massachusetts company launched as a spinout of EMD Serono, and to date has raised $4.3 million in seed funding from Merck Serono’s investment arm, MS Ventures. The company is looking to raise $22 million in a Series A this year, aiming for a close of that round by May, Palmer said.
Along with cancer, neurology, immunology and metabolics, infertility is an important segment of EMD Serono’s R&D pipeline – hence the formation of TocopheRx.
The company is still in preclinical testing, though projects it’ll be ready to enter safety trials in humans next year. A $22 million Series A could take TocopheRx through Phase 2 proof of concept trials.
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TocopheRx is focusing on female infertility as its first indication, simply because the path to market is already well established. For men, the market is less clear, so it’ll tackle that approach after a pill for women’s infertility has been developed.
The first line of therapy for women facing infertility is to take clomiphene – but the success rate is fairly slim month-to-month. The next step is a slew of fertility injections, which is a challenging process for women – and seldom used by men.
“Guys just don’t do it,” Palmer said. “That’s why we would like to provide something that’s orally active – meaning men will be more likely to take it over six months of injections.”
But, as mentioned earlier, the target market is the women who drop out of a clomiphene regimen: Some 15 million take the fertility-enhancing drug, but 9 million quit.
“We could address around 50 percent of the women who stop taking clomiphene,” Palmer said.
And as for men – the drug could address about 15 percent of the men with infertility issues, Palmer said – specifically, those with low sperm count.
Follicle-stimulating hormone, or FSH, is the key protien hormone that drives the early development of reproductive function. It stimulates the initial events in sperm production for men, and helps women develop a mature oocyte. Luteinizing hormone, or LH, works in men to develop testosterone, and in women, it triggers ovulation.
“Our small molecules hit both FSH and LH, which means we should be able to improve the follicular maturation prior to ovulation in women – and stimulate the development of spermatogenesis in men,” Palmer said. More on the science can be found here.
Preclinical safety testing shows safe toxicology – though one notable effect is that large doses of the drug in mice – an inherently fecund species – is enlargement of the ovaries. So far, it looks as though toxicology can be managed by limiting the dose in patients, Palmer said.
[Image courtesy of Wikimedia]
