Successes and setbacks for women’s health specialist Mithra

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It has been a year with ups and downs for Mithra – the Liège-based specialist in women’s health. The company experienced huge success with its pioneering contraceptive pill Estelle, which became available in regions all over the world. But the company also discontinued the research program of another product, PeriNesta, developed to battle symptoms arising during menopause. Overall the company is doing good work though, developing innovations in a field that has historically been neglected.

Mithra has a history dating back to 1999, when entrepreneur François Fornieri – until recently CEO of the company – joined forces with Prof. Jean-Michel Foidart of the University of Liège. “From the very beginning, the focus lay very strongly on innovation in the women’s health sector,” says Jean-Manuel Fontaine, head of external and scientific affairs at Mithra.

This year, the company achieved an important breakthrough with its novel contraceptive pill Estelle. The product was introduced on the market in the US, Canada, and different European countries including Belgium. What makes Estelle different is that contains estetrol (E4), a natural estrogen produced by the human fetus during pregnancy, which Mithra has managed to produce from plant sources. Most other contraceptives are based on the synthetic estrogen ethinylestradiol (EE).

“Because of E4, Estelle is effective without disrupting the hormonal balance, and has a much lower impact on the bodies of women than traditional contraceptives,” explains Fontaine. “Among other things, Estelle has a lower impact on triglycerides, cholesterol and glucose. It furthermore offers protection against venous thromboembolism (VTE, ed.) and produces less side effects such as breast tension.” According to Fontaine, the new pill is “bringing about a new era in contraception, 60 years after the first oral contraceptive was approved.”

Help for menopausal women

Mithra also has another product in the pipeline that is based on the beneficial effects of estetrol: Donesta. Donesta is a product candidate for a new generation of hormone therapy to combat different symptoms affecting women in their menopause, such as hot flashes and night sweats. Because of problems with clinical trials caused by the COVID-19 crisis, the Donesta research program has suffered a delay in Europe. “But we’re still very much on track in the US,” says Fontaine. He believes the product could be introduced to the market in 2024.

“Because of E4, Estelle is effective without disrupting the hormonal balance, and has a much lower impact on the bodies of women than traditional contraceptives.” – Jean-Manuel Fontaine

Another research program for an E4-based product, PeriNesta, has recently been discontinued. PeriNesta, which was planned to become available on the market in about two years, was meant to be the first product on the market for perimenopausal women. During this intermediate phase, women may already suffer symptoms such as hot flashes and night sweats. PeriNesta would battle these symptoms while also providing effective contraception. “This program has now been discontinued, but that doesn’t mean we are throwing it away,” stresses Fontaine.

Not just women’s health but also COVID-19

Mithra also suffered a slight setback in its Coronesta program, which examined the possible benefits of estetrol for patients who were hospitalized with moderate COVID-19. The results of the Phase II study showed that E4 didn’t have any more positive effects than the placebo had. “The study did however again confirm that E4 is very safe to use; there were no adverse effects.” Mithra is also investigating a number of other applications of E4 in diverse fields, such as wound healing and neonatal asphyxia.

In addition to the Coronesta program, the company is taking further action in the battle against COVID-19 through a collaboration with ExeVir Bio, a VIB spin-off making headlines with its llama-derived antibody therapies. ExeVir has developed a candidate medicine against the viral disease, which will be produced in Mithra’s state-of-the-art production platform CDMO.

Read this article to find out how ExeVir has been countering COVID-19 using llama antibodies.

New roadmap and CEO

Apart from its E4-based solutions, Mithra is also developing complex products using medical polymer technology. About five years ago, it launched Tibelia: a therapy against menopausal issues composed of Tibolone, a synthetic steroid used for hormone therapy. It currently is also working on a novel contraceptive vaginal ring (Myring) and a biodegradable subcutaneous implant (Zoreline) for hormone-dependent cancers.

Looking back on this historic year, Fontaine sees more ups than downs. “We have reached very important milestones and have created a roadmap with our new CEO,” he states. Current CEO Leon Van Rompay took over from François Fornieri early this year, and in the press release accompanying his confirmation by the board commented: “Mithra can pride itself on having successfully completed the ultimate challenge for any biotech: succeed in launching an innovative molecule on an international scale.”

Fontaine also points to the first earnings that they received from the commercialization of Estelle, which amounted to more than 6 million euros. That Mithra’s R&D costs are still higher than its income is not a surprise, he says. “We are on the right track, the outlook for the coming years is very good.”