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Celmatix teams up with pharma company Aché Laboratórios to investigate PCOS drug candidate

The two companies aim to assess the potential of the drug candidate in well-established in vivo models of PCOS

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The women’s health biotech start-up Celmatix and Brazilian pharma company Aché Laboratórios have announced a collaboration and license option agreement to investigate a novel melatonin receptor drug candidate to treat PCOS.

The news follows Celmatix’s April announcement of the second of its three internal drug programmes, targeting melatonin receptors outside of the central nervous system (CNS) to address a critical gap in the market for treatments for a range of women’s health indications, such as PCOS.

Under the terms of the agreement, Aché and Celmatix will collaborate to assess the potential of the drug candidate in well-established in vivo models of PCOS.

Following successful completion of these studies, the companies intend to enter into a separate license and development agreement.

“We are excited to join efforts with Celmatix to explore the role of melatonin receptors in the context of PCOS, as well as to investigate the potential of a novel peripherally preferred melatonin receptor agonist discovered at Aché in restoring ovary function in these patients,” said José Vicente Marino, Aché CEO.

“Aché’s expertise in the research, development, and commercialisation of medicines, in conjunction with Celmatix’s cutting edge know-how in the identification and validation of drug targets in the women’s health field, will synergise for advancing the knowledge about PCOS and developing new medicines for treating the disease.”

PCOS is known primarily for being one of the most common causes of female infertility, affecting around 15 per cent of women of reproductive age.

However, disrupted ovarian physiology in women experiencing PCOS has also been shown to impact endocrine, immune, metabolic, cardiovascular, and mental health functions.

Despite the prevalence of PCOS, no drug has ever been developed specifically to treat it. The existing standard of care for PCOS focuses on symptom management, including birth control pills to regularise periods, metformin to address insulin resistance, statins to control high cholesterol, ovarian stimulation for ovulatory dysfunction, and cosmetic procedures to remove unwanted hair.

Celmatix’s programme aimes to restore ovarian function in a way that addresses the root cause of all these symptoms.

“We know there is a compelling link between melatonin signalling outside of the CNS and endocrine, metabolic, and reproductive traits in women with PCOS,” said Celmatix founder and CEO, Dr Piraye Yurttas Beim.

“However, melatonin and existing selective melatonin receptor agonists are not viable therapeutics for ovarian health conditions because they have potent CNS-activity that creates significant side effects, including nausea and drowsiness.

“We are thrilled to be able to advance our PCOS Melatonin Program through our collaboration with Aché.

“By focusing on melatonin receptor action outside of the CNS, through this joint development and licensing option agreement with Aché, we are one important step closer to being able to offer relief to the millions of women with a range of ovarian health conditions, including PCOS.”

Sorina Mihaila is the Femtech World editor, covering technology, research and innovation in women's health and wellbeing.

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Labcorp launches screening test to identify preeclampsia risk sooner

The new screening tool is capable of assessing the risk of preeclampsia sooner, the test maker says

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Labcorp has launched a screening test that can assess the risk of preeclampsia before 34 weeks of pregnancy.

Preeclampsia is a high blood pressure disorder that can develop during pregnancy or postpartum and is a leading cause of maternal morbidity and mortality worldwide.

Roughly one in 25 pregnancies in the US is affected by preeclampsia, which poses an even greater risk for non-Hispanic black women, who experience the condition at a 60 per cent higher rate compared to white women.

In January, Labcorp announced the launch and availability of an FDA-cleared blood test for risk assessment and clinical management of severe preeclampsia during the second and third trimesters.

The first trimester test uses four early pregnancy biomarkers to provide a risk assessment with up to 90 per cent sensitivity, nearly twice the sensitivity of assessing typical maternal history or biophysical factors alone.

According to Labcorp, the test results provide risk identification earlier than traditional symptoms, such as hypertension or protein in the urine, which tend to develop around 20 weeks gestation.

Eleni Tsigas, chief executive officer of the Preeclampsia Foundation, said: “Our organisation celebrates this innovative new test offering.

“Research shows that patients and providers want access to more tools that better predict progression to preeclampsia, especially for those patients with low- to average-risk or those with first-time pregnancies for whom there is some uncertainty.”

Dr Brian Caveney, chief medical and scientific officer at Labcorp, added: “Labcorp is committed to advancing maternal and foetal health through innovative diagnostic and screening solutions.

“This new first trimester blood test is another significant milestone in our mission to improve health and improve lives. By giving healthcare providers another tool to assess preeclampsia risk in their pregnant patients with objective biomarkers, we’re helping to advance prenatal care and improve outcomes for mothers and their babies.”

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People with HIV can be sperm and egg donors

A change in law will allow people with non-transmissible HIV in the UK to donate gametes to partners

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Same-sex couples with non-transmissible HIV will now be able to donate eggs or sperm and become parents.

People with HIV will able to donate their sperm or eggs to their partners, as the law in the UK is updated.

The Human Fertilisation and Embryology Act will be amended via a statutory instrument to allow people with non-transmissible HIV – with a viral load low enough not to pass on – to donate eggs or sperm, known as gametes, as part of fertility treatment to their partners.

Under current rules on IVF, only a male partner with HIV can give their sperm to their female partner and not to anyone else.

The law change will also eliminate extra screening costs for female same-sex couples undertaking reciprocal IVF treatment.

The government says this is part of wider work to improve access to IVF for everyone and ensure same-sex couples have the same rights as a man and woman when trying to conceive.

“These changes will allow more people to fulfil their dream of becoming parents,” said UK health minister, Maria Caulfield.

“We have changed the law to ensure equality for people living with HIV when accessing IVF, allowing them to donate their eggs and sperm.

“In addition, the change will allow female same-sex couples to access IVF with no extra screening costs, the same as heterosexual couples.”

She added: “These changes will help create a fairer system by removing barriers to accessing fertility care as we have set out in the Women’s Health Strategy.”

The changes to the law will allow people with HIV to donate their gametes to family, friends and known recipients.

The regulations include an updated definition of partner donation to enable female same-sex couples wishing to donate eggs to each other to undergo the same testing requirements as heterosexual couples.

Under current rules, female same-sex couples hoping to conceive via reciprocal IVF must first go through screening for syphilis and genetic screening, such as cystic fibrosis, which can cost over £1,000, while heterosexual couples do not need to undergo this screening.

Julia Chain, chair of the Human Fertilisation and Embryology Authority (HFEA), said: “The HFEA welcomes the news that legislation regarding partner donation in relation to reciprocal IVF, and gamete donation from those who have HIV with an undetectable viral load, has now been proposed in Parliament.

“Fertility treatment is helping more people than ever to create their family, and everyone undergoing fertility treatment should be treated fairly.

“For known donation from individuals with undetectable HIV, we anticipate that the first clinics may be able to begin to offer this treatment around 3 months following a change in the law.

“We encourage any patients or donors who may be affected by these changes to visit the HFEA website to find out free and impartial information, including about how to choose a fertility clinic.”

Minister for equalities, Stuart Andrew MP, added: “Treatment for HIV has improved significantly, saving countless lives, but the stigma surrounding it persists – a stigma which often prevents people from getting tested and seeking treatment.

“These changes will help to reduce that stigma, making it clear that people with HIV can live full and happy lives. I am delighted by these changes which will enable more people to experience the joy of becoming parents.”

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Portfolia invests total of US$65m into women’s health companies

The platform has invested in 47 femtech start-ups to date

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Trish Costello, founder and CEO of Portfolia

The US venture investing platform Portfolia has announced it has invested a total of US$65m into women’s health companies and solutions.

Portfolia aims to create, educate and support the largest community of women investors in the world.

The company says it was amongst the first to recognise the “immense” potential of women’s wealth, with women’s health at the forefront.

To date, Portfolia has made investments in 112 companies with 47 of those women’s health companies being femtech and active aging specific.

Some of these include Madison Reed, Maven, Everly Health, Bone Health, Veana, Your Choice, Future Family, Willow, Hey Jane, Lighthouse Pharma, L-Nutra and JoyLux.

The total companies Portfolia has invested in are estimated to serve over 102 million customers in 115 countries worldwide.

These companies have a combined value of over US$17bn, with over US$1bn in revenue and 10,000 employees worldwide.

According to Portfolia, almost 70 per cent of these businesses are led by female CEOs, and 49 per cent are led by BIPOC individuals.

“At Portfolia, we believe in the power of activating our wealth for returns and impact,” said Trish Costello, founder and CEO of Portfolia.

“Today, women in the United States have unprecedented access to wealth – with over US$25tn of wealth in the US and almost 50 per cent of it owned by women.

“This wealth is power – power to create financial change and invest in the companies and businesses that matter to us and meet our needs/desires.”

She added: “Our commitment goes beyond traditional venture capital – we’re pioneering change, saving lives, and creating opportunities for all, while creating the most powerful community of women investors globally, and the first to activate our wealth to shape the future of healthcare.”

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