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US biotech start-up launches novel PCOS drug programme
The programme is aimed at restoring ovarian function, addressing the root cause of the symptoms
The US biotech start-up Celmatix has launched a novel PCOS drug programme to address “critical” gaps in the women’s health market.
The programme, which is targeting melatonin receptors outside of the central nervous system (CNS), aims to bridge a critical gap in the market for treatments for a range of women’s health indications, starting with PCOS and with the potential to expand into the treatment of endometriosis and menopause.
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 its prevalence, 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, says Celmatix.
Its programme is aimed at restoring ovarian function in a way that addresses the root cause of all these symptoms.
The New York-based start-up has previously announced findings demonstrating rare functional mutations in the melatonin receptor genes of women with PCOS and the strong association of the melatonin receptor genes with PCOS traits.
Now, through its therapeutic programme, the company aims to develop a novel melatonin receptor agonist compound to increase therapeutic action at the target tissues, including the ovary, and minimise unwanted side effects like drowsiness.
“The ovary is not just an egg factory. It is the central command centre of a woman’s body, integrating signals from the body including stress, inflammation, and nutritional status,” explains Dr Piraye Yurttas Beim, Celmatix founder and CEO.
“Light is one of the most powerful signals that enters our body, so it was no surprise to us that genetic differences in how women’s bodies respond to light emerged in our studies as a powerful link to PCOS and PCOS-related traits.
“We are excited to not just be at the forefront of highlighting the importance of melatonin signaling for ovarian health and function but also pioneering the development of a novel melatonin receptor agonist that acts specifically in the periphery and not the brain.”
She added: “We believe this drug has the potential to support ovarian health throughout a woman’s lifespan, beginning with treating the root causes of PCOS early in life and later through enabling healthier ageing for women as their ovarian function declines through the menopause transition.”
Ovarian cancer cases are rising among younger adults in England, with bowel cancer showing a similar pattern, a new study suggests.
Researchers said excess weight is a key contributor, but is unlikely on its own to explain the pattern.
The authors wrote: “These patterns suggest that while similar risk factors across ages are likely, some cancers may have age-specific exposures, susceptibilities, or differences in screening and detection practices.”
They added: “Although overweight and obesity are linked to 10 of the 11 cancers evaluated and account for a substantial proportion of cancer cases, both BMI-attributable and BMI-non-attributable incidence rates have increased, though the latter more slowly, suggesting other contributors.”
The study analysed cancer incidence, meaning new diagnoses, in England between 2001 and 2019 across more than 20 cancer types, comparing adults aged 20 to 49 with those aged 50 and over.
Among younger women, cases of 16 out of 22 cancers increased significantly over the period, while among younger men, 11 out of 21 cancers increased significantly.
In particular, there was a significant rise in 11 cancers with known behavioural risk factors among adults under 50. These were thyroid, multiple myeloma, liver, kidney, gallbladder, bowel, pancreatic, endometrial, mouth, breast and ovarian cancers.
Rates of all 11 also rose significantly among adults aged 50 and over, with the notable exceptions of bowel and ovarian cancer.
Five cancers, endometrial, kidney, pancreatic, multiple myeloma and thyroid cancer, increased significantly faster in younger than in older women, while multiple myeloma increased faster in younger than in older men.
The researchers looked at established risk factors including smoking, alcohol intake, diet, physical inactivity and body mass index, a measure used to assess whether someone is underweight, a healthy weight, overweight or obese.
With the exception of mouth cancer, all 11 cancers were associated with obesity. Six, liver, bowel, mouth, pancreatic, kidney and ovarian, were also linked to smoking.
Four, liver, bowel, mouth and breast, were associated with alcohol intake. Three, bowel, breast and endometrial, were linked to physical inactivity, and one, bowel, was associated with dietary factors.
But apart from excess weight, trends in those risk factors over the past one to two decades were stable or improving among younger adults.
That suggests other factors may also play a part, including reproductive history, early-life or prenatal exposures, and changes in diagnosis and detection.
The study noted that red meat consumption fell among younger adults, while fibre intake remained stable or slightly improved in both sexes between 2009 and 2019, although more than 90 per cent of younger adults were still not eating enough fibre in 2018.
Established behavioural risk factors accounted for a substantial share of cancer cases.
Excess weight was the risk factor associated with most cancers in 2019, ranging from 5 per cent for ovarian cancer to 37 per cent for endometrial cancer.
The researchers said the findings were based on observational data, meaning the study could identify patterns but could not prove cause and effect.
They also noted there were no consistent long-term national data for several risk factors, that the analysis was limited to England rather than the UK, and that cancer remains far more common overall in older adults despite the rise in cases among younger people.
Early miscarriage care after a first loss could prevent about 10,000 pregnancy losses a year in the UK, according to a new study.
The study by Tommy’s National Centre for Miscarriage Research and Birmingham women’s hospital involving 406 women found a 4 per cent reduction in the risk of future miscarriage for women on the graded model of care compared with usual care.
Women in England, Wales and Northern Ireland currently become eligible for specialised NHS care for early baby loss only after they have had at least three miscarriages.
Tommy’s has called for women to become eligible after one miscarriage, saying this could reduce the risk of future miscarriages and improve health outcomes for mothers.
Researchers said that would translate to 10,075 fewer miscarriages a year across the UK.
Kath Abrahams, chief executive of Tommy’s, said women were being “left without early access to services that could help prevent future losses and reduce the debilitating feelings of isolation and hopelessness that we know affect so many who experience pregnancy loss”.
She said: “Our pilot study indicates that providing support after a first miscarriage, with escalating care after further losses, is not only effective but achievable without significant additional workload for NHS teams who are already working extremely hard to deliver good care.
“Put simply, it is the right thing to do. We will do all we can to drive that change across the UK so that more women and families are supported after every miscarriage.”
The graded model of miscarriage care proposed by Tommy’s is already available in Scotland, and the charity is calling for it to be introduced across the whole of the UK.
The graded model includes nurse-led support after one miscarriage, with advice on reducing risk factors such as low vitamin D, folic acid intake, alcohol consumption and caffeine use.
Women who received the specialised care were 47 per cent more likely to have a risk factor identified and receive relevant advice to help prevent future miscarriages than women receiving usual care, the study found.
Among women who had experienced two miscarriages and received the specialised care, one in five were found to have thyroid dysfunction or anaemia, both conditions that can affect pregnancy outcomes.
About one in four pregnancies ends in miscarriage, most often within the first 12 weeks of pregnancy.
The report comes ahead of the long-awaited final findings of the government’s investigation into maternity care in England. Interim findings uncovered a range of failures, including claims that NHS hospitals that caused harm to women and babies during childbirth often resorted to a “cover-up” of their mistakes, falsified medical records and denied bereaved parents answers.
Women’s health minister Gillian Merron said: “Pregnancy and baby loss can have a devastating impact on women and families, who too often feel they have been left without the care and support they need.
“I welcome the findings of this important report, and this will be carefully considered as part of our ongoing work to make sure women get the high-quality, compassionate NHS care they deserve.”
Indian pharmaceutical giant Sun Pharma has agreed to buy Organon for US$11.75bn in a deal aimed at expanding its women’s health and biosimilars business.
Organon, which was spun out of Merck in 2021, has built a portfolio of more than 70 women’s health and general medicines products, including biosimilars, sold in the US and about 140 other countries.
The acquisition would give Sun Pharma a broader presence in biosimilars, which are medicines designed to be highly similar to existing biological drugs, and strengthen its position in women’s health.
Dilip Shanghvi, executive chairman of Sun Pharma, said: “Organon’s portfolio, capabilities, and global reach are highly complementary to our own, and we believe that bringing the two organizations together can create a stronger and more diversified platform.”
The companies said the combined business would generate annual revenue of US$12.4bn, operate across 150 countries and rank among the top three companies globally in women’s health.
They also said it would become the seventh largest biosimilar player.
Sun Pharma said the deal would help grow its innovative medicines business and expand its biosimilars offering.
It added that the combined company would have 18 large markets each generating more than US$100m in revenue.
Organon’s largest markets include the US, Brazil, Canada, China and countries in the European Union. The company also has six manufacturing facilities across the EU and emerging markets.
The deal follows market speculation that began on 10 April, when Indian media reported that Sun Pharma had submitted an all-cash offer for Organon.
A later report said the offer had been revised to US$13bn. Sun Pharma shares rose about 7 per cent on India’s National Stock Exchange after the announcement.
Sun Pharma said it would acquire all of Organon’s issued and outstanding shares in cash, using a combination of available cash and committed bank financing. It also estimated synergies of about US$350m within two to four years of completion.
The company said the acquisition would strengthen its cash generation, with EBITDA and cash flow set to nearly double, supporting efforts to reduce the net debt to EBITDA ratio of 2.3 times resulting from the deal. EBITDA is a measure of operating performance before certain costs are deducted.
Organon reported revenue of US$6.2bn last year and adjusted EBITDA of US$1.9bn. It also reported debt of US$8.64bn, down from US$9.5bn when it separated from Merck, and a cash balance of US$574m.
In November, Organon announced plans to sell its JADA System, designed to control and treat abnormal postpartum uterine bleeding or haemorrhage, to Laborie Medical Technologies for up to US$465m. Net proceeds from the sale will contribute to Organon’s cash balance as of 31 March 2026.
Organon will merge with a subsidiary of Sun Pharma, with Organon surviving the merger. The boards of both companies have approved the transaction.
Carrie Cox, executive chair of Organon, said: “Following a comprehensive review of strategic alternatives, our Board determined that this all-cash transaction offers compelling and immediate value to Organon stockholders.”
The transaction is expected to close in early 2027, subject to regulatory approvals and Organon stockholder approval.
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