Fertility
$2.5m grant to support development of novel contraceptive technology
Women’s health company Daré Bioscience has recieved a $2.5m grant to advance the development of its investigational contraceptive DARE-LARC1 through non-clinical proof of principle studies and other IND-enabling work.
DARE-LARC1 is a potential new category of long-acting, reversible contraceptive (LARC). If successfully developed and approved, DARE-LARC1 could provide women with a higher level of control over the management of their fertility.
As with other types of LARC products, investigational DARE-LARC1 is intended to provide effective contraception for an extended period without requiring day-to-day effort.
DARE-LARC1 enables precision dosing, extended device duration and wireless control, and utilises levonorgestrel, which is the active pharmaceutical ingredient in a number of FDA-approved birth control methods.
The company has said it intents to submit an Investigational New Drug (IND) application with the FDA.
“This latest instalment continues to validate our progress and the importance of developing this technology, which can be used to address meaningful unmet needs in reproductive health as well as other therapeutic areas including diabetes, obesity, and other conditions requiring precise and prolonged treatment,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
Under the terms of the grant agreement, Daré may receive a total of up to approximately $49m to support nonclinical development of DARE-LARC1, having so fae received payments totalling approximately $31.8m. Additional payments are conditioned on the program meeting specified development and reporting milestones.
Key features of the implant technology include precision dosing, duration and dosing interval control, no external charging or recharging required, and upgradable platform that enables device software to be updated without removal or replacement of the implant, two-way communication, and smartphone integration.
Fertility
Most NHS regions in England limit IVF to single cycle, research finds
Nearly 70 per cent of NHS regions in England fund only one IVF cycle for women under 40, breaking national guidelines, new research has found.
Twenty-nine of the 42 integrated care boards, which control local NHS budgets, now offer only one round of treatment, after four reduced access in the past year.
National Institute for Health and Care Excellence (Nice) guidelines recommend three full cycles for women under 40 who have been unable to conceive for two years.
Only two of England’s 42 integrated care boards have policies consistent with these guidelines, which they are not legally obliged to follow.
The research was conducted by the Progress Educational Trust, a fertility charity.
Sarah Norcross, the director of PET, said the impact was “devastating” for couples struggling with infertility.
She said: “Infertility is already incredibly stressful for people, and it puts them under even more pressure, because there is so much riding on whether that one NHS-funded cycle is going to work.
“And for some people, that will be their only chance, because private fertility treatment is so expensive.”
The data showed regional variations, with the whole of the north-west offering just one cycle.
“It’s a postcode lottery, and we’re seeing a race to the bottom,” said Norcross.
Of the 29 integrated care boards that offer a single cycle, 19 provide only a partial cycle, where not all viable embryos created are transferred.
There was just one recent example of improved services, from NHS South East London, which in July 2024 went from one partial to two full cycles.
The NHS estimates that about one in seven couples may have difficulty achieving a pregnancy. One cycle of IVF can cost from £5,000 at a private clinic.
Fertility rates in England and Wales have fallen since 2010 to 1.41 children per woman in 2024, the lowest on record and below the replacement level of 2.1 at which a population is stable without immigration.
Health minister Karin Smyth said in a written parliamentary answer last month that it was “unacceptable” that access to NHS-funded fertility services varied across the country.
Revised Nice fertility guidelines are due this spring, but Norcross said changing them seemed pointless.
She said: “Fertility treatment has always been a Cinderella service. It’s always been the one they’ve chosen to cut or to ignore.
“Nice has recommended three full NHS-funded cycles, for women under 40, for more than 20 years. This has never been implemented across England, unlike in Scotland.”
Norcross advocated centralised commissioning and replicating Scotland’s approach, which included financial modelling and a phased implementation starting with two cycles to avoid long waits, moving up to three once capacity was achieved.
“It is a tried and tested plan that England could follow,” Norcross added.
A Department of Health and Social Care spokesperson said: “We recognise access to fertility treatment varies across the country and we are working with the NHS to improve consistency.
“Nice provides clear clinical guidelines, and we expect integrated care boards to commission treatment in line with these.
“Updated Nice fertility guidelines are expected this spring and we will continue to support NHS England to make sure the guidance is fully considered in local commissioning decisions.”
An NHS England spokesperson said: “These clinical services are commissioned by integrated care boards for their area based on the needs of the local population and prioritisation of resources available.
“All ICBs have a responsibility to ensure services are provided fairly and are accessible by different population groups.”
Entrepreneur
Merck partners on intravaginal drug delivery device
Calla Lily Clinical Care has partnered with Merck to support the intravaginal drug delivery platform Callavid in an effort to improve how vaginal medicines are given.
The collaboration will continue development of Callavid, described as a leak-resistant device that addresses challenges with self-administered vaginal therapies.
Callavid uses a small, tampon-shaped device with an integrated absorbent liner. It is inserted, remains in place during drug absorption, then is removed.
The platform is intended for use with medicines in fertility treatment, oncology and hormone therapy. Administration via the vaginal route can prompt patient anxiety about positioning, dosing accuracy and leakage.
The partnership is the first industry collaboration for the Callavid technology, which was developed by Calla Lily Clinical Care.
Thang Vo-Ta, co-founder and chief executive of Calla Lily Clinical Care, said: “This collaboration with Merck marks an important milestone in the development of Callavid, our novel vaginal drug delivery platform.
“Merck’s scientific heritage and forward-looking approach to innovation make them an ideal partner as we work to address long-standing unmet needs in women’s health.
“By improving how vaginal therapeutics are delivered and experienced, Callavid has the potential to enhance both patient outcomes and quality of life.
“We see this collaboration as a meaningful step towards translating our technology into real-world clinical and patient impact.”
Calla Lily Clinical Care is seeking to develop what it describes as the world’s first drug-device combination product to prevent threatened miscarriage and for IVF luteal phase support, the phase after ovulation when the body produces progesterone to support early pregnancy.
The device is also being developed to deliver therapeutics for oncology, menopause, infectious diseases and live biotherapeutics to reduce repeated antibiotic use.
Dr Lara Zibners, co-founder and chairman of Calla Lily Clinical Care, said: “Our initial engagement with Merck through the Merck Innovation Challenge in October 2024 was an important moment of alignment around the need for more patient-centric innovation in women’s health.
“As both a clinician and a patient, I have seen how profoundly drug delivery can shape treatment experience.
“This collaboration builds on that early dialogue and reflects a shared interest in rigorously exploring new approaches that may improve how therapies are delivered and experienced by patients.”
Fertility
France urges 29-year-olds to start families now
France is urging 29-year-olds to have children as part of a 16-point plan to boost fertility and raise birth rates.
Health officials say the aim is to prevent men and women facing fertility problems later in life and thinking “if only I had known”.
The strategy comes as the country, like many western nations including the UK, faces tumbling birth rates.
The trend is creating concerns about how governments can fund pensions and healthcare for ageing populations with fewer younger working people paying taxes.
But policies to raise fertility rates globally have produced limited results, and critics of the scheme suggest better housing and maternity provision could be more effective.
The government will send out “targeted, balanced, and scientifically sound information” to young people on issues including sexual health and contraception.
The material “will also reiterate that fertility is a shared responsibility between women and men,” the country’s health ministry said.
The plan includes efforts to increase the number of egg-freezing centres from 40 to 70. The process involves extracting and storing a woman’s eggs for potential future use.
The country’s health system already provides free egg-freezing for people aged 29 to 37, a service that costs about £5,000 per round in the UK.
The country’s fertility rate of 1.56 children per woman is below the 2.1 needed to maintain a stable population.
However, it is higher than rates in China, Japan and South Korea, and the UK, where the latest figures show it dropped to a record low of 1.41 in England and Wales by 2024.
Professor François Gemenne, who specialises in sustainability and migration at HEC Paris Business School, told Sky News: “This is something that demographers had known for a long time, but the fact that there were more deaths than births in France last year created a shock effect.”
He said the country’s “demographic worry” is exacerbated by the design of its pensions system and its “obsession with immigration and the fear of being ‘replaced'”.
The plan also includes a new national communication campaign, a “My Fertility” website advising on the effects of smoking, weight and lifestyle, and school lessons for children about reproductive health.
The health ministry has acknowledged its maternal and infant mortality rates are higher than neighbouring countries and is beginning a review of perinatal care to address the “concerning” situation.
Channa Jayasena, professor in reproductive endocrinology at Imperial College London, told Sky News: “On the female side, societal changes leading to older age of motherhood are certainly important.
He said obesity was also a problem as it increased women’s risk of polycystic ovary syndrome and endometriosis.
Allan Pacey, professor of andrology (male reproductive health) at Manchester University, said for most people globally, deciding to have children was “down to [non-medical] factors such as better access to education, career opportunities, taxation, housing, mortgages, finance, etc.”
“Medicine can’t help with those things,” Pacey added.
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