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Positive clinical results for fibromyalgia behavioural therapy treatment

Company aims to use the treatment to help adult patients manage the psychological symptoms of fibromyalgia

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Women are reported to be twice as likely to suffer from fibromyalgia as men

The digital therapeutics company Swing Therapeutics has announced positive results following the clinical trial of its behavioural therapy solution for fibromyalgia.

The US company has reported early results from a prospective single-arm clinical trial, presented at the American College of Rheumatology (ACR) annual meeting.

Stanza, a prescription smartphone-based digital therapeutic, was developed by Swing Therapeutics for the management of fibromyalgia – a condition that causes widespread musculoskeletal pain, fatigue, sleep, memory and mood issues.

The core of the treatment is acceptance and commitment therapy (ACT), a type of cognitive behavioural therapy (CBT) with proven efficacy in treating the disorder.

The company says Stanza is designed to help adult patients manage the psychological symptoms associated with fibromyalgia, including anxiety, depression, and sleeplessness.

“This real-world data expands the growing body of clinical evidence supporting the use of digital therapeutics for the management of fibromyalgia, and reinforces the positive outcomes observed from a previous randomised controlled trial,” said Mike Rosenbluth, founder and CEO of Swing Therapeutics.

“As we gather additional compelling evidence, our mission is to make digital behavioural therapeutics like Stanza become more accessible to people with fibromyalgia.

“The launch of Swing Care – a Texas-based clinic focused on the treatment of fibromyalgia – is an exciting step toward broadening the reach of telemedicine and digital health to a wider population of patients.”

Andrea Chadwick, medical director of Swing Care, said: “People living with fibromyalgia often fall through the cracks of healthcare and better solutions are needed to improve the quality of their lives. This clinical data demonstrates the power of digital behavioural therapeutics to make a meaningful difference.”

Swing Therapeutics looked at the clinical impact of a digital behavioural therapy for fibromyalgia management in a decentralised trial where participants were primarily evaluated using the Patient Global Impression of Change (PGIC) Scale.

At the end of the course of a 12-week therapy, participants with fibromyalgia achieved improvement in all areas measured, with 84 per cent of them reporting improvement in their condition after Stanza treatment.

Yifei Dai, head of clinical and scientific affairs at Swing Therapeutics, said: “People with fibromyalgia have no cure for their condition, and often have trouble managing symptoms, including pain, brain fog, sleep disturbances and anxiety and depression.

“I’m encouraged by the results we saw from patients throughout the study and look forward to gathering additional evidence.”

Swing Therapeutics also reported results of usability research on Stanza that was conducted as part of the REACT-FM trial. 

In this study, participants evaluated the treatment’s ease of use, interface, and overall satisfaction via the mHealth App Usability Questionnaire (MAUQ) at the end of the 12-week treatment.

Treatment preference for the digital therapeutic application versus medication management was evaluated for participants who currently or previously used FDA-approved pharmacological treatments for fibromyalgia.

At the end of the programme, 84 per cent and 88 per cent of participants reported positive ratings in the MAUQ domains of ease of use and interface and satisfaction, respectively.

The company found that approximately 90 per cent of those who had used FDA-approved fibromyalgia medications preferred treatment with Stanza, or Stanza combined with approved fibromyalgia medication, versus treatment with approved medication alone.

Nelson Mitchell, head of product at Swing Therapeutics, said: “Other self-guided digital behavioural therapies on the market have been created to address accessibility and scalability issues, but many have low engagement due to poor usability.

“We’re encouraged by the positive results from this study that support our therapy’s usability and satisfaction for fibromyalgia management.”

Sorina Mihaila is the Femtech World editor, covering technology, research and innovation in women's health. Sorina is also a contributor for the neuro-rehabilitation magazine NR Times.

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Lawyers warn of discrimination risks around lack of menstrual health support in the workplace

Employers should consider proactively supporting women in managing menstruation at work, lawyers have argued

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Employers should consider the potential discrimination risks around menstrual health in the workplace, lawyers have warned, as research shows that most women in the UK feel unsupported.

According to the Chartered Institute of Personnel and Development (CIPD), the majority of women in the UK do not feel a strong sense of support in their organisation in relation to their menstrual cycle.

Figures show women are more likely to feel supported by colleagues than by their employer or manager, with only one in 10 reporting that their organisation provides support for menstruation and menstrual health.

Annisa Khan, employment lawyer at Farrer & Co who has previously raised the alarm over the lack of practical measures to support women with their periods, told Femtech World that employers should be mindful of the legal risks related to managing menstruation.

“Under the Equality Act 2010, it is unlawful to discriminate against employees based on sex, age, or disability,” she said.

“Employers should therefore consider the potential discrimination risks in relation to managing mensuration in the workplace and implement measures to reduce these risks.”

A lack of workplace period policies has been estimated to cost businesses over £6bn per year, as menstrual symptoms cause women to miss an average of 8.4 days per year due to lower productivity.

Khan said organisations should consider proactively supporting employees in managing menstruation at work by reviewing existing policies, including sickness absence and health and wellbeing policies, to ensure they effectively address menstrual-related concerns.

“Creating an open and supportive environment is crucial for employees to feel comfortable discussing periods at work,” she explained.

“This involves raising awareness among all staff, including senior-level managers and male colleagues, to foster an understanding of how colleagues may be affected by menstruation, the relevant policies and how to have open and empathetic conversations.

“Implementing practical measures is also essential to create a supportive environment. Practical steps can include having accessible bathroom facilities with sanitary bins, providing free period products to employees, offering additional breaks and providing a quiet space for rest.”

In line with CIPD’s findings, Khan said workplaces should also consider implementing more flexible working practices and giving women more breaks when needed.

“Employers should be open to employees adjusting their work pattern on the days they are experiencing menstruation symptoms by, for example, offering employees the opportunity to work from home.

“Additionally, they should consider the needs of employees with disabilities or those with medical conditions, and how they may be affected by managing mensuration at work.”

Heidi Watson, employment partner at Clyde & Co, said employers should ensure they avoid breaching discrimination laws when approaching issues like menstrual health.

“As awareness of menstrual issues such as endometriosis grows and as employees are more willing to discuss their symptoms at work, employers will need to consider whether employees are disabled under the legal definition and therefore entitled to protection from less favourable treatment and subject to the duty of the employer to make reasonable adjustments for them,” she told Femtech World.

“Employees may also be able to establish sex or age discrimination claims. We can expect more claims to come before the Employment Tribunal in the not too distant future, in a similar way as we have seen with cases involving menopause in recent years.

“Adopting a flexible approach to managing those with menstrual symptoms which are impacting their work, and creating an open and supportive culture around the issue, will help to reduce the risk of such claims being brought,” she added.

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OB/GYN-founded vitamin company pledges US$10m to improve women’s health research

Perelel aims to close the divide on women’s reproductive health research and improve access to nutritional support

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Alex Taylor and Victoria Thain Gioia, co-founders of Perelel

The US OB/GYN-founded vitamin company Perelel has pledged US$10m to Magee-Womens Research Institute and Good+ Foundation to fund women’s health research and address gaps in maternal healthcare.

The vitamin company said the US$10m would be distributed as both in-kind product donations and funding grants through 2027 focused on advancing women’s reproductive health.

Magee-Womens Research Institute is the largest US research foundation focused exclusively on women’s health, reproductive biology and infant research and care.

Good+Foundation is a national nonprofit working to dismantle multi-generational poverty by pairing tangible goods with innovative services for under-resourced individuals.

“As the only female OB/GYN-founded women’s vitamin company, Perelel is committed to ensuring that all women have access to medically backed care,” said Victoria Thain Gioia, co-founder and co-CEO of Perelel.

“This is why we are devoted to furthering women’s research in partnership with Magee-Womens Research Institute and creating more equity in the way underserved communities receive critical prenatal micronutrients that would otherwise be inaccessible thanks to Good+Foundation.”

Research shows that medical studies have historically excluded female participants and data have been collected from males and generalised to females.

The exclusion of women of “childbearing potential” from clinical research studies has meant that women’s diseases are often missed, misdiagnosed or remain a total mystery.

Alex Taylor, co-founder and co-CEO and of Perelel, said: “We recognise how wildly complex women’s bodies are — bodies that have historically been oversimplified, objectified and shamefully under-researched in medicine.

“Unfortunately, it’s not as simple as ’12 essential nutrients.’ In founding Perelel, we hope to shine a light on how dynamic our bodies are by supporting them with targeted solutions made by the doctors and experts who know best.

“Core to what we stand for is the need to keep fighting for our fundamental rights and help close the women’s health research gap and improve body literacy.”

Perelel’s pledge comes at a time of intensified focus on women’s health as efforts start to reach new levels, including the White House, after President Joe Biden announced the first-ever initiative on Women’s Health Research in 2023.

“It is critical that there is more in-depth medical research done to support women at every hormonal life stage,” said Michael Annichine, CEO at Magee-Womens Research Institute and Foundation.

“Perelel has committed to a cash donation to further advance research into women’s reproductive health and to ensure that this research is made more accessible to doctors everywhere.”

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New treatment could ‘disrupt’ growth of breast cancer tumours

A new type of immunotherapy could lead to pioneering treatment for breast cancer

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A breakthrough injection could “disrupt” the growth of breast cancer tumours, paving the way for a pioneering new treatment.

Breast cancer is the most common cancer in the UK with one woman diagnosed every 10 minutes. Around 55,000 women in the UK are diagnosed with breast cancer every year and 11,500 die from the disease each year.

Researchers from the Institute of Cancer Research have found that a new type of immunotherapy that targets non-cancer cells could help prevent the growth and spread of breast cancer tumours.

The discovery, published in The Journal for ImmunoTherapy of Cancer, has found that an immunotherapy approach targeting a protein, called endosialin, disrupts the tumour’s blood supply and, as a result, can hinder its growth and spread.

Unlike most cancer treatments, this innovative treatment does not target cancer cells directly but attacks the cells that support the disease instead.

Researchers used a type of immunotherapy called CAR-T therapy, which involves removing a patient’s healthy immune cells and genetically modifying them to attack specific targets.

CAR-T therapies are already being used to treat some blood cancers, and scientists are trying to find ways to make them effective for other types of cancer, including breast cancer.

However, CAR-T cell therapy does not always work on tumours because their environment suppresses the immune response, and it can also be challenging to find specific features on the breast cancer cells to target.

To work around these challenges, the team directed the CAR-T cells to cells surrounding the tumour’s blood supply that make the endosialin protein, rather than actual cancer cells. In experiments in mice, scientists found that targeting endosialin successfully reduced the breast cancer’s growth and spread.

The team, based at the Breast Cancer Now Toby Robins Research Centre at The Institute of Cancer Research (ICR), also tested the treatment on lung cancer tumours in mice and saw similarly successful results, suggesting patients with other types of cancer could benefit from this new treatment too.

In addition, researchers found that the CAR-T therapy did not affect cells without endosialin, indicating this could work as a cancer-specific treatment with potentially fewer side effects for patients.

“This is the very first study that demonstrates the effectiveness of using endosialin-directed CAR-T cells to reduce breast cancer tumour growth and spread,” said Dr Frances Turrell, study co-leader and postdoctoral training fellow in the division of breast cancer research at the Institute of Cancer Research.

“Immunotherapy has had limited success in treating breast cancer but by targeting the cells that support the tumour and help it to survive, rather than the cancer cells directly, we’ve found a promising way to overcome the challenges posed by the tumour environment and develop a more effective and targeted treatment for breast cancer.

“We could not have done this project without funding to the Molecular Cell Biology group from Breast Cancer Now and we hope that further research will help translate these findings into targeted therapies for breast cancer patients.”

Dr Simon Vincent, director of research, support and influencing at Breast Cancer Now, said: “This exciting research could lead to much-needed targeted treatments for people with breast cancer, and with one person dying from breast cancer every 45 minutes in the UK, new treatments like these are urgently needed.

“Now we know that the treatment works in principle in mice, Breast Cancer Now researchers can continue to develop this immunotherapy to make it suitable for people, as well as to understand the full effect it could have and who it may benefit the most.”

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