[VDP-49] MenoAge - A glycomics-based blood biomarker for female aging

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One-liner
Glycomics based test for detection of perimenopause and menopause transition to enable timely access to therapy

Shepherds: Maria Marinova#8954 MU#8083
Evaluation Team: Lutz#8525 Sebastian Brunemeier#8796 Tovah#4336

Summary

MenoAge is a perimenopause diagnostic, which is an accurate, rapidly deployable, and cost-effective. It assesses the long-term impact of common therapeutic interventions for management of menopause or of premature ovarian insufficiency impacting women´s health and longevity. Early detection of perimenopause will lead to prompt, personalized treatment, thus preventing and alleviating (peri)menopausal symptoms associated with aging and improving future health by reducing the risk of age-related diseases and mortality.

Motivation

Briefly describe what problem this aims to solve. Why is this a problem worth solving? If this impacts the user, explain how it impacts them. If it helps, frame the problem as a pain point to the VitaDAO community.

While women live longer than men on average, they spend more time in poor health with increased incidence of age-related diseases commonly associated with menopause. Menopause can have severe health and psychological consequences such as heart diseases, osteoporosis, diabetes, and dementia influencing women’s social relationships and overall quality of life and longevity. Women’s reproductive aging, healthy aging and gender equality are therefore inextricably linked, yet female reproductive aging remains an understudied topic.
There is a potential for Hormone Replacement Therapy(HRT) to relieve these phenotypes, but we can only get the full effect if the treatment is started on time. If HRT is given after the menopause transition, the patient has already lost a lot of estrogen receptors and will not be able to respond to estrogen as before. The problem is that currently menopause is diagnosed retrospectively, and the HRT administration is not optimal. In the UK, timely treatment of perimenopause could save the NHS over ÂŁ0.5 billion. A validated prognostic biomarker that would monitor the effectiveness of the personalized therapy, therefore, has a game-changing potential for the menopausal care pathway and could revolutionize the management of female health and aging.

11 million women in the UK alone are in an age of peri(menopause) and 8.8 million experience symptoms. They spend $20 000 in the span of 4-10 years on the menopause journey, including doctor visits, treatments, and other wellness products. Hence the TAM of this project is estimated to be $17.5 billion, with a SAM of $11 billion.

Specification

MenoAge is designed to be a novel biomarker for monitoring highly personalised approach to HRT benefits vs. risks of ongoing therapy, in connection to ageing and long-term health outcomes. It is intended to replace the currently inadequate hormone tests for perimenopause detection and assess the effectiveness of HRT on woman´s healthy lifespan. The retrospective cohort study conducted from 1984-2017 on 105,200 healthy UK women taking HRT, with an average follow- up of 13 years, found a 9-14% reduction in overall mortality for HRT users resulting in longer and healthier lifespan. MenoAge will thus represent a powerful, game-changing, and cost- effective tool aimed at improving female reproductive health and, consequently, supporting woman´s longevity.
They propose immunoglobulin G (IgG) glycans as a biomarker of perimenopause onset, and a safe and effective hormonal replacement therapy determination for monitoring of healthy female aging. IgG is a molecule involved in multiple functions of our immune system, one of them being the regulation of the overall immune activation threshold and inflammation level. As a part of the inflammaging process, IgG glycan composition changes towards more inflammatory as we age, with women showcasing a pronounced stepwise decline at menopause, indicating this as a “rapid aging” period. Accordingly, a study on close to 2000 women found that IgG glycosylation pattern “ages” at a higher rate during perimenopause. Most importantly, estrogen supplementation can entirely prevent inflammatory changes of IgG glycome caused by chemically induced menopause.

Project Lead: Who is leading this project? If approved, is that person willing to take on the Team role of lead for the project’s duration? Please mention their Discord username(s) here.

*Team: Prof Gordan Lauc, project lead, glauc@genos.hr (founder of Genos research labs, Gordan is the inventor of the GlycanAge test and company CSO)

Dr Julija Jurić, lead scientist, jjuric@genos.hr (employed with Genos for 7+ years)

Dr Marija Pezer, lead scientists, mpezer@genos.hr (employed with Genos for 7+ years)

Dr Frano Vuckovic, lead biostatistician, fvuckovic@genos.hr (employed with Genos for 7+ years)

Dr Louise Newson, principal investigator, louise.newson@newsonhealth.co.uk (research collaborator for 2+ years)

Dr Felix Agakov, AI and machine learning, felix@pharmaticsltd.com (collaborator for over 10+ years)

Dr Samir Khan, health economics and market access, samkhanicgeb@gmail.com (Market access consultant at GlycanAge for 1.5 years)

Nikolina Lauc, commercial director, nikolina@glycanage.com (CEO at GlycanAge for 2+ years)

Zorrie Dimitrova, operations manager, zorrie@glycanage.com (Operations manager at GlycanAge for 4+ years)

Description: Describe in a few short sentences what this project is about.

Reviews

In progress

Highlights

  • Very Strong Team of Scientists, Clinicians and Entrepreneurs
  • Produces revenue in the near-term
  • Large and growing Market with an unmet need
  • First encouraging data in humans

Risks

  • testing of product still in pre-clinical phase

Longevity WG scientific evaluation digest:

X/5 reviewers have expressed a vote in support of this assessment . Here is the digest:

Quantitative reviews:

Brief qualitative review summaries:

Implementation

Success Metrics: List out expected outcomes/goals for the community if you achieve the project goal. What does the project aim to accomplish? How do we know if we’ve solved this problem?

Patients need to be enrolled and samples collected consistently with timeline described below. When the samples’ glycome is analysed, the result would be compared to clinician reports, questionnaires, and patients’ symptoms to see how well they match. This is both in the case for perimenopause-menopause transition, as well as HRT start and patients’ response to it. If results are promising, the product will generate revenue quickly, starting to sell in private clinics and later on direct to consumers.

Timeline: Define a timeline for how long you think this project will take. What are key milestones you will focus on?

Following all applicable ethical guidelines, and aiming at ethnic and socio-demographic variability, we will recruit 100 perimenopausal women from among the waiting list of Newson Health Menopause and Wellbeing Clinic – and follow them up for up to 2 years from the initial visit. Each patient will complete at least 3 assessment visits at 6-12 months intervals. Patients will complete a menopause symptom questionnaire and a quality-of-life questionnaire at each visit. Hormone blood tests (oestradiol, testosterone, and SHBG levels) will be undertaken as clinically indicated. They will be given appropriate hormone replacement therapy, which will include oestradiol, according to their symptoms and health. Their management of perimenopause will be according to the national and international guidance on the management of perimenopause and menopause. The types of hormonal replacement therapy administered will be in line with guidance from the National Institute for Health and Care Excellence (NICE), according to each women’s clinical needs. Dried blood spots will be collected every month for IgG glycosylation analysis: at each visit and, additionally at home by self-test kits.

Budget: What is the expected budget, and how will this budget be used and distributed among the team.

Clinicians $100,000
Project team $50,000
800 IgG glycome analysis: sets (at $7), profiling analysis (at $60 subsidised price). Hormones biochemical blood tests (at $60) blood collection (at $30) $90,000*
Shipping costs, Other costs, Overhead $10,000

Supporting Documents

Application form: Sign in - Airtable

MenoAge Community Call with Nikolina Lauc and Dr. Louise Newson:

  • Agree
  • Agree with revisions (please comment)
  • Disagree

0 voters

Thanks - was able to listen in to the presentation today.

My preference is fund novel therapeutics so I am a bit biased. With this lens a diagnostic for an off patent product is not attractive to me. I tired to probe a bit on the call if there would be interest in the biomarker kit from manufacturers of innovative women’s health products as a way to enhance sales of their products, but it did not appear this would be the case, my understanding is that the biomarker is specific for HRT. (pls correct me if I am wrong!)

If one believes there is a significant market for the diagnostic AND MOST IMPORTANTLY it will be reimbursed by payors they may have potential for a valuable product.

I am not familiar with the diagnostic development pathway, would be very interested to hear someone with experience chime in - the key really if you want to vote yes here is to be convinced there is a path forward for reimbursement. Without that this product would face challenging commercialization PoS.

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