- Oxolife's OXO-001 is a safe, first-in-class drug designed to
improve the odds of an embryo embedding by making the endometrium
more conducive to implantation
- Ongoing pregnancy rate was 10.6 percentage points higher in
women who received OXO-001 than in those who received a placebo
(46.3% for OXO-001 vs. 35.7% for placebo)
- Live birth rate was 6.9 percentage points higher (42.6% vs
for OXO-001 vs. 35.7% for placebo)
- Results – from proof-of-concept Phase 2 double-blinded,
randomised controlled trial in women up to 40 years of age who used
donor eggs – to be published in Human Reproduction
- Oxolife plans pivotal Phase 3 study – to include women using
own eggs
BARCELONA, Spain, July 8, 2024 /PRNewswire/ -- Oxolife, the female
fertility biotech focused on enhancing embryo implantation in women
undergoing assisted reproductive technology (ART) fertility
treatment, today presents successful phase 2 clinical data on its
fertility pill OXO-001 at the European Society of Human
Reproduction and Embryology (ESHRE) 40th Annual Meeting held in
Amsterdam.
OXO-001 is a first-in-class, non-hormonal drug that acts
directly on the endometrium – the inner lining of the uterus – to
make it more conducive to embryo implantation. Failure of viable
embryos to implant is a major reason why so many rounds of in-vitro
fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) do
not result in pregnancy, and consequently a major cause of
heartache among those trying for a baby. Taken twice daily,
starting one menstrual cycle before embryo transfer and then for
five weeks after transfer, OXO-001 is designed to reduce that
distressing possibility.
Today, Oxolife is presenting highly promising new data at ESHRE
from its proof-of-concept Phase 2 double-blinded, randomised
controlled trial of OXO-001, in which it was tested against a
placebo pill.
An exploratory subset analysing 96 women up to 40 years of age,
who all underwent single embryo transfer using donor eggs, found
OXO-001 resulted in a large and statistically significant
improvement in the biochemical pregnancy rate (early detection of
pregnancy). While 52.4% of those who received the placebo (22 of
42) had a biochemically confirmed pregnancy, among those who
received OXO-001 the rate was 75.9% (41 of 54).
There were also clinically meaningful improvements in:
- the clinically confirmed pregnancy rate (fetal heartbeat five
weeks after embryo transfer) – 50.0% for OXO-001 vs. 35.7% for
placebo;
- the ongoing pregnancy rate (10 weeks post-embryo transfer) –
46.3% vs. 35.7%;
- the live birth rate – 42.6% for OXO-001 vs. 35.7% for
placebo.
The Phase 2 trial was not powered to confirm that the
differences for these outcomes were statistically significant.
However, the data generated strongly supports advancement to Phase
3 confirmatory trial. Results of the Phase 2 trial are due to
be published soon in the highly-regarded journal Human
Reproduction.
Agnès Arbat, Chief Executive Officer, Oxolife, said:
"Most rounds of IVF or ICSI still end in failure – many, because
a viable embryo does not implant. A simple-to-take pill that
materially improves the chance of success would therefore be of
huge benefit to those who want a baby. This proof-of-concept phase
2 study shows that hope is now a step closer. Physicians and
patients tell us that they consider a five percentage-point
improvement in the ongoing pregnancy rate after IVF / ICSI to be
clinically meaningful, so to achieve double that is amazing. This
study was purposefully designed to include only women who used
donor eggs so it could single out the true effect of OXO-001 on the
endometrium. However, we believe OXO-001 has the potential to work
equally well in those using their own eggs, and we are already
planning a pivotal Phase 3 clinical trial in this more extensive
group to support product registration."
Professor Dr Karen Sermon,
Chair of ESHRE, who was not involved in the study,
commented: "Despite continuous developments in ovarian
stimulation, embryo manipulation and culture, improving live birth
rates in medically assisted reproduction has been incremental at
best. A jump of nearly seven percentage points is very good news
for our patients, and hopefully, this can be confirmed in larger
patient groups."
OXO-001 works directly on the endometrium to encourage the
embryo to stop rolling, to invade endometrial tissue, and to
complete implantation. Extensive preclinical testing, plus clinical
testing in 300 women to date, has shown it has an excellent safety
profile. It is rapidly absorbed and expelled by the woman's body
within 24 hours after administration. In follow-up of babies six
months after birth, all demonstrated normal development with no
differences compared to placebo.
About one in six women of childbearing age has trouble
conceiving[1], while use of fertility treatment is increasing
worldwide as couples delay childbearing. Latest figures compiled by
ESHRE[2] indicate around four million ART cycles are now performed
globally each year, resulting in about one million babies. However,
recurrent embryo implantation failure remains a significant
challenge[3].
About Oxolife
Oxolife is a specialist biotech focused on female fertility. Its
lead compound is an easy to administer, non-hormonal, oral pill
that addresses two indications; its lead programme is embryo
implantation, a major factor in improving pregnancy success rates;
a secondary indication is Polycystic Ovary Syndrome ("PCOS"), where
it recovers ovulation and fertility. Its lead indication in embryo
implantation has completed phase 2 studies, while its PCOS
indication is on track for IND/ CTA application in H1 2025. With
the global infertility market growing at 4.5% a year, due to later
pregnancies, obesity, smoking and alcohol, 76m women a year are affected, with an expected
market value of $45.4bn in 2029.
Oxolife is currently fundraising to accelerate the progress of
OXO-001, its lead programme, through the clinic and is also
exploring potential partnerships to bring the benefits of OXO-001
to patients as rapidly as possible. https://oxolife.com/
About the European Society of Human Reproduction and
Embryology
The main aim of ESHRE is to promote interest in infertility care
and to aim for a holistic understanding of reproductive biology and
medicine. ESHRE collaborates world-wide and advocates universal
improvements in scientific research, encourages and evaluates new
developments in the field, and fosters harmonisation in clinical
practice. It also provides guidance to enhance effectiveness,
safety and quality assurance in clinical and laboratory procedures,
psychosocial care, and promotes ethical practice. ESHRE also
fosters prevention of infertility and related educational
programmes and promotes reproductive rights regardless of the
individual's background. ESHRE's activities include teaching,
training, professional accreditations, mentoring and career
planning for junior professionals, as well as developing and
maintaining data registries. It also facilitates and disseminates
research in human reproduction and embryology to the general
public, scientists, clinicians, allied personnel, and patient
associations. https://www.eshre.eu
[1] https://www.cdc.gov/nchs/fastats/infertility.htm
[2] ESHRE ART fact sheet 10, November 2023
[3] Cimadomo, D., Craciunas, L., Vermeulen, N., Vomstein,
K., & Toth, B. (2020). Definition, diagnostic and therapeutic
options in recurrent implantation failure: An international survey
of clinicians and embryologists. Human Reproduction, 36(2),
305–317. https://doi.org/10.1093/humrep/deaa317
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