- Pre-clinical data in mice demonstrated 100% of those treated with SPERTILITY™ achieved live birth vs. 56% treated with standard of care
- Data supports advancement of Ohana’s lead clinical candidate, SPERTILITY, an ex vivo sperm enhancement treatment, for use in Assisted Reproductive Technology (ART)
- SPERTILITY is currently being evaluated in a randomized, controlled clinical trial (NCT04142112) in couples using IVF, with data anticipated in Q4 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Ohana Biosciences, a clinical-stage biotechnology company pioneering reproductive health through the industry’s first sperm biology platform, will present data from a preclinical study of their product candidate, SPERTILITY at the International IVF Initiative (i3) Webinar Series. The i3 session will take place Tuesday, September 15 at 3:00 p.m. EST. More details on the series can be found here. These findings were originally presented at the American Society of Andrology virtual poster session in June 2020.
SPERTILITY is an ex vivo sperm enhancement treatment that has the potential to result in higher quality embryos and improve pregnancy outcomes for anyone undergoing ART. SPERTILITY optimizes sperm metabolism to improve sperm function, mimicking what occurs as sperm travel through the female reproductive tract during natural conception. Ohana is currently conducting a randomized, controlled study (NCT04142112) across seven fertility centers in the U.S. to evaluate SPERTILITY. The study is designed to quantify the number of high-quality euploid embryos and evaluate pregnancy outcomes for people using IVF. Data from the study is anticipated by year-end.
“SPERTILITY has the potential to make a meaningful difference for people using Assisted Reproductive Technology to conceive. Based on the preclinical data generated to-date, we believe SPERTILITY could make each IVF or IUI treatment cycle more productive, increasing success rates and reducing the time it takes to have a healthy baby,” said Kathleen Seyb, Ph.D., Vice President of Research at Ohana Biosciences, who presented the data. “We look forward to sharing our work with professionals throughout the reproductive medicine community as part of the i3 Webinar Series as we build awareness around SPERTILITY and prepare for initial data from our ongoing clinical trial later this year. Sperm-based approaches have historically been understudied, and we’re excited to advance what could be the first sperm-focused advance in fertility treatment in nearly 30 years.”
As previously announced, in a non-clinical study semen samples were obtained from a total of 72 men. Of the 72, 48 were from couples seeking infertility treatment and 24 were healthy men. Investigators isolated sperm and processed half with the step-wise Ohana sperm enhancement treatment and the other half with the current standard of care, a commercially available sperm wash. In samples from the infertility treatment group, the percent of sperm that were categorized as hyperactive was significantly higher when processed with Ohana’s sperm enhancement treatment. The findings were similar for the samples obtained from healthy men. The study also found that Ohana’s treatment restored normal motility phenotype in sub-fertile human sperm, making it similar to sperm from healthy donors.
Sperm Hyperactivation and Pregnancy
The association between sperm hyperactivation and successful IVF in humans has been documented in medical literature. Based on Computer-Aided Sperm Analysis (CASA) of samples in 150 couples undergoing IVF, the same analysis used in the Ohana study, Donnelly and colleagues1 found an approximately two-fold increase, from 5% to 9%, in the median percent of hyperactive sperm in couples who achieved pregnancy compared to those who did not. Applying the same definition of hyperactivation used by Donnelly, sperm processed using Ohana’s sperm enhancement treatment had 17.5% hyperactivation, a percent hyperactivation that has a significant association with pregnancy in the Donnelly study.
In preclinical studies, the Ohana treatment significantly increased mouse fertilization and embryo development from total oocytes retrieved. In addition, there was a 1.5-fold increase in the number of embryos that developed from two-cell embryos and a higher live birth rate. In a mouse intrauterine insemination (IUI) model, the Ohana treatment was associated with a three-fold increase in pregnancy rates and a five-fold increase in live birth. Taken together, these data suggest that activating sperm using Ohana’s sperm enhancement treatment may not only improve sperm function and fertilization, but also embryo development, increasing pregnancy and live birth in both IVF and IUI in mice.
About Ohana Biosciences
At Ohana Biosciences, we work on pioneering reproductive health advances for all people through our industry-first platform of sperm-based technologies. We began with a vision to revolutionize global reproductive health and help all people create the healthy family they dream of – when they are ready. Today, we believe our unprecedented understanding of sperm biology coupled with our pioneering research will turn our vision into a reality. Through our platform, we are focused on fundamental components of reproductive health: fertility, pregnancy complications, inherited disease, developmental disorders, and non-hormonal contraception. By advancing research in fertility treatments, new technologies to reduce pregnancy complications, disease transmission, and developmental disorders, and enabling non-hormonal contraception, Ohana is dedicated to becoming a leader in reproductive health and offering life-changing options for people. Ohana was founded in 2016 by Flagship Pioneering and is based in Cambridge, Mass. For more information, please visit www.OhanaBio.com.
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1 Donnelly et al. In vitro fertilization and pregnancy rates: the influence of sperm motility and morphology on IVF outcome. Fertil Steril. 1998; Aug; 70(2):305-314.
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