Lyndra Therapeutics said today it has won a $13 million grant from the Bill and Melinda Gates Foundation toward development of a once-a-month oral contraceptive—the company’s first foray into women’s health therapies.

The Gates Foundation is awarding the grant through the Bill & Melinda Gates Family Planning program, created with the purpose of providing women in low- and middle-income countries with access to “high-quality” contraceptive information, services, and supplies.

“This grant is special because it extends our focus on meeting unmet therapeutic need into women’s health,” said Amy Schulman, CEO and co-founder of Lyndra Therapeutics.

Lyndra is working to develop a new once-monthly oral combination therapy designed to deliver a continuous dose of estrogen and progestin, the same drugs used in daily combined oral contraceptives. The development program is focused on demonstrating that once-monthly residence is achievable.

To that end, Lyndra said it will conduct a preclinical evaluation in collaboration with Routes2Results, a non-profit social and public health research organization and collective, to be paid for through additional funds from the Gates Foundation.

“We are proud to be part of the foundation’s effort to improve lives and ensure better health outcomes by making it easier to access and benefit from family planning,” Schulman added.

The Foundation cites statistics from the Guttmacher Institute showing that nearly 214 million women of reproductive age (15–49) in developing regions who wanted to avoid pregnancy were not using modern contraceptives as of 2017. Of the estimated 206 million pregnancies in developing regions in 2017, according to the Foundation, 43% were unintended, with care related to the pregnancies totaling $8.3 billion annually.

The contraceptive will apply Lyndra’s ultra-long-acting oral dosage form, for which the company last year trumpeted preliminary results from a pharmacokinetics (PK) study showing success in converting a once-daily therapy into a weekly dosage.

Star-shaped formulation

The oral dosage form is designed to deliver sustained, steady-state release of one or more drugs for up to a week or longer while temporarily residing in the stomach. Inside a familiar capsule is a star-shaped formulation with active pharmaceutical ingredients that are released consistently over time. The formulation, which is designed to open once inside the stomach, eventually exits safely via the gastrointestinal tract, like undigested food.

Lyndra asserts that a single, long-acting pill weekly can improve medication adherence and health outcomes compared with treatments taken daily or more often, while reducing burdens on individuals and their caregivers. In December, the company received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for intellectual property related to our ultra-long-acting dosage form—specifically, U.S. patent application No. 15/317,566, titled “Residence Structures and Related Methods.”

Separately, the Gates Foundation also awarded Lyndra a grant of undisclosed amount toward the development of ivermectin, a once-weekly drug designed to interrupt the vector transmission of malaria for up to 14 days by targeting mosquitoes that transmit the disease. The weekly dosage of the drug could boost the efficacy of mass drug administration and help eliminate malaria, according to Lyndra.

The Gates Foundation was among investors that participated in a $60 million Series B financing the company completed in February. Lyndra said proceeds from that financing will be used toward Phase II clinical trials, expansion of its Phase I pipeline, and manufacturing scale-up. Lyndra’s pipeline includes treatments in development for Alzheimer’s disease and schizophrenia, a weekly-or-longer duration HIV treatment being developed through a collaboration with Gilead Sciences, as well as candidates for transplant rejection and opioid use disorder.

In addition to the Gates Foundation, other participating investors include FUJIFILM Holdings America, Gilead Sciences, HOPU Investments, Invus, and Orient Life, and all investors in the company’s $23 million Series A financing completed in April 2017. That round was led by Polaris Partners and included Quark Venture and GF Securities, Yonghua Capital, Healthlink Capital, Partners Healthcare, Suffolk Equity, and other unnamed investors.

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