Lyndra Receives $13 Million from Gates Foundation to Develop Once-A-Month Oral Contraceptive



The Bill & Melinda Gates FoundationgrantedWatertown, Massachusetts-based Lyndra Therapeutics a $13 million grant to develop a once-a-month oral contraceptive. The grant is part of the Bill & Melinda Gates Family Planning program, whose goal is to provide access to high-quality contraceptive information, services and supplies to women in low- and middle-income countries.

“This grant is special because it extends our focus on meeting unmet therapeutic needs into women’s health,” stated Amy Schulman, co-founder and chief executive officer of Lyndra. “We are proud to be a part of the foundation’s efforts to improve lives and ensure better health outcomes by making it easier to access and benefit from family planning.”

The funds will be used to design and manufacture a combination therapy that provides a continuous dose of estrogen and progestin, the compounds used in daily combined oral contraceptives. The company’s development program is working to demonstrate that a once-monthly dose is achievable and will work in collaboration with Routes2Results, a non-profit social and public health research organization.

The Bill & Melinda Gates Foundation also recently provided Lyndra a grant to develop a long-acting malaria drug as well asinvested in the company’s recent Series B financing round. The financing round was in January 2019 and raised $60.9 million. Gilead Sciences was also an investor.

Lyndra’s technology is based on a star-shaped capsule. The six arms of the star unfold inside the patient’s stomach and slowly releases the drug over an extended period of time. The star remains in the stomach until all the arms break off and then is expelled from the body.

Earlier this month, Lyndraentered a partnership collaboration with Gilead Sciences to develop and market ultra-long-acting oral HIV therapies using Lyndra’s platform. Gilead paid $15 million upfront, with Gilead picking up exclusive rights to any product that comes out of the collaboration. In addition, Lyndra agreed not to work with other companies on HIV medications.

The Gates Foundation notes that as of 2017, almost 2014 million women between the ages of 15 and 49 in developing regions of the world don’t have access to modern contraceptives. They further note that of the 206 million pregnancies in the region in that year, 43% were unintended and the care related to the pregnancies totaled $8.3 billion annually.

The Lyndra technology was originally developed by Robert Langer at the Massachusetts Institute of Technology (MIT). The company’s most advanced drug candidate is a formulation of the generic version of Namenda (memantine hydrochloride) taken twice a day for Alzheimer’s disease. A November 2018 clinical trial showed that its once-weekly version was comparable to historical data of a once-daily, extended release formulation.

The company has six products in development for Alzheimer’s, schizophrenia, kidney transplant rejection, HIV, opioid use disorder and malaria.

It’s not clear yet if Lyndra will be able to develop an oral contraceptive that can be taken only once a month.

“They need to design the ability for the drug to be stable in the gastric juices, which is a high acidity environment, for a full month,” Patrick Kiser, a biomedical engineer and professor at Northwestern University told STAT. Kiser isn’t affiliated with Lyndra, but has received funding from the Gates Foundation. Another challenge is the pill Lyndra develops will have to travel through the digestive system at a specific time.



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