WATERTOWN, Mass.--(BUSINESS WIRE)-Lyndra Therapeutics, a clinical-stage biopharmaceutical company working to make daily pills a thing of the past, today announced it has dosed the first participant in its Phase 1 clinical trial investigating oral biweekly ivermectin (LYN-163) to fight malaria.

Lyndra’s LYNX™ drug delivery platform makes oral biweekly ivermectin possible. Combined with existing malaria control strategies, the World Health Organization (WHO) believes that ivermectin, an antiparasitic medicine, may provide a valuable tool in the fight to eradicate malaria in communities where the disease is endemic.¹ By delivering a steady dose of drug for two weeks with a single oral administration, oral biweekly ivermectin may reduce the rate of malaria transmission, thereby providing protection for an entire community. Lyndra has received funding from the Bill & Melinda Gates Foundation to develop and test oral biweekly ivermectin as part of the foundation’s strategic goal to achieve a world free of malaria.

“The initiation of this Phase 1 trial marks the first time a single oral dose is able to deliver drug steadily for two weeks – another milestone in Lyndra’s efforts to reduce the dosing frequency of oral medicines with our LYNX drug delivery platform,” said Dr. Richard Scranton, Chief Medical Officer of Lyndra Therapeutics. “Two-week oral dosing is a vital step toward providing medicine that may help rid the world of malaria and serve as a model for future long-acting oral medicines for other critical global and public health needs.”

Additional investment and innovations in malaria eradication strategies are needed, with an estimated 241 million cases of malaria and ~627,000 malaria-related deaths worldwide in 2020. Approximately 95% of cases and 96% of deaths are in the WHO African Region.²

Included on the WHO’s List of Essential Medicines, ivermectin has been approved for human use since 1987 to treat a variety of parasitic diseases. In-vitro and clinical studies, as well as modeling based on these studies,³ shows that ivermectin may help reduce the spread of malaria by killing mosquitoes that ingest blood containing targeted levels of the drug.⁴

“Despite the fact that malaria is preventable and treatable, it remains one of our most serious global health problems,” said Dr. N. Regina Rabinovich, ExxonMobil Malaria Scholar in Residence at Harvard University and Director of the Malaria Elimination Initiative at the Barcelona Institute for Global Health (ISGlobal). “Our current malaria control strategies are failing; new vector control strategies are needed. Ivermectin has shown promise to kill mosquitoes that spread malaria. A long-acting oral formulation that is easy to administer could help provide protection to entire communities. If these strategies are effective, they can change the trajectory of malaria control and make eradication a feasible goal.”

The initiation of this Phase 1 clinical trial for oral biweekly ivermectin is just one demonstration of Lyndra’s commitment to developing innovative solutions to some of the most vexing challenges in healthcare with its game-changing LYNX drug delivery platform. Pivotal trials for Lyndra’s lead asset, oral weekly risperidone (LYN-005), are planned to initiate in 2022 and a Phase 1a clinical trial for Lyndra’s oral weekly levomethadone (LYN-014) for the treatment of opioid use disorder is scheduled to begin this year.

About Oral Biweekly Ivermectin (LYN-163)

Lyndra’s investigational long-acting oral biweekly ivermectin (LYN-163), enabled by Lyndra’s LYNX™ drug delivery platform, is being studied as a tool in the fight to eradicate malaria. Malaria-carrying mosquitoes die if they ingest blood containing targeted levels of ivermectin; therefore, the World Health Organization (WHO) has called for the study of ivermectin for malaria control. Oral biweekly ivermectin may help to eliminate malaria when dosed to adults in areas where malaria is endemic, by maintaining a steady plasma concentration of ivermectin for two weeks after a single dose, giving it the potential to reduce transmission and disease incidence throughout an entire community. Combined with existing malaria control strategies, oral biweekly ivermectin could help turn the tide in the global fight against the disease.

Lyndra’s LYNX™ Drug Delivery Platform

The LYNX™ drug delivery platform is the most significant advance in oral drug delivery in decades, creating medicines that last for a week or longer in an oral dosage form. A key aspect of the platform is the ability to deliver the drug consistently, minimizing peaks and troughs of drug levels compared to daily medicine. Based on technology invented in the Langer Lab, the LYNX platform has progressed rapidly since 2015 through preclinical and early human studies and achieved proof of concept of the platform and lead asset in a recently completed Phase 2 study. The LYNX platform is modular and scalable and can incorporate virtually any oral therapies – including approved drugs and those currently in development – offering the potential to increase adherence and improve health outcomes, while also freeing people from the burden of daily pills and simplifying their lives.

About Lyndra Therapeutics

Lyndra Therapeutics is a clinical-stage biopharmaceutical company pioneering long-acting oral therapies. Lyndra is focused on commercializing therapies in central nervous system (CNS) disorders, which would most benefit from dramatically reduced dosing frequency. Lyndra’s lead product candidate, oral weekly risperidone (LYN-005), is being developed for the treatment of people living with schizophrenia and bipolar 1 disorder. The company is also committed to advancing its platform to tackle major public health and global health challenges, with therapies that include oral weekly levomethadone and oral weekly buprenorphine for opioid use disorder, a monthly oral contraception pill and oral biweekly ivermectin for malaria eradication. Since the founding of Lyndra, the company’s partners have included the Bill & Melinda Gates Foundation, the NIH, AbbVie and Gilead Sciences, Inc. Lyndra is headquartered in Watertown, MA and has a state-of-the-art GMP manufacturing facility in Lexington, MA. For more information, visit https://lyndra.com.

¹ World Health Organization. (2016). Ivermectin for malaria transmission control. https://cdn.who.int/media/docs/default-source/malaria/mpac-documentation/mpac-sept2016-invermectin-session9.pdf?sfvrsn=170018d7_7&download=true
² World Health Organization. (n.d.). Fact sheet about malaria. https://www.who.int/news-room/fact-sheets/detail/malaria
³ World Health Organization: Global Malaria Programme. (2017). WHO preferred characteristics: endectocide for malaria transmission control, Information note. World Health Organization.
⁴ Slater, H. C., Foy, B. D., Kobylinski, K., Chaccour, C., Watson, O. J., Hellewell, J., Aljayyoussi, G., Bousema, T., Burrows, J., D’Alessandro, U., Alout, H., Ter Kuile, F. O., Walker, P., Ghani, A. C., & Smit, M. R. (2020). Ivermectin as a novel complementary malaria control tool to reduce incidence and prevalence: a modelling study. The Lancet. Infectious diseases, 20(4), 498-508. https://doi.org/10.1016/S1473-3099(19)30633-4

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