Lyndra Therapeutics First Clinical Trial Participants Dosing in a Biweekly Study Oral Ivermectin (LYN-163) as a Tool in the Fight to Eliminate Malaria

First ever trial marks Presentation of the clinical study Two weeks of drugs in one oral dose

Funded by a grant from the Bill & Melinda Gates Foundation, Lindra He answers the call of the World Health Organization to investigate the drug ivermectin as a A new strategy for malaria eradication

WATERTOWN, MA–(BUSINESS WIRE)– Lindra Therapeutics, a clinical-stage biopharmaceutical company making daily pills a thing of the past, announced today that it has given the first participant in its Phase 1 clinical trial a biweekly oral ivermectin screening (LYN-163) To combat malaria.

Lyndra Linux™ A drug delivery platform makes oral ivermectin possible. In combination with current malaria control strategies, WHO believes that ivermectin, an antiparasitic drug, may provide a valuable tool in the fight to eliminate malaria in endemic communities.1 By giving a fixed dose of the drug for two weeks with a single oral administration, biweekly oral ivermectin may reduce the rate of malaria transmission, thus providing protection for the entire community. Lindra has received funding from the Bill & Melinda Gates Foundation to develop and test oral ivermectin every two weeks as part of the foundation’s strategic goal to achieve a malaria-free world.

Dr. said. Richard Scranton, chief medical officer of Lindra Therapeutics. “The two-week oral dosing is a vital step toward providing drugs that may help rid the world of malaria and serve as a model for future long-acting oral medications for other critical public and global health needs.”

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

Listed on the World Health Organization’s List of Essential Medicines, ivermectin has been approved for human use since 1987 to treat a variety of parasitic diseases. in the laboratory and clinical studies, as well as modeling based on these studies,3 He explains that ivermectin may help reduce the spread of malaria by killing mosquitoes that ingest blood containing target levels of the drug.4

Regina Rabinovich, ExxonMobil malaria researcher at Harvard University and director of the Elimination Malaria 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 in killing the mosquitoes that spread malaria. An easy-to-administer, long-acting oral formula can help protect entire communities. If these strategies are effective, they can change course of malaria control and making eradication a feasible goal.”

The commencement of this phase I clinical trial of orally administered biweekly ivermectin is just one evidence of Lyndra’s commitment to developing innovative solutions to some of healthcare’s most vexing challenges through the game-changing LYNX drug delivery platform. Pivotal trials of Lindra’s main asset, weekly oral risperidone (LYN-005), are scheduled to begin in 2022 and this Phase 1a clinical trial of levomethadone (LYN-014) from Lindra for the treatment of opioid use disorder is scheduled to begin. general.

Oral biweekly ivermectin (LYN-163)

Lyndra’s long-acting oral 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 target levels of ivermectin; Therefore, the World Health Organization (WHO) called for a study of ivermectin to combat malaria. Oral biweekly ivermectin may help eliminate malaria at adult doses in malaria-endemic areas, by maintaining a stable plasma concentration of ivermectin for two weeks after a single dose, giving it the ability to reduce transmission and incidence of infection disease throughout the entire community. Combined with current malaria control strategies, oral ivermectin taken every two weeks could help turn the tide in the global battle 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, producing drugs that last a week or more in oral dosage form. A key aspect of the platform is the ability to consistently deliver medication, minimizing peak levels and dips in drug levels compared to daily medication. Based on technology invented at Langer Lab, the LYNX platform has seen rapid progress since 2015 through preclinical and early human studies and achieved proof of concept for the platform and key asset in a recently completed Phase II study. The LYNX platform is modular and scalable and can include virtually any oral therapies – including approved drugs and those currently in development – ​​providing the potential for increased adherence and improved health outcomes, while freeing people from the burden of daily pills and simplifying their lives.

About Lindra Therapeutics

Lyndra Therapeutics is a clinical-stage biopharmaceutical company that has pioneered long-acting oral therapies. Lindra is focused on commercializing treatments in disorders of the central nervous system (CNS), which could benefit most from significantly lower frequency of doses. Lindra’s flagship product, oral weekly risperidone (LYN-005), is being developed to treat people with schizophrenia and bipolar 1 disorder. The company is also committed to advancing its platform to address global public health and health challenges, with treatments that include weekly oral levomethadone and weekly oral buprenorphine for bipolar disorder. Use of opioids, the oral monthly pill and oral ivermectin every two weeks to eliminate malaria. Since Lyndra’s founding, the company’s partners have included the Bill & Melinda Gates Foundation, the National Institutes of Health, AbbVie and Gilead Sciences, Inc. Lyndra is headquartered in Watertown, Massachusetts 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 to combat malaria transmission. 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. (second abbreviation). Fact sheet on malaria. https://www.who.int/news-room/fact-sheets/detail/malaria

3 World Health Organization: Global Malaria Programme. (2017). WHO Prefer Properties: endectocide to combat malaria transmission, 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, FO, Walker, P., Ghani, AC, & Smit, M.R (2020). Ivermectin as a new complementary tool for malaria control to reduce incidence and prevalence: a modeling study. scalpel; Infectious Diseases, 20(4), 498–508. https://doi.org/10.1016/S1473-3099(19)30633-4

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