Bill & Melinda Gates Foundation

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.

WATERTOWN, Mass.--(BUSINESS WIRE)-- Lyndra Therapeutics today announced that its LYNX™ drug delivery platform was named the winner of the Fierce Life Sciences Innovation Awards 2022 award in the Drug Delivery Technology category. “We are thrilled at this recognition of the LYNX™ platform, which we are using to pioneer long-acting oral medicines,” said Dr. Patricia Hurter, CEO of Lyndra Therapeutics. “We have the chance to truly transform the experience of patients, delivering medicine in an optimal way and making it simpler and easier for them to be adherent. It is an honor to have the platform selected by the Fierce award judges in such a competitive category.” The Fierce Life Sciences Innovation Awards, produced by Fierce Biotech and Fierce Pharma, showcase outstanding innovations that are transforming the life sciences industry. The awards are judged on the ability of the applicant to demonstrate effectiveness, technical ingenuity, competitive advantage, financial impact and true innovation. The LYNX™ drug delivery platform harnesses more than 50 patented innovations in design, engineering and materials science to achieve dramatically reduced dosing frequency. The platform has the potential for broad applicability across multiple therapeutic areas – including approved drugs and those currently in development. Lyndra has formulated 24 therapies in the lab and achieved clinical proof of concept in 4 therapeutic areas. The company’s lead asset is oral weekly risperidone (LYN-005) for people living with schizophrenia and bipolar 1 disorder. Pivotal trials are planned to initiate in the coming months. Additional research is underway in cardiovascular and cardiometabolic diseases, opioid use disorder, malaria and oral contraception. Lyndra’s program investigating oral weekly levomethadone (LYN-014) for opioid use disorder has received Fast Track designation from the FDA. “Winners of the Fierce Life Sciences Innovation Awards represent those that champion innovation in the face of great competition,” said Rebecca Willumson, SVP & Publisher of Fierce Biotech and Fierce Pharma. “We are very proud of this year’s class and send our congratulations to all of the Innovation Award winners.” Lyndra’s LYNXTM Drug Delivery Platform The LYNX™ drug delivery platform is one of the most significant advances 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 its 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™ drug delivery platform has the potential for broad applicability across multiple therapeutic areas – including approved drugs and those currently in development. The LYNX™ drug delivery platform offers 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 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 has received funding from 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

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 pivotal clinical trial investigating oral weekly risperidone (LYN-005). Lyndra is developing LYN-005 to provide a new treatment option for patients living with schizophrenia, schizoaffective disorder and bipolar I disorder. Lyndra’s LYNX™ drug delivery platform is designed to enable a week-long dose of risperidone to be delivered in a single oral capsule. The oral daily form of risperidone is one of the most prescribed treatments for people living with schizophrenia and bipolar I disorder. “At Lyndra, our development pipeline focuses on health conditions where reducing the dosing frequency and delivering the drug more consistently could have a significant impact,” said Richard Scranton, M.D., M.P.H., Chief Medical Officer of Lyndra Therapeutics. “People living with schizophrenia and other serious mental health conditions need more patient-centric treatment options that can help address challenges like poor medication adherence and relapse.” “Clinicians involved in the trial are eager to see the impact that LYN-005, powered by the LYNX™ platform, may have on increasing medication adherence, reducing relapses and improving outcomes,” added Nayana Nagaraj, M.D., M.P.H., Ph.D., Senior Medical Director, Clinical Research at Lyndra Therapeutics. “We believe LYN-005 and other long-acting oral therapies powered by LYNX™ have the potential to improve therapeutic outcomes while simultaneously freeing people from the burden of taking daily medicines.” The oral weekly risperidone pivotal trial is a pharmacokinetic (PK) comparability study evaluating weekly doses of risperidone from LYN-005 that are equivalent to 2 and 6 milligrams of daily risperidone. This trial bridges to previously established safety and efficacy of immediate release (daily) risperidone. While antipsychotic medicines such as risperidone have been shown to control both positive and negative symptoms of schizophrenia, medication adherence is a major challenge for patients and a goal of clinical treatment. A recent survey of patients and caregivers demonstrated the challenges of daily medication regimens, with nearly 100% of respondents reporting moderate to severe challenges taking their medications as prescribed1. A review of the unmet needs and challenges in the treatment of patients living with schizophrenia noted that a lack of treatment or poor medication adherence can worsen disease symptoms, including triggering relapse2 -- further emphasizing the need for patient friendly treatment options as a priority for people living with schizophrenia. Currently, the only long-acting medicines available for schizophrenia require injections, but data show that they are used by a minority of patients. “Poor or partial adherence to prescribed medications remains a frequent cause of relapse and hospitalization in people living with schizophrenia,” said John M. Kane, M.D., professor, Department of Psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, and advisor to Lyndra. “The availability of a long-acting oral formulation would be a very welcome addition to our therapeutic armamentarium." The initiation of this clinical trial is a step toward bringing the promise of long-acting oral therapies to people living with mental health conditions and their caregivers, for whom an oral-weekly option may provide significant benefits. About Oral Weekly Risperidone (LYN-005) Oral weekly risperidone (LYN-005) is being developed for the treatment of people living with schizophrenia and bipolar I disorder. Oral weekly risperidone uses Lyndra’s innovative LYNX™ drug delivery platform to provide single weekly doses as an alternative to daily risperidone. Phase 2 data for oral weekly risperidone demonstrated that the active moiety quickly reached therapeutic levels in patients, provided sustained drug levels for repeated one-week dosing intervals, and reduced peak drug exposure. Oral weekly risperidone has the potential to be the first-ever long-acting oral therapy for the treatment of people with schizophrenia and bipolar 1 disorder. About Schizophrenia/Schizoaffective disorder Schizophrenia and schizoaffective disorder are serious, long-term mental health conditions that may make it difficult for people to think clearly, manage emotions and function in daily activities. Schizophrenia affects approximately 24 million people or 1 in 300 people (~0.32%) worldwide.3 Schizophrenia typically manifests as hallucinations, delusions and disorganized thoughts and behavior. Medication non-adherence, estimated to be around 50%,4 is the most common risk factor for relapse in patients with schizophrenia. Studies have shown that simpler, less frequent dosing can improve adherence and outcomes among those who are unable to comply with daily medication regimens. Today, the only long-acting formulations available are injectables, however, many patients prefer oral medications. Oral weekly risperidone (LYN-005), if approved, may provide a long-acting oral alternative that patients and caregivers prefer. Lyndra’s LYNX™ Drug Delivery Platform The LYNX™ drug delivery platform is one of the most significant advances 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 its 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 at MIT, 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 Phase 2 study. The LYNX™ drug delivery platform has the potential for broad applicability across multiple therapeutic areas – including approved drugs and those currently in development. The LYNX™ drug delivery platform offers 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’s initial focus is on developing therapies in central nervous system (CNS) disorders, which would 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 develop multiple oral therapeutics for a broad range of diseases including 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 has received funding from 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 .