Lyndra's Pipeline
Lyndra's Pipeline

Making Daily Pills A Thing Of The Past

Lyndra is pioneering long-acting oral treatments that last a week or longer, which are designed to optimize the way medicine is delivered and simplify people’s lives. Lyndra is focused on therapeutic areas where long-acting oral treatments can have a significant positive impact.

Oral Drug Delivery Pipeline

Lyndra’s LYNX™ drug delivery platform has the potential for broad applicability across multiple therapeutic areas – including approved drugs and those currently in development. That’s why Lyndra is focused on some of the biggest challenges in healthcare.

Therapeutic Area Program Disease Preclinical Phase 1 Phase 2 Pivotal Partner
Wholly-Owned
Psychiatry Risperidone
LYN-005
Schizophrenia/Bipolar
1 Disorder
lyndra therapeutics transparent logo
Psychiatry Aripiprazole
LYN-006
Psychiatric Conditions
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Cardiometabolic Diseases Dapaglifozin
LYN-045
Diabetes
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Cardiometabolic Diseases Rosuvastatin
LYN-047
Dyslipidemia
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Partner Driven
Opioid Use Disorder Levomethadone
LYN-014
Opioid Use Disorder
Fast Track Designation
NIH transparent logo
Opioid Use Disorder Buprenorphine
LYN-013
Opioid Use Disorder
NIH transparent logo
Women's Health Monthly Oral Contraception
LYN-064
Pregnancy Prevention
bill and melinda gates foundation transparent logo
Infectious Diseases BiWeekly Ivermectin
LYN-163
Malaria Eradication
bill and melinda gates foundation transparent logo
Infectious Diseases Undisclosed HIV
gilead NIH transparent logo

Weekly

Current

Next 12 months

CNS Conditions

elderly woman looking out the window holding a coffee mug

Schizophrenia and Bipolar 1 Disorder

Schizophrenia and bipolar 1 disorder are mental health conditions that affect how a person thinks, feels and behaves, often impacting their concentration, relationships and ability to carry out day-to-day tasks. While many effective treatments exist, people living with these conditions often struggle with medication adherence, which in turn leads to many negative health outcomes. A stable and fulfilling life for people living with schizophrenia and bipolar 1 disorder is possible with consistent medication and support. By dramatically reducing dosing frequency, Lyndra’s long-acting oral therapies have the potential to increase adherence, prevent relapses and improve outcomes, while also freeing people from the burden of daily pills and simplifying their lives.

~ 1 M
Americans in treatment for schizophrenia1
~ 7 M
Past year prevalence of bipolar disorder in US adults 18 and over 2

Global & Public Health

Lyndra is reinventing medicine for a healthier world with the help of its partners and with funding support from organizations including the Bill & Melinda Gates Foundation, the National Institutes of Health and others. Lyndra’s global and public health pipeline focuses on areas where reduced dosing frequency would provide significant clinical benefits to patients, caregivers and society, including malaria eradication, oral contraception and medication-assisted treatment for opioid use disorder.

Cardiovascular and Cardiometabolic Diseases

Lyndra is developing oral weekly rosuvastatin (LYN-047) for people living with dyslipidemia, a major risk factor for cardiovascular disease, and oral weekly dapagliflozin (LYN-045) for the treatment of people living with diabetes. More than ~130 million adults in the US have lipid abnormalities related to high cholesterol6, while more than ~13% of the US adult population, or around ~35M people, live with diabetes.7 People living with these conditions often have multiple prescribed medicines, which increases the likelihood that they will struggle with medication adherence. Lyndra’s LYNX™ drug delivery platform could reduce this pill burden, potentially increasing adherence, improving health outcomes and reducing overall healthcare costs.
# 1
Cardiovascular disease is the leading cause of death in the United States.3
A lack of medication adherence is a significant driver of negative outcomes as ~40-50% of people living with diabetes or taking oral daily cholesterol-lowering medications admit struggling to take their medicines as prescribed.4,5

Opioid Use
Disorder

Lyndra is developing oral weekly levomethadone (LYN-014) for the maintenance treatment of opioid use disorder, with support from the National Institutes of Health’s National Institute on Drug Abuse (NIDA). Opioid use disorder is a problematic pattern of opioid use leading to clinically significant impairment or distress. People living with opioid use disorder benefit from medications for opioid use disorder, but only an estimated ~11% receive them.8 An oral weekly treatment option could free people from the need for daily dosing and help them get their lives back on track. The oral weekly levomethadone (LYN-014) program has received Fast Track designation from the FDA for this indication.
~ 70000
US overdose deaths from opioids (12-month period ending in September 2021)
CDC’s National Center for Health Statistics indicates an increase in opioid overdose deaths from the same period the year before.9

Malaria
Eradication

Lyndra has received funding from the Bill & Melinda Gates Foundation to develop oral biweekly ivermectin (LYN-163) as a tool to fight malaria. Malaria is a life-threatening disease caused by parasites transmitted through the bites of infected mosquitoes. Ivermectin has shown promise as a complementary tool that could reduce incidence and prevalence of malaria.10 Lyndra’s oral biweekly treatment could lead to dramatically reduced malaria transmission, providing a new malaria control tool.
~ 626000
Preventable global malaria deaths in 2020
The WHO African Region is the location for ~96% of malaria deaths.11

Pregnancy
Prevention

Lyndra has received funding from the Bill & Melinda Gates Foundation to develop an oral monthly contraceptive (LYN-064). Women and girls worldwide have access to better health, more educational opportunities, greater financial stability and less gender disparity when they have access to modern contraceptives to make informed family planning choices. Additionally, the Gates Foundation found that meeting the need for contraception and maternal and newborn healthcare would cost ~$600 million less than only meeting the need for maternal and newborn healthcare.12
~ 190 M
Women in low- and middle-income countries who want but don’t have modern contraception
Many women in low- and middle-income countries want access to reliable family planning. Still, about ~200 million aren’t using a modern method of contraception to facilitate their choice due to issues with both access and satisfaction.13
lab technician looking at pill
Partner with Lyndra

There are opportunities for partnership on these and other programs, including programs for which Lyndra has Phase 1 clinical data (i.e., Alzheimer’s disease, type 2 diabetes, dyslipidemia). Please contact Lyndra to connect on partnership opportunities.

Lynx™ Drug
Delivery Platform

A potential major advance in oral drug delivery

lyndra therapeutic pills on hexagon background

Lyndra’s LYNX™ drug delivery platform is modular and has the potential for broad applicability across multiple therapeutic areas – including approved drugs and those currently in development.

1. National Institute of Mental Health, “Schizophrenia,” https://www.nimh.nih.gov/health/statistics/schizophrenia, accessed January 4, 2022.

2. National Association of Mental Illness, “Bipolar Disorder,” https://www.nami.org/About-Mental-Illness/Mental-Health-Conditions/Bipolar-Disorder, accessed January 4, 2022.

3. National Center for Chronic Disease Prevention and Health Promotion, Division for Heart Disease and Stroke Prevention. (2022). Heart disease facts. Accessed 10/13/22 at https://www.cdc.gov/heartdisease/facts.htm#:~:text=Heart%20disease%20is%20the%20leading,groups%20in%20the%20United%20States.&text=One%20person%20dies%20every%2034,United%20States%20from%20cardiovascular%20disease.

4. Ferdinand, K. C., Senatore, F. F., Clayton-Jeter, H., Cryer, D. R., Lewin, J. C., Nasser, S. A., Fiuzat, M., & Califf, R. M. (2017). Improving medication adherence in cardiometabolic disease. Journal of the American College of Cardiology, 69(4), 437–451. https://doi.org/10.1016/j.jacc.2016.11.034

5. Gupta, P., Patel, P., Štrauch, B., Lai, F. Y., Akbarov, A., Marešová, V., White, C. M. J., Petrák, O., Gulsin, G. S., Patel, V., Rosa, J., Cole, R., Zelinka, T., Holaj, R., Kinnell, A., Smith, P. R., Thompson, J. R., Squire, I., Widimský, J., … Tomaszewski, M. (2017). Risk factors for nonadherence to antihypertensive treatment. Hypertension, 69(6), 1113–1120. https://doi.org/10.1161/hypertensionaha.116.08729

6. Tóth, P. P., Potter, D., & Ming, E. E. (2012). Prevalence of lipid abnormalities in the United States: the National Health and Nutrition Examination Survey 2003-2006. Journal of clinical lipidology, 6(4), 325–330. https://doi.org/10.1016/j.jacl.2012.05.002

7. U.S. Department of Health and Human Services, Center for Disease Control and Prevention. (n.d.). National Diabetes Statistics Report 2020. estimates of diabetes and its … Retrieved October 14, 2022, from https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

8. American Psychiatric Association, (2013), Diagnostic and statistical manual of mental disorders (5th ed.), https://doi.org/10.1176/appi.books.9780890425596.

9. Substance Abuse and Mental Health Services Administration. (2021). Key substance use and mental health indicators in the United States: Results from the 2020 National Survey on Drug Use and Health (HHS Publication No. PEP21-07-01-003, NSDUH Series H-56). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. https://www.samhsa.gov/data/, accessed March 8, 2022.

10. CDC, National Center for Health Statistics, Office of Communication, “Provisional Drug Overdose Death Counts” Centers for Disease Control and Prevention, https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm, accessed March 7, 2022.

11. Slater, H. C., Foy, B. D., Kobylinski, K., Chaccour, C., Watson, O. J., Hellewell, J., Smit, M. R. (2020). Ivermectin as a novel complementary malaria control tool to reduce incidence and prevalence: A modeling study. The Lancet Infectious Diseases, 20(4), 498-508. doi:10.1016/s1473-3099(19)30633-4

12. World Health Organization, “Malaria,” https://www.who.int/news-room/fact-sheets/detail/malaria, accessed January 18, 2022.

13. The Bill & Melinda Gates Foundation, “Family Planning,” https://www.gatesfoundation.org/our-work/programs/global-development/family-planning, accessed January 18, 2022.