Ultra-Long-Acting Oral Dosing is Achievable
Lyndra released clinical data in November 2018 demonstrating that its once-weekly dosage form can safely reside in the stomach with predictable pharmacokinetics. This was the first clinical study showing that it’s possible to convert a once-daily therapy into a weekly dosage. It demonstrated controlled, steady release of medication over an extended period, something no oral therapy had previously achieved. The pharmacokinetics data also showed that an ultra-long-acting oral dosage form has the potential to reduce drug side effects and improve efficacy.
Lyndra has continued to expand its Phase 1 pipeline, with more than 58 subjects dosed, with 50 whom have received the dosage form across 4 Phase I clinical studies to date.
- Advantages in systemic, non-systemic, and local target delivery due to continuous & steady delivery
- Possibility of reducing total dose while maintaining efficacy (non-inferiority)
- Reducing Cmax has the potential to, or could improve side effects
- Forgiveness if delayed administration
- Reduced healthcare costs through better pharmacology and measurable health outcomes
- Patient freedom from the burden of daily medications
- Adaptable for wide range of single agents and combinations
- Discreet user controlled administration
- Reduced pill burden
- Reduced caregiver burden
- Superior Pharmacology for existing Agents
- Loss of Exclusivity (LOE)
- Combination Products
- Local GI Delivery
- Non-systemic Delivery Enhanced Continuous Release
Lyndra's Expandable Pipeline
Advancing toward filing an application with the FDA to begin clinical trials in patients with a once-weekly dose of risperidone, a medication used to treat schizophrenia
Schizophrenia is associated with significant health, social and economic concerns. Individuals with schizophrenia often have difficulty staying on their medications, resulting in relapse rates in as many as 75 percent of patients diagnosed with the disease. Schizophrenia has been associated with high rates of co-occurring medical conditions and an increased risk of premature mortality. Improving access to treatment to reduce the potential for relapse is critical.
In partnership with Allergan, developing an oral once-weekly capsule to deliver sustained release therapies for Alzheimer’s disease.
Nearly six million Americans are living with Alzheimer’s disease and more than 16 million Americans provide unpaid care for people with Alzheimer’s or other dementias. An ultra-long-acting treatment can help extend the time a patient can perform simple daily tasks without full supervision, alleviating stress, reducing costs and potentially delaying the decision to enter patients into nursing homes.
Developing and commercializing ultra-long acting oral HIV therapies in partnership with Gilead Sciences that will allow patients to take pills once a week, or even less frequently.
The treatment of HIV, a virus that affects nearly 40 million people worldwide, was revolutionized by the creation of a single, once-daily combination pill. Yet non-adherence to antiretroviral therapy occurs at a rate of about 30 percent, leading to treatment failure and viral resistance. Gilead has led the way in HIV treatment by focusing on reducing pill burden and also developed the first medication that can reduce the risk of sexually-acquired HIV. Increasing adoption of Gilead’s pre-exposure prophylaxis (PrEP) is helping to stabilize and even reduce HIV diagnosis rates globally.
Working on a once-weekly anti-rejection medication that may help significantly decrease clinical risk of graft rejection, especially among highly non-adherent patient populations such as adolescents and young adults.
Kidney transplant rejection is common, with failure rates as high as 51 percent after 10 years . With more than 95,000 Americans waiting on kidney transplants and more than 19,000 transplants performed each year, minimizing rejection is critical. Yet up to a third of patients report regularly missing doses of daily anti-rejection medications.
OPIOID USE DISORDER
Developing a once-weekly oral dosage of buprenorphine, an FDA-approved medication assisted treatment (MAT), that improves outcomes and saves lives in patients with opioid use disorder.
More than 47,000 Americans died of opioid overdose in 2017 and 2 million more Americans live with addiction to opioids. The National Institute on Drug Abuse (NIDA) has called for new treatment strategies that help address the current opioid crisis, including new formulations of existing medications to improve treatment access and adherence.
MALARIA VECTOR CONTROL
Developing a once-biweekly dosage of ivermectin, a drug that targets malaria-transmitting mosquitoes, to potentially boost the efficacy of mass drug administration and help eliminate malaria.
Nearly half of the world’s population is at risk of malaria and in 2017 an estimated 435,000 deaths due to malaria occurred globally. Efforts at eliminating malaria are limited by the logistic challenges of reaching large rural populations and ensuring patient adherence to adequate pharmacologic treatment.
With a grant from the Bill & Melinda Gates Foundation, developing a once-monthly oral contraceptive to improve access to reliable and affordable birth control to make a potentially significant impact on global women’s health.
Nearly 214 million women of reproductive age in developing regions who want to avoid pregnancy are not using modern contraceptives. Of the estimated 206 million pregnancies in developing regions in 2017, 43 percent were unintended, and care related to those pregnancies totals $8.3 billion annually.