August 29, 2018

Our Therapies

Ultra-Long-Acting Oral Dosing is Achievable

Our Team has developed the first ultra-long-acting pill that lasts a week or longer and can provide a wide range of medicines in a familiar oral capsule form. Once inside the stomach, the capsule delivers steady amounts of medicine for seven days or more.  Our once-weekly product has safely demonstrated gastric residence with predictable pharmacokinetics in humans.  There are no other oral products which provide ultra-long-acting therapeutic coverage or a controlled, steady delivery of medicine which can reduce side effects and improve drug efficacy, resulting in measurable health outcomes.

  • 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 can 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
  • Alzheimer's Disease - Once Weekly

    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. Lyndra partnered with Allergan to develop an oral once-weekly capsule to deliver sustained-release memantine hydrochloride, a drug for Alzheimer’s disease. 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.

  • Psychiatric Disorders - Once Weekly

    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. Lyndra is advancing toward filing an application with the FDA to begin clinical trials on a once-a-week dose of risperidone, a medication used to treat schizophrenia.

  • Transplant Rejection - Once Weekly

    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. Lyndra is 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 who have the highest risk of graft loss.

  • Opioid Use Disorder - Once Weekly

    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. Lyndra is 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.

  • Malaria Vector Control - Once Biweekly

    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. Lyndra is developing a weekly dosage of ivermectin, a drug that targets malaria-transmitting mosquitoes, that can interrupt the vector transmission of malaria for up to 14 days. The drug could boost the efficacy of mass drug administration and help eliminate malaria.

  • HIV - Once Weekly

    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. Lyndra is collaborating with Gilead Sciences to develop and commercialize ultra-long-acting oral HIV therapies that will allow patients to take a pill once a week, or even less frequently. 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.

  • Oral Contraceptive - Once Monthly

    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. With a grant from the Bill & Melinda Gates Foundation, Lyndra is developing a once-monthly oral contraceptive to improve access to reliable, affordable birth control and potentially make a significant impact on global women’s health with a discreet, convenient family planning option.