Lyndra's CNS Pipeline
Lyndra's CNS Pipeline

Central Nervous System Disorders

People living with CNS disorders, particularly those relating to mental health, have unique challenges adhering to their prescribed medications. Lyndra’s long-acting oral therapies have the potential to increase adherence, thus preventing relapses and improving outcomes, while freeing people from the burden of daily pills and simplifying their lives.

SCHIZOPHRENIA AND BIPOLAR 1 DISORDER

woman with hand on distressed mans shoulder
Meeting the need for greater stability
Despite effective treatments, medication adherence in schizophrenia and bipolar disorder is a significant issue with quantifiable negative impacts on health and costs. Lyndra is creating the first long-acting oral treatment for people living with schizophrenia and bipolar 1 disorder: oral weekly risperidone (LYN-005). Risperidone is one of the most prescribed treatments for patients with schizophrenia.14 Lyndra’s oral weekly risperidone (LYN-005) is planned to begin pivotal clinical trials in late 2022.
~ 81 %
Patients or caregivers like the idea of oral weekly pills
Research conducted on behalf of Lyndra found that nearly ~90% of people living with schizophrenia and bipolar disorder or their caregivers find the idea of oral weekly pills replacing their current daily pills appealing.15
~$ 270 B
Estimated yearly schizophrenia-related costs in the US
The Schizophrenia and Psychosis Action Alliance estimates the annual cost of schizophrenia in the US is ~$280B, including costs associated with caregiver burden and labor, reduced quality of life, shorter life expectancy, unemployment, reduced wages, supportive housing, homelessness and incarceration.16
~ 60 %
Psychiatrists favor oral weekly over oral daily
Psychiatrists surveyed in research conducted on behalf of Lyndra more strongly favor oral weekly over oral daily risperidone based on a description of the target product profile.17
~ 50 %
Patients and caregivers report low medication adherence
Research conducted on behalf of Lyndra found that ~60% of people living with schizophrenia or bipolar disorder and their caregivers self-report low medication adherence, and almost ~100% self-report at least a moderate struggle with adherence.18

Our commitment to central nervous system disorders

Lyndra has taken a thoughtful approach to demonstrating the value of its long-acting oral technology, which is why the company has prioritized oral weekly risperidone for the treatment of people living with schizophrenia or bipolar 1 disorder.

Staying adherent to prescribed medicines can be challenging for individuals living with CNS conditions and their caregivers and nonadherence can increase the risk of relapse and hospitalization, also severely impacting quality of life.

While many effective treatments exist, people living with these conditions often struggle with poor 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.

elderly woman looking out the window

Clinical Trials

Promising Phase 2 data with oral weekly risperidone

The results of the Phase 2 study of oral weekly risperidone (LYN-005) provided proof of concept for the LYNX™ drug delivery platform. The Phase 2 data presented in April 2021 showed a sustained release of risperidone from LYN-005 over seven days in the target dosing range of oral daily (immediate release) risperidone. LYN-005 was safe and well-tolerated. Most adverse events were mild and transient, decreasing with repeat dosing.

1 Days
In clinical trials, oral weekly risperidone achieved sustained release of risperidone for seven days.

Pivotal pharmacokinetic study

Based on the outcome of a successful End of Phase 2 meeting with the FDA in June 2021, Lyndra is planning to initiate pivotal clinical trials for oral weekly risperidone (LYN-005) in late 2022. One pivotal study will be a pharmacokinetic (PK) comparability study, comparing LYN-005 to daily (immediate release) risperidone. This study aims to build upon the previously established safety/efficacy of daily risperidone.

~ 80 People
Participating in the oral weekly risperidone PK comparability study.

Pivotal safety study

As part of its pivotal program for oral weekly risperidone (LYN-005), Lyndra is planning to initiate a pivotal safety study in 2023. This double-blind study will test the safety of oral weekly risperidone compared to daily (immediate release) pills.

~ 290 People
Participating in the oral weekly risperidone pivotal safety study.

14. IQVIA Analytics Link Net Sales, November 2021

15. Patient Unmet Needs Survey (Q3’21; n=1645 patients and caregivers)

16. Schizophrenia and Psychosis Action Alliance, “Societal Costs of Schizophrenia and Related Disorders Infographic,” https://sczaction.org/wp-content/uploads/2021/07/Final-Infographic.pdf

17. Risperidone Prescriber Survey (Q3’21; n=77 Psychs)

18. Patient Unmet Needs Survey (Q3’21; n=1645 patients and caregivers)