Lyndra Therapeutics is undergoing significant changes, including the appointment of Jessica Ballinger as its new CEO, following the replacement of the longtime CEO, Patricia Hurter, Ph.D. This transition comes as the company prepares for the upcoming interim data release for a pivotal trial of their long-acting, orally administered schizophrenia medication. Additionally, Lyndra has plans to initiate a pivotal safety study in 2024. As part of these changes, the company is also reducing its workforce by approximately 23%.
These cost-saving measures align with Lyndra’s recent decisions to outsource commercial manufacturing and establish partnerships for the development and commercialization of future products. Additionally, the company is relocating from its Watertown, Massachusetts headquarters to a nearby facility in Lexington.
Lyndra intends to collaborate on its lead asset, LYN-005, although the identity of the partner remains undisclosed. LYN-005 is an oral weekly risperidone, originally developed by Johnson & Johnson. Risperidone is one of the most prescribed treatments for patients with schizophrenia. A phase 3 trial for this innovative pill began in March, with plans to enroll 90 patients.
Lyndra aims to enhance the drug’s duration and rebuild its reputation, considering the history of a long-acting injectable version of the same drug, Uzedy, which was at the center of a marketing scandal involving J&J a decade ago.
Meanwhile, Karuna Therapeutics is preparing for the potential approval of its novel schizophrenia drug, KarXT. Recent phase 3 results indicated an 8.4% reduction in the Positive and Negative Syndrome Scale, a schizophrenia symptom measure. Karuna anticipates submitting its application to the FDA in the coming days, following its estimate of a third-quarter submission.
Lyndra is also actively working on a long-acting version of another antipsychotic, Abilify, though it remains in the preclinical stage. Additionally, the company has two phase 1-stage candidates for diabetes medication Farxiga and Crestor.
Lyndra’s innovative drug delivery platform has garnered attention from the Bill and Melinda Gates Foundation, which is supporting trials of a long-acting version of the malaria pill ivermectin and a once-a-month, oral contraceptive named LYN-064.
Furthermore, Lyndra is collaborating with the National Institutes of Health on long-acting alternatives for treating opioid use disorder.
The company’s most recent funding round took place in June 2021, securing nearly $61 million with support from Gilead Sciences, Polaris, AIG Investments, and other stakeholders.