Gilead-backed Lyndra Therapeutics cuts nearly a quarter of staff as ph. 3 data near

Lyndra Therapeutics is laying off roughly 23% of its staff, two months after the company swapped out longtime CEO Patricia Hurter, Ph.D., and as a pivotal trial for a long-acting, oral schizophrenia drug nears an interim readout.

The cuts come after the company's recent decisions to outsource commercial manufacturing and partner on both the development and commercialization of "all future products," a spokesperson said Friday. The company is also leaving its headquarters in Watertown, Massachusetts, and is consolidating at a nearby location in Lexington.

"With our topline data readout from our pivotal trial of oral weekly risperidone expected in the next few weeks, we feel these changes will set us up to successfully navigate the regulatory pathway ahead and ultimately bring oral weekly medications to patients," the spokesperson said.

The company plans to partner up on lead asset LYN-005, though a collaborator has not been disclosed or named, the spokesperson said.

Lyndra's core business is a drug delivery platform spun out of MIT that aims to significantly reduce the dosing frequency required for oral pills. LYN-005 is a longer-acting version of schizophrenia medicine Risperdal, originally developed by Johnson & Johnson. A phase 3 trial for the pill started in March and is looking to enroll 90 patients.

Risperdal was at the center of a marketing scandal ten years ago after J&J pled guilty to a criminal misdemeanor charge of improperly marketing the product to older adults for unapproved uses. Federal prosecutors also alleged that the company falsely marketed the product to younger children and people with developmental disabilities. Lyndra hopes to boost the drug's duration and reclaim its reputation in the process. 

The biotech’s clinical progress comes as Karuna Therapeutics gears up for approval of its own, novel schizophrenia drug called KarXT. Recent phase 3 results showed that patients on the treatment experienced an 8.4% reduction on the Positive and Negative Syndrome Scale, a measure of schizophrenia symptoms.

The drug seemingly performed better at reducing “positive” symptoms, such as hallucinations, versus “negative” symptoms, like feeling withdrawn from the world. Karuna’s application is expected any day after the company estimated it would formally submit a package to the FDA in the third quarter of the year. 

As for Lyndra, the company in July replaced CEO Patricia Hurter with chief operations officer Jessica Ballinger. The company also announced that chief medical officer Richard Scranton, M.D., would gain the additional title of president of global product development. Ballinger said at the time that Lyndra had a “clear line of sight to NDA filing” for LYN-005. 

Lyndra is also working on a long-acting version of another antipsychotic, Abilify, though that candidate remains in the preclinical stage. Elsewhere, the company has two phase 1-stage candidates for diabetes med Farxiga and Crestor.

The company's platform has drawn interest from the Bill and Melinda Gates Foundation, which is helping fund trials of a long-acting version of malaria pill ivermectin in addition to a long-acting, once-a-month, oral contraceptive, LYN-064.

Lyndra is also working on long-acting alternatives for opioid use disorder treatments in partnership with the National Institutes of Health. 

The company’s last round of fundraising came in June 2021 when it bagged nearly $61 million. The fundraising round was supported by Gilead Sciences, Polaris and AIG Investments, among others. 

Editor's note: This story was updated to correct that Risperdal was at the center of a lawsuit from by the US Department of Justice, not Uzedy as previously reported. The latter is a long-acting, injectable version of the generic drug risperidone that's developed by Teva and MedinCell.