预约演示
Gilead-backed Lyndra Therapeutics cuts nearly a quarter of staff as ph. 3 data near
临床3期高管变更临床1期申请上市临床结果
Lyndra is advancing a pipeline of long-acting pills spanning several therapeutic areas.
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.
Lyndra Therapeutics the company's recent decisions to outsource commercial manufacturing and partner on both the development and commercialization of "all future products," a spokespersschizophreniay. 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 collarisperidone not been disclosed or named, the spokesperson said.
Lyndra's core business is a drug delivery platLYN-005un 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.
Lyndra-acting injectable version of the approved drug, Uzedy, wMITat the center of a marketing scandal ten years ago after J&J pled guilty to a criLYN-005isdemeanor charge of improperlyschizophreniae product Risperdaladults for unapproved usesJohnson & Johnsontors 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 calJ&J 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. developmental disabilities
The drug seemingly performed better at reKaruna Therapeuticsymptoms, such as hallucinations, versus “schizophreniaptoms, like fKarXTg withdrawn from the world.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 tschizophreniaof the year.
As for Lyndra, the company in July replaced CEO Patricia Hurter with chief ophallucinationser Jessica Ballinger. The company also announced that chief medical oKaruna Richard Scranton, M.D., would gain the additional title of president of global product development. BallFDAer said at the time that Lyndra had a “clear line of sight to NDA filing” for LYN-005.
Lyndra is also working on long-acting alternatives for opioid use disorder treatments in partnership with the National Institutes of Health.malariaivermectinLYN-064
The company’s last round of fundraising came in June 20opioid use disorderearly $61 million. The fundraising rNational Institutes of HealthSciences, Polaris and AIG Investments, among others.
Editor's note: This story was updated to clarify that Uzedy was a long-acting, injectable version of Risperdal. Both were developed Gilead SciencesPolarisAIG Investments
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