WATERTOWN, Mass.--(BUSINESS WIRE)--Lyndra Therapeutics, a clinical-stage biotech company working to make daily pills a thing of the past, achieved significant milestones in the first half of 2020 despite COVID-19 headwinds, naming Örn Almarsson as Chief Technology Officer, completing enrollment and dosing of its Phase I clinical trial for an ultra-long-acting oral risperidone therapy to treat schizophrenia, ramping up manufacturing capabilities and growing its employee base by 28%.
“The past few months show the resilience of our team, and we’ve not only stayed on course but actually built momentum toward our goal to reinvent medicines,” said Lyndra CEO Dr. Patricia Hurter. “Our first U.S. Phase I clinical trial has completed dosing, a new GMP manufacturing site has been commissioned and is now operational and manufacturing clinical materials for our first Phase 2 study, scale-up is on schedule and we’re attracting and recruiting the best in biotech, including leaders such as Örn Almarsson who have successful track records with accelerated development and commercialization.”
As CTO, Örn Almarsson will oversee discovery and product development as Lyndra progresses multiple new therapies leveraging its platform. Almarsson, who most recently led the delivery science team at Moderna Therapeutics, which developed their COVID-19 vaccine delivery system, has extensive experience in pharmaceutical R&D, product design and evaluation, with a focus on translation of new drug delivery concepts into clinical trials. Prior to Moderna, he was Vice President, Pharmaceutical R&D at Alkermes.
“While at Alkermes, I saw how we could address addiction by changing the way patients take medicine, and that ultimately drew me to Lyndra and its novel work at the intersection of materials and medicines,” said Almarsson. “I look forward to translating what we learn in the clinic and applying the learnings to therapies that address addiction, diabetes and many other diseases.”
First U.S. Phase I Study Completes Enrollment
Lyndra recently completed patient enrollment in its Phase I trial for an ultra-long-acting oral risperidone therapy for schizophrenia. This study marks the first time that Lyndra’s dosage form has been administered to patients with the underlying condition. Based on this progress and additional studies showing safety in humans, Lyndra is on track to begin Phase II trials this summer.
“We’re pleased to have successfully translated our preclinical work and platform studies with healthy volunteers into successful enrollment in this Phase I trial in patients with schizophrenia,” said Dr. Richard Scranton, Chief Medical Officer, Lyndra, who is responsible for the company’s clinical trial programs. “Thanks to our highly transparent, close working relationship with regulatory agencies and experienced team, we’ve launched a robust trial program that will serve as a blueprint for rapidly bringing new therapies from our platform into the clinic.”
Manufacturing Scale-up; Employee Growth
As Lyndra expands its clinical trial programming, it has also started scaling up new manufacturing operations in Lexington, Mass. In April, the facility started manufacturing materials for the company’s Phase II clinical trials, scheduled to start later this year. Lyndra continues to expand its manufacturing capabilities to support current and planned clinical trials and future commercialization needs.
To support manufacturing scale-up and accelerated growth across operations, advancement of its platform and the progression of new programs into clinical development, Lyndra is aggressively hiring. Since the start of 2020, the company expanded its employee base by 28%, despite the challenges associated with social distancing during the pandemic.
About the Phase I Study
The open-label, single-dose non-randomized study is to evaluate safety, tolerability and pharmacokinetics of risperidone extended release capsules in patients with schizophrenia or schizoaffective disorder. The intervention, in a total of eight patients, is LYN-005, a single extended release (ER) capsule containing risperidone (14 mg). The rationale for the development of this ER capsule is to reduce the frequency of dosing orally administered risperidone medications to once weekly or less and thereby improve the management of the disease.
About Lyndra Therapeutics’ Platform
Lyndra Therapeutics’ orally administered dosage form is designed to deliver sustained, steady-state release of one or more drugs for up to a week or longer while temporarily residing in the stomach. Taking a single, long-acting capsule weekly instead of daily or more often can improve medication adherence and health outcomes while reducing burdens on individuals and their caregivers. Inside a familiar capsule is a star-shaped formulation with active pharmaceutical ingredients that are released consistently over time. The formulation, which is designed to open once inside the stomach, eventually exits safely via the gastrointestinal tract, along with undigested food.
About Lyndra Therapeutics
Lyndra Therapeutics is reinventing medicines to make daily pills a thing of the past, replacing them with its oral, ultra-long-acting, sustained-release therapies. Administering and conveniently distributing medicines in weekly or longer-term doses – including using polypill approaches – will improve safety, efficacy and adherence to maximize global health impact and lower overall healthcare costs. For more information, visit the company’s website www.lyndra.com.