risperidone extended release (LYN-005) / Lyndra - LARVOL DELTA

Long-acting oral weekly risperidone (LYN-005) for schizophrenia in the USA (STARLYNG-1): a multicentre, open-label, non-randomised phase 3 trial. (PubMed, Lancet Psychiatry) - P3 | "Weekly LYN-005 provided sustained release of risperidone at therapeutic concentrations with similar bioavailability to immediate-release risperidone. Patients remained clinically stable and no unexpected safety signals emerged. This offers a novel long-acting oral drug delivery technology for schizophrenia and schizoaffective disorder."

Journal • P3 data • CNS Disorders • Psychiatry • Schizophrenia

Starlyng-2: A Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Lyndra Inc. | N=410 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • CNS Disorders • Psychiatry • Schizophrenia

Starlyng-2: A Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder (clinicaltrials.gov) - P3 | N=410 | Not yet recruiting | Sponsor: Lyndra Inc.

New P3 trial • CNS Disorders • Psychiatry • Schizophrenia

Lyndra Therapeutics Announces Strategic Clinical Research and Commercial Manufacturing Services Collaboration with Thermo Fisher Scientific for Long-Acting Oral Therapies (Businesswire) - "Leveraging its Accelerator Drug Development, 360° CDMO and CMO solutions, Thermo Fisher will provide clinical research services for Lyndra’s phase 3 pivotal safety study for oral weekly risperidone (LYN-005), set to begin in 1H 2025, and commercial manufacturing of long-acting oral therapies utilizing Lyndra’s LYNX drug delivery platform."

Commercial • New P3 trial • CNS Disorders

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Risperidone Extended Release Capsules in Patients with Schizophrenia, Schizoaffective Disorder or Bipolar 1 Disorder (ANZCTR) - P1 | N=8 | Withdrawn | Sponsor: Lyndra Australia Pty Ltd | Not yet recruiting ➔ Withdrawn

Trial withdrawal • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia

Bio-Comparability of Long-Acting Oral Weekly Risperidone LYN-005 to Daily Risperidone (STARLYNG-1 study) (SIRS 2024) - "Background: LYN-005 is a long acting, once weekly formulation of risperidone that aims to reduce the pill burden and improve treatment adherence in individuals with schizophrenia and schizoaffective disorders. Approximately 83 subjects were enrolled in the study with 47 subjects completing the study. Dropout rate in Risperdal (n=16 over 1 week) and LYN-005 (n=18 over 5 weeks) periods were similar. Following LYN-005 administration, sustained release of risperidone was noted across all 5 doses."

CNS Disorders • Schizophrenia • LYN

Study to Evaluate the Pharmacokinetics (PK) and Safety/Tolerability of Long-Acting Oral LYN-005 (clinicaltrials.gov) - P3 | N=83 | Completed | Sponsor: Lyndra Inc. | Recruiting ➔ Completed | Trial completion date: Mar 2024 ➔ Dec 2023 | Trial primary completion date: Mar 2024 ➔ Nov 2023

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Psychiatry • Schizophrenia

Lyndra Therapeutics Presents Data on Long-Acting Oral Weekly Risperidone (LYN-005) at American Society of Clinical Psychopharmacology 2023 Annual Conference (Businesswire) - "Lyndra Therapeutics...announced it will present a poster on the results of a simulation-based predictive modeling study comparing the Positive and Negative Syndrome Scale (PANSS) scores produced by oral weekly risperidone (LYN-005) and oral daily risperidone at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, being held from May 30 to June 2, 2023, in Miami, Florida...The models showed that, compared to daily risperidone, oral-weekly risperidone is expected to provide similar exposure to the medication, but with higher trough and lower peak (i.e., more consistent) medication concentrations in the blood. These more consistent medication levels are predicted to reduce fluctuation in total PANSS scores. Additionally....A higher simulated minimum steady-state blood plasma concentration of risperidone with oral weekly risperidone was associated with a slight decrease in PANSS score (meaning a slight reduction in how much symptoms impacted a person’s life)."

Clinical data • CNS Disorders • Schizophrenia

Predicted Panss Score After Weekly LYN-005, a Long-Acting Oral Formulation of Risperidone, Administration (ASCP 2023) - "The simulations predicted that LYN-005 will have similar efficacy to IR risperidone as noted by the decrease in PANSS score at steady state. A slight decrease in PANSS score was noted with an increase in Css,min suggesting that efficacy may be driven by Css,min and not Css,avg. Learning Objectives 1."

CNS Disorders • Psychiatry • Schizophrenia

Lyndra Therapeutics Doses First Clinical Trial Participant in Pivotal Study of Oral Weekly Risperidone (LYN-005) for Schizophrenia and Schizoaffective Disorder (Businesswire) - "Lyndra Therapeutics...announced it has dosed the first participant in its pivotal clinical trial investigating oral weekly risperidone (LYN-005). Lyndra is developing LYN-005 to provide a new treatment option for patients living with schizophrenia, schizoaffective disorder and bipolar I disorder....The oral weekly risperidone pivotal trial is a pharmacokinetic (PK) comparability study evaluating weekly doses of risperidone from LYN-005 that are equivalent to 2 and 6 milligrams of daily risperidone. This trial bridges to previously established safety and efficacy of immediate release (daily) risperidone."

Trial status • Bipolar Disorder • CNS Disorders • Schizophrenia

Study to Evaluate the Pharmacokinetics (PK) and Safety/Tolerability of Long-Acting Oral LYN-005 (clinicaltrials.gov) - P3 | N=90 | Recruiting | Sponsor: Lyndra Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Psychiatry • Schizophrenia

Study to Evaluate the Pharmacokinetics (PK) and Safety/Tolerability of Long-Acting Oral LYN-005 (clinicaltrials.gov) - P3 | N=90 | Not yet recruiting | Sponsor: Lyndra Inc.

New P3 trial • CNS Disorders • Psychiatry • Schizophrenia

A Multiple Dose Study to Assess the Safety, Tolerability and PK of Risperidone Extended Release Capsules in Subjects With Schizophrenia, Schizoaffective Disorder (clinicaltrials.gov) - P2 | N=32 | Completed | Sponsor: Lyndra Inc. | Recruiting ➔ Completed

Trial completion • CNS Disorders • Psychiatry • Schizophrenia

Lyndra Therapeutics (BIO 2022) - "In its first six years, Lyndra has achieved rapid progress, formulating 19 therapies in the lab and advancing four therapeutic products to the clinic, validating the feasibility of its platform with multiple APIs. Thanks to more than $240 million raised to date from investors and partners, Lyndra has advanced the LYNX™ drug delivery platform, prepared oral weekly risperidone (LYN-005) for pivotal trials and opened a custom-built GMP manufacturing facility in Lexington, MA."

Lyndra Therapeutics Announces Positive Outcome of End-of-Phase 2 Meeting with the FDA for Lyndra’s Weekly Risperidone (LYN-005) for the Treatment of Adults with Schizophrenia and Other Indications (Businesswire) - "Lyndra Therapeutics...today announced the positive outcome of an end-of-phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) providing a clear path to approval for Lyndra’s Weekly Risperidone (LYN-005)...The company plans to initiate its pivotal program for LYN-005, designed as the first-ever oral, ultra-long-acting, extended-release therapy, in early 2022. Lyndra and the FDA aligned on key elements of Lyndra’s pivotal program: a ~90-person pharmacokinetic (PK) comparability study that bridges to the previously established safety and efficacy of risperidone and a double-blind safety study of 6 months’ duration to characterize the safety profile of the Lyndra dosage form. Both studies will evaluate LYN-005 at weekly doses ranging from 2 to 6 mg risperidone daily."

FDA event • New trial • Bipolar Disorder • CNS Disorders • Schizophrenia

Lyndra Therapeutics Completes $60.5 Million Series C Financing (Businesswire) - "Lyndra Therapeutics...today announced the closing of its $60.5 million Series C financing. The proceeds of the round...will advance Lyndra’s lead product candidate into pivotal trials as the Company prepares for commercialization in the U.S. In parallel, the Company is expanding its central nervous system (CNS) pipeline assets and actively evaluating high value partnerships across a broad range of disease states."

Financing • CNS Disorders • Schizophrenia

Extended-release risperidone capsule may improve drug adherence in schizophrenia (Healio) - "'Preventing relapse is critical in reducing health care costs and preserving function in individuals with schizophrenia,' David Walling, PhD...told Healio Psychiatry. 'In the U.S. alone, medication nonadherence causes at least 10% of hospitalizations and approximately 125,000 avoidable deaths per year, costing the health care system more than most other diseases. LYN-005 is Lyndra's oral, ultra-long-acting, extended-release risperidone capsule, in development for the weekly treatment of schizophrenia, and it is designed to provide consistent drug levels for an entire week or as long as 1 month from one, normal-sized capsule, which is something no oral therapy has ever achieved.'"

Media quote • Schizophrenia

Once-Weekly Oral Antipsychotic for Schizophrenia on the Horizon (Medscape) - "The new formulation, LYN-005 (Lyndra Therapeutics), quickly reached therapeutic levels in patients, provided sustained exposure to risperidone active moiety over 7 days, and reduced peak drug exposure. 'This novel formulation has the potential to improve treatment adherence and quality of life in patients with schizophrenia or schizoaffective disorder,' study investigator David Walling, PhD...told Medscape Medical News."

Media quote • Schizophrenia

Lyndra Therapeutics Presents Promising Phase 2 Data on Once-Weekly Oral Risperidone Treatment, LYN-005, in Development for Schizophrenia (Businesswire) - P2, N=32; NCT04567524; Sponsor: Lyndra Inc.; "Lyndra Therapeutics...announced results from its Phase 2 study of LYN-005, the Company’s oral, ultra-long-acting, extended-release (ER) risperidone capsule, in development for the weekly treatment of schizophrenia. These data, from the Company’s first repeat dose Phase 2 study in patients, demonstrate that LYN-005 provided sustained therapeutic levels of risperidone over the one-week dosing intervals and reduced peak drug exposure relative to immediate release (IR) risperidone....Results from the clinical trial will be presented in an oral presentation at the 2021 Congress of the Schizophrenia International Research Society (SIRS)...'plans to conduct our end of Phase 2 meeting with the FDA this summer and initiate a pivotal study of LYN-005 in schizophrenia in the second half of this year,'..."

FDA event • Media quote • New trial • P2 data • CNS Disorders • Schizophrenia

[VIRTUAL] Pharmacokinetics, Safety, and Tolerability of Ultra-Long Acting Sustained-Release Oral Risperidone in Patients with Schizophrenia or Schizoaffective Disorder (ASCP 2021) - "Following LYN-005 administration, systemic exposure to risperidone active moiety (risperidone and 9-hydroxyrisperidone combined) increased with increasing dose. Exposure was observed throughout the dosing intervals with peak concentration generally observed within the first 3 days of dosing. Peak exposures from LYN-005 were lower than with IR risperidone."

Clinical • PK/PD data • CNS Disorders • Pain • Psychiatry • Schizophrenia • LYN

[VIRTUAL] Pharmacokinetics, Safety, and Tolerability of Ultra-Long Acting Sustained-Release Oral Risperidone in Patients with Schizophrenia or Schizoaffective Disorder (SIRS 2021) - P1, P1b | "Both high and low doses of LYN-005 were well tolerated. Once weekly delivery of risperidone with this novel formulation has the potential to improve treatment adherence and quality of life of patients with schizophrenia or schizoaffective disorder."

Clinical • PK/PD data • CNS Disorders • Schizophrenia • LYN

[VIRTUAL] Pharmacokinetics, Safety, and Tolerability of Ultra-Long Acting Sustained-Release Oral Risperidone in Patients with Schizophrenia or Schizoaffective Disorder (SIRS 2021) - P1, P1b | "Both high and low doses of LYN-005 were well tolerated. Once weekly delivery of risperidone with this novel formulation has the potential to improve treatment adherence and quality of life of patients with schizophrenia or schizoaffective disorder."

Clinical • PK/PD data • CNS Disorders • Schizophrenia • LYN

[VIRTUAL] Pharmacokinetics, Safety, and Tolerability of Ultra-Long Acting Sustained-Release Oral Risperidone in Patients with Schizophrenia or Schizoaffective Disorder (SIRS 2021) - "Both high and low doses of LYN-005 were well tolerated. Once weekly delivery of risperidone with this novel formulation has the potential to improve treatment adherence and quality of life of patients with schizophrenia or schizoaffective disorder."

Clinical • PK/PD data • CNS Disorders • Schizophrenia • LYN

Lyndra Therapeutics achieves critical milestones despite COVID-19 headwinds (Businesswire) - "Lyndra Therapeutics...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%....Based on this progress and additional studies showing safety in humans, Lyndra is on track to begin Phase II trials this summer."

Enrollment closed • New P2 trial • CNS Disorders • Schizophrenia

Lyndra Therapeutics files IND, bolsters leadership team and readies for manufacturing (Businesswire) - "Lyndra Therapeutics...has filed an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) for its ultra-long-acting oral therapy to treat schizophrenia (risperidone)....'We now have multiple clinical trials underway and plan to initiate a Phase II trial mid-year.'...Lyndra also announced that it has selected a site in Lexington, Mass. for its first manufacturing site, which will supply clinical materials for later development and enable manufacturing scale-up. The new GMP-compliant site is scheduled to begin operations in the first half of 2020..."

Commercial • IND • New P2 trial