Lyndra’s Extended Release Capsule Delivers Drug Consistently
Lyndra released clinical data in July 2020 at the 2020 Alzheimer’s Association International Conference demonstrating that two separate drugs can be delivered safely with predictable pharmacokinetics via its once-weekly dosage form. This was the first clinical study showing that it is possible to convert a once-daily combination therapy into a weekly dosage. It demonstrated controlled, steady release of medication over an extended period, something no oral therapy had previously achieved. The pharmacokinetics data also showed that an ultra-long-acting oral dosage form has the potential to reduce drug side effects and improve efficacy.
Daily dosing side effects are often associated with peaks and lack of efficacy with troughs.
Oral, ultra-long-action, sustained-release therapies can also deliver better pharmacology, efficacy and safety. Preclinical studies of therapeutic effect over seven days have shown higher bioavailability; a lower concentration maximum or peak (Cmax), which can reduce side-effects; and no “burst release,” which can reduce efficacy and compromise safety
Lastly, once-weekly dosing offers increased pharmacologic forgiveness. Because the Lyndra formulation is shown to provide a longer dosage half-life, the therapeutic range is maintained even when a next dose is delayed for multiple days
- Advantages in systemic, non-systemic, and local target delivery due to continuous & steady delivery
- Possibility of reducing total dose while maintaining efficacy (non-inferiority)
- Reducing Cmax has the potential to, or could improve side effects
- Forgiveness if delayed administration
- Reduced healthcare costs through better pharmacology and measurable health outcomes
- Patient freedom from the burden of daily medications
- Adaptable for wide range of single agents and combinations
- Discreet user controlled administration
- Reduced pill burden
- Reduced caregiver burden
- Superior Pharmacology for existing Agents
- Loss of Exclusivity (LOE)
- Combination Products
- Local GI Delivery
- Non-systemic Delivery Enhanced Continuous Release
* Darren M. Roberts, Jacob Sevastos, Jane E. Carland, Sophie L. Stocker and Tom N. Lea-Henry CJASN August 2018, 13 (8) 1254-1263;
Lyndra has continued to expand its pipeline and is currently in Phase 2 with it’s schizophrenia program. Greater than 120 patients and healthy volunteers have participated in Lyndra’s clinical trials to date over 7 completed clinical studies.