May 8, 2018

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LYNDRA THERAPEUTICS

What if we stop trying to change the patient and instead we changed the pill?

December 6, 2019

A once-a-month oral contraceptive

 To improve patient adherence, we developed an oral contraceptive that is administered once a month.    
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Overview

Lyndra Therapeutics is making daily pills a thing of the past. Instead of trying to change the patient to improve adherence, Lyndra is changing the pill. 

Medication non-adherence is a $289 billion problem in the U.S. alone. Instead of having to take medications daily or more frequently, Lyndra’s oral, ultra-long-acting, sustained-release therapies, could allow patients to take medication weekly, or even monthly This would improve medication adherence and health outcomes and help lower the cost of care.

Lyndra’s near-term focus is on addressing health conditions where therapeutic need is largely unmet and where patient non-adherence has been well documented to adversely affect health outcomes. The current pipeline includes therapies for Alzheimer’s disease, HIV, opioid use disorder and schizophrenia as well as a new once-monthly option for oral contraception.

Why Oral Sustained-release is better

In studies of patients with chronic illness, once-weekly dosing has been associated with better adherence levels and greater odds of remaining adherent than once-daily dosing: the medication adherence hazard ratio is nearly two-times higher* (see figure 1).

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 (see figure 2).

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 (see figure 3).

*Iglay, K., e al., Clinical Therapeutics, 2015

Changing the pill, not the patient

Lyndra’s dosage form is a normal capsule containing a drug containing element with components specifically designed to perform certain functions during oral administration, gastric residence and lower GI passage. There is a central “core”, drug-containing “arms” radiating from the core delivering controlled drug release and disintegrating matrices that join the arms to the core. The star-shaped drug containing element folds to fit inside a normal everday capsule for oral administration.

Once inside the stomach, the capsule dissolves, the dosage form unfolds and the drug containing element  remains in the stomach and begins to deliver the medicine to the patient. After seven days of remaining in the stomach, the specially designed disintegrating matrices are designed to break down, allowing safe passage through the lower GI tract.

The Lyndra Extended Release Oral Capsule is the first ultra-long-acting capsule that lasts a week or longer and can provide a wide range of medicines in a familiar oral capsule form. Once inside the stomach, the capsule delivers steady amounts of medicine for seven days or more. The dosage form has a modular design which provides a unique opportunity to deliver either a single drug or multiple drugs at the same time from just one capsule. The images above and video below provide an overview of the dosage form.