August 29, 2018

Our Science

Lyndra is reinventing medicine for a healthier world by pioneering ultra-long-acting oral therapies, which has never been done before.

Our Pipeline of Ultra-Long-Acting Oral Therapies

Our oral dosage form delivers medicine better in order to deliver better medicine

Our revolutionary drug delivery technology is more than just extended release. It is a novel ultra-long-acting oral formulation that achieves steady, consistent drug release for the entire dosing period, reducing the peaks and troughs of daily dosing. Phase 2 data of our lead asset oral weekly risperidone (LYN-005) showed that LYN-005 quickly reached therapeutic levels in patients, provided sustained risperidone drug levels for repeat one-week dosing intervals and reduced peak drug exposure relative to daily risperidone. 1

Source: Data on file as presented at the 2021 Congress of the Schizophrenia International Research Society (SIRS)

This graph shows the pharmacokinetic (PK) data from the LYN-005 Phase 2 study. The thin vertical lines represent PK measurements. The high and low ends of the lines show the range of measurements across all patients, the thick blue horizontal line shows the average and the pink shaded bars represent the desired target PK concentration range between Cmax and Cmin. For the study, all patients were placed on oral daily risperidone for 14 days. The far left of the graph—between -1 and 0 on the y axis—shows frequent sampling of PK from patients on the last day of oral daily risperidone. You can see a fast rise to the peak concentration level (Cmax) at the beginning of the day and a fall to the Cmin at the end. At day 0, patients stopped taking oral daily risperidone and took the first Lyndra dose, followed by 2 more doses each a week apart. For each of the Lyndra doses, you can see the blood concentrations quickly enter and remain in the therapeutic window throughout the dosing period, with a lower peak concentration than the daily tablets, which is a desirable feature.

An innovative Platform with a wide range of potential applications

Lyndra’s ultra-long-acting oral drug delivery technology has the potential to transform virtually any medicine into weekly or even monthly therapies. Built on groundbreaking work out of the Langer Lab at MIT, it contains more than 20 patented innovations in design, engineering and material science to achieve dramatically improved dosing frequency.

Patients and caregivers find the concept of shifting from daily to oral weekly dosing appealing. According to our research, nearly 90% of patients and caregivers say they prefer oral pills over any other drug delivery method including injectables. Additionally, although they’d never heard of the concept before, 80% find an oral weekly pill appealing. 1

We believe there are boundless opportunities to apply Lyndra’s platform to deliver better medicines.

Our commitment to Central Nervous System Conditions

We’ve taken a thoughtful approach to demonstrate the value of our ultra-long-acting oral technology. That is why we’ve prioritized oral weekly risperidone for the treatment of people living with schizophrenia or bipolar 1 disorder.

We know that staying adherent to prescribed medicines can be challenging for individuals living with these conditions and their caregivers, and that nonadherence increases the risk of relapse and hospitalization, also severely impacting quality of life.

A recent study conducted on behalf of Lyndra showed a pressing need and strong desire for an oral weekly option amongst individuals living with schizophrenia and bipolar disorder and their caregivers.1 Recent research also found a significant interest among psychiatrists to prescribe an oral weekly option. 2 

Following a successful June 2021 End of Phase 2 meeting with the FDA, we are preparing to initiate pivotal trials in early 2022 for oral weekly risperidone (LYN-005) for patients with schizophrenia. Read more about our pivotal trial plans in our press release.

Click Here For More Information on our PRE-APPROVAL ACCESS POLICY.

Looking Beyond CNS

In addition to our research in CNS, we are prioritizing the development of therapies for which reduced dosing frequency would provide the most significant clinical benefits to patients and caregivers. This includes a focus on global and public health, including:

  • Opioid use disorder (Lyndra’s oral weekly levomethadone (LYN-014) for the treatment of opioid use disorder was granted Fast Track designation by the FDA in July 2021)
  • Malaria eradication 
  • Pregnancy prevention

Our global and public health programs are supported by the Bill and Melinda Gates Foundation and the National Institute of Health’s National Institute on Drug Abuse (NIDA). There are opportunities for partnership on these and other programs, including programs for which we have Phase 1 clinical data (i.e., Alzheimer’s disease, type 2 diabetes, dyslipidemia). Please contact us to connect about partnership opportunities.

Click Here For More Information on our FINANCIAL CONFLICT OF INTEREST POLICY AND PROCEDURES

References