product pipeline

Ropinirole Implant

for the treatment of Parkinson's Disease

Preclinical in progress
Preclinical not started
Preclinical not started
Preclinical not started
Preclinical not started
Preclinical Phase 1 Phase 2 Phase 3 Market

The Ropinirole implant is a subdermal implant utilizing Titan's proprietary ProNeura drug delivery platform. It has the potential to deliver continuous, non-fluctuating levels of this dopamine agonist in order to provide continuous dopaminergic stimulation (CDS) for a minimum of three months - and potentially six months or longer - from a single treatment.

Overview of Parkinson's Disease

Bridging the Gap in Treatment with the Ropinirole Implant

Continuous dopaminergic stimulation (CDS) by subdermal delivery of dopamine agonists through the Ropinirole implant may palliate motor complications and delay or prevent the onset of dyskinesia (the involuntary movements often associated with Parkinson's disease).

What is Parkinson's Disease

Parkinson’s disease is characterized by the loss of dopaminergic neurons, which alters activity in the brain region impacting movement and motor function.

Current Treatments

Parkinson’s disease is treated with drugs designed to replace or mimic dopamine in the brain.

Following several years of chronic treatment, these drugs can lose their benefit and trigger serious side effects.

Research

Pulsatile dopaminergic stimulation from current oral treatment may cause motor side effects.

Market Need

1 MIL

People that are affected by Parkinson's disease in the U.S.

This number is expected to almost double by 2030 because of the aging population.

60K

People are newly diagnosed with Parkinson's disease each year

23K

Deaths related to Parkinson's disease, annually

The Cost of Treating Parkinson's Disease

US Sales of Dopamine Agonists*
Year Total Sales $ DA
2012 $1.1 bil $286 mil
2022 $2.3 bil $414 mil
Cost to American Society **
$14.4 billion annually
Treatment Cost $8.1 billion Indirect Cost $6.3 billion
If costs continues to rise, they could double by 2040

*Source: GlobalData

**Source: Parkinson’s Action Network, National Center for Health Statistics; “The Current and Projected Economic Burden of Parkinson’s Disease in the United States” Movement Disorders, March 2013

ProNeura Parkinson's Disease Program

Non-Clinical Proof-of-Concept

The Ropinirole implant, a dopamine agonist approved for the treatment of Parkinson’s disease and restless leg syndrome, was evaluated in a Parkinsonian primate model using the ProNeura™ technology.

Demonstrated Results:

  • Sustained plasma Ropinirole levels for several months following the ProNeura implantation
  • No local skin irritation at the site of the implant
  • Controlled Parkinson's disease symptoms without triggering dyskinesia

Next Steps

In consultation with the scientific advisors:

  • Develop a non-clinical study plan to support Investigational New Drug (IND) application
  • Design a proof-of-concept clinical study
  • Submit a pre-IND meeting package to the Food and Drug Administration (FDA) in Q4, 2015
  • Complete non-clinical studies to enable timely submission of IND and commence ‘proof of concept’ clinical study in late 2016

The ProNeura Long-term, Continuous Drug Delivery Platform

ProNeura is designed to provide continuous drug release with non-fluctuating medication levels over a period of three months to a year. It is ideal for treating chronic diseases for which the maintenance of stable medication levels could offer advantages over other routes of administration.

Learn More About ProNeura