Parkinson’s Disease Community Sponsor
ABOUT INNOMEDICA
Our Mission.
Cutting-edge nanotechnology for the targeted treatment of diseases.
Innovation in Service of Patients.
InnoMedica is a Swiss pharmaceutical company specialized in drug development with an innovative nanotransport system that aims to improve patient therapy. InnoMedica’s nanocarriers pursue the goal of prolonging the circulation of the transported pharmaceutical agents in the bloodstream and releasing them at the designated location in the body with precision. InnoMedica thereby wants to address the challenge of an efficient biodistribution of active agents in the human body while improving efficacy and reducing side effects. First applications in oncology, neurology, and virology demonstrate the versatility of this nanotechnology. Translation risks in InnoMedica’s drugs are unusually low because InnoMedica does not develop new active substances, but instead equips clinically established medicines with a biological autopilot. At InnoMedica, experienced entrepreneurs and researchers work together in order to bring these drugs to patients as expediently as possible.
Our Technology. Delivery system with precise focus.
The patent-protected drug-delivery system can be combined with a multitude of medical agents and fine-tuned according to specific requirements. This versatility enables its use in a multitude of applications. All pipeline products are based on InnoMedica’s nanocarriers acting as a drug delivery system. The aim is to improve the distribution of the encapsulated active agents in the patient’s body. The nanocarriers are equipped with a biological autopilot intending to release the active agent at the desired tissue in the body.
SPONSORED PRODUCT
Talineuren. Neuroprotective Therapy for Control of Parkinson’s Disease Enabled by Nanoparticle Delivery of GM1 Across Blood-brain barrier, observed in All Clinical Trial PD Patients, and with Regenerative Effects Observed in a Subset of PD Patients
Partners: InnoMedica Switzerland AG and Normax Biomed Limited
Principal Investigator: Dr. med. Michael Schüpbach, Parkinson’s Disease Specialist, Neurologist, Neurology Institut in Konolfingen – Switzerland
Project Manager: Dr. Camille Peitsch, R&D Director, InnoMedica.
Business Management: Dr. Stéfan Halbherr, CEO, InnoMedica, Dr. Jonas Zeller, CFO, InnoMedica, Peter A. Jensen, CEO & Chairman, Normax Biomed
Clinical Trials: Talineuren (TLN-1) Clinical Trials for Parkinson’s Disease
MEDICAL NEED
Talineuren safely delivers neuroprotective therapy for Parkinson’s Disease (PD) with Regenerative Properties for PD patients in early to late stage of disease. InnoMedica currently has Phase I and Phase IIa safety and efficacy data to present to the Biocomm Community.
TARGET PATHWAY CIRCUITRY
Design of Talineuren. Talineuren (TLN) is composed of a liposomal nanocarrier with a unique composition that crosses the blood brain barrier and the active pharmaceutical ingredient GM1 ganglioside with neuroprotective and neurorestorative properties. GM1 is inserted in the membrane of the liposome.
GM1, the “prototype” ganglioside. GM1 is a member of the ganglio-series of glycosphingolipids which has important physiological properties and impacts neuronal plasticity and repair mechanisms, and the release of neurotrophins in the brain.
TLN-1 – The paradigm shift in neurology. TLN-1 transports important biological building blocks into the brain – promoting nerve cell protection and regeneration. TLN-1 overcomes the blood-brain barrier, and (i) can be administered orally or intravenously, (ii) has hardly any side effects and is suitable for long-term treatments, (iii) corrects a lack of GM1 in the central nervous system and regenerates nerve cells, and (iv) is intended for use in Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and many other nervous diseases.
CLINICAL PLAN
Experimental Stages: Completed in Switzerland under regulatory authority Swissmedic, the national authorization and supervisory authority for drugs and medical products: (1) Pre-clinical (murine). Result: Safe and Effective, (2) Phase I Clinical Data. Result: Safe and Effective. And (3) Phase IIa Clinical Data. Result: Safe and Effective (6 months).
Clinical Plan Proposed: (4) Phase IIb (50 PD Patients) in Switzerland. (5) Phase III (300 PD Patients). Route of dose administration: Intravenous, Once per Week.
Add-on therapy. Talineuren is used, as it was in the NEON study, in addition to standard symptom-relieving treatments already prescribed by physicians, with the goal of halting disease progression.
Study design. The LEAP study will be conducted in parallel at several study centers. In this double-blind study, neither the physicians nor the patients know whether Talineuren or a placebo will be administered. Clinical Supply. Talineuren is produced and ready, on-the-shelf, now, in sufficient quantities, to begin Phase IIb immediately following regulatory approval
FUTURE DEVELOPMENT PLAN
Recruitment. Great interest in the NEON study among patients enabled the recruitment of all study participants for the weekly dose increase over a total of 14 levels within a very short time.
Good tolerability. Talineuren is very well tolerated up to the highest intended dose. No significant side effects have been reported to date.
Patient request for further treatment. First patients have completed dose escalation. At the patients’ request, InnoMedica has applied to Swissmedic and the Ethics Committee for further treatment. This was approved and means that the treatments can be continued.
Study conclusion. After treating nine additional patients at the highest dose for two months, the study was completed in the summer of 2022. In addition to tolerability, data on efficacy is reported, and ready for Phase IIb/ Phase III.
INTELLECTUAL PROPERTY
In November 2022 InnoMedica received the Notice of Allowance in the US for the Talineuren patent protecting the blood-brain barrier crossing properties of the lipid nanoparticles. In January 2023 InnoMedica filed an application patent for Talineuren for the treatment of Parkinson’s disease.