FDA approval paves the way for two Swiss startups

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12.06.2020
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GTX Medical is developing therapies to accelerate recovery and quality of life of people with spinal cord injury while Polyneuron is focusing on the treatment of autoimmune diseases. The two startups received the US Food and Drug Administration (FDA) Breakthrough Device Designation and the Orphan Drug Designation, respectively – an important regulatory milestone that paves the way for future development.

GTX medical developed Go-2 system to promote the recovery of leg motor functions and neurological control in adults with spinal cord injuries (SCI) and paralysis. Specifically, the device is designed to improve the reconnection of the brain with paralyzed muscles in individuals with traumatic spinal cord injury. The Company anticipates the first clinical trial for the complete Go-2 system in humans to take place in 2021.

GTX is also developing the wearable LIFT System, a transcutaneous approach that delivers Non-invasive Electrical Spinal Stimulation (NESS) therapy to treat SCI. The Up-LIFT pivotal trial planned to start in late 2020 aims to demonstrate improved or restored upper limb and hand strength and function through mild pulses delivered through the skin. The LIFT technology received Breakthrough Device Designation in 2017.

“The FDA Breakthrough Device Designation is an important regulatory milestone and underscores the transformative potential of the Go-2 system and the unmet medical need it addresses,” commented Jan Öhrström, Chairman of the GTX Board of Directors. “With Breakthrough Device Designation for the implantable Go-2 system and for the non-invasive LIFT technology, we are now on an accelerated pathway. Both designations support our aim to expeditiously bring GTX’ innovative therapies for improving functional recovery, enhancing the quality of life and independence of people with spinal cord injury.”

Polyneuron addresses rare autoimmune diseases
Polyneuron Pharmaceuticals is a clinical-stage company pioneering a novel therapeutic approach for the effective and safe treatment of antibody-mediated immune diseases. Its Antibody-Catch technology platform enables the chemical design of injectable glycopolymers that are able to selectively eliminate pathological (auto) antibodies, while leaving the rest of the immune system intact. The company’s drug candidate PN-1007 targets the IgM autoantibodies that cause anti-MAG neuropathy, a disabling chronic disorder of the peripheral nervous system that has no approved treatment. PN-1007 (PPSGG) will be used in the treatment of anti-MAG neuropathy, a disabling, chronic disorder of the peripheral nervous system.

Following the receipt of the orphan drug designation from the European Medicines Agency in July 2017, Polyneuron’s PN-1007 has received the FDA orphan drug designation, which is granted to advance the development of safe and effective therapies for the treatment of rare diseases or conditions affecting fewer than 200,000 individuals in the U.S.

“Receiving orphan designation in the U.S. provides additional validation to the development of PN-1007 as a treatment for anti-MAG neuropathy. PN-1007 directly targets and eliminates the auto-antibodies that cause the disease, which we believe could prevent demyelination and protect the nerves,” said Ruben Herrendorff, Ph.D., CEO and co-founder of Polyneuron.

 (Press release/RAN)

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