BlueRock Therapeutics secures FDA fast track for Parkinson’s disease cell therapy

BlueRock, a Bayer subsidiary, is currently assessing the pluripotent stem cell-derived dopaminergic neuron therapy in a phase 1 study.

This early-stage trial is set to enroll ten patients across the US and Canada, with its primary aim to evaluate the safety and tolerability of DA01 cell transplantation at one year post-transplant.

As a secondary aim, BlueRock will evaluate the evidence of transplanted cell survival and motor effects at one- and two years post-transplant and assess the continued safety and tolerability at two years, as well as the feasibility of transplantation.

Joachim Fruebis, chief development officer of BlueRock, said that receiving fast track designation from the FDA is a crucial step, which will help them further progress clinical development of their DA01 cell therapy approach for Parkinson’s disease. 

In 2019, Bayer bought out its private equity partner Versant Ventures and its founders in BlueRock Therapeutics for USD 240 million, three years after setting up the company.

The decision gave Bayer complete control of BlueRock’s cell therapy pipeline, headed by DA01 and spanning various diseases in the neurology, cardiology, and immunology categories.

Omniscient Neurotechnology rakes in USD 29 Million to map out the electrical networks 

Omniscient Neurotechnology, an Australian startup is developing artificial intelligence software to assess the networks of electrical connections unique to every person’s brain.

With the recent close of its series B funding round, which brought in about USD 29.3 million, the company hopes to cross the vital line between developing high-potential, but still largely theoretical, technology and weaving those methods into actual clinical use.

To do so, Omniscient will utilize the financing to expand market access for its existing brain-mapping platforms, in part by increasing its global sales team. It will also hasten its R&D pipeline and add to the science and engineering teams behind those efforts to advance neurological research and progress new hardware.

So far, Omniscient has built two platforms to map out and assess the brain’s electrical networks. Both use machine learning to draw this information from MRI scans.

Infinitome proffers up analysis for use in research settings, with a platform for studies that aim to comprehend better how diseases such as Alzheimer’s, epilepsy, schizophrenia, multiple sclerosis, and others impact the brain’s electrical connections and potentially help distinguish valuable significant biomarkers.

Quicktome, meanwhile, was designed for clinical use. The platform offers neurosurgeons a clearer picture of the inner workings of their patients’ brains ahead of major operations, mapping out the areas responsible for speech, movement, and thought. Eventually, with the help of brain-mapping AI, Omniscient aims to offer surgeons a way to perform more precise and safer procedures preserving essential functions.

Neuspera Medical scores USD 65 Million for the nerve-stimulating implant to treat overactive bladder

Neuspera Medical’s miniaturized neuromodulation device is making an outsized influence on the field of medical technology.

The device is implanted into the body to instigate nerves linked to chronic illnesses, inhibiting the signals that may result in painful symptoms. The neuromodulation therapy is managed by an external wireless controller, which can transmit electromagnetic pulses through skin, fat, muscle, and bones to trigger the indicated nerves when worn close to the body.

The system has now received a significant vote of confidence in the form of a USD 65 million Series C funding round. That is more than double Neuspera’s early 2019 series B, which brought in USD 26 million across two tranches and nearly triples the company’s lifetime funding. The round was co-led by Vertex Ventures HC and Treo Ventures, each of which will send representatives to Neuspera’s board of directors.

The bulk of the financing will be funneled toward the California-based startup’s ongoing clinical trial exploring the ability of the neuromodulation system for urinary urgency incontinence treatment; its first indicated use.

To address symptoms of overactive bladder, the receiver device is implanted into the lower back, adjacent to the sacral nerve. Once in place, the external controller wirelessly emits electromagnetic waves to the receiver, which sends signals to the nerves and the brain to help normalize bladder function.

Rivus’ fat-trimming therapy nabs USD 35 Million to harness biology against a host of diseases

Rivus Pharmaceuticals is going after the diseases:- Type 2 diabetes; severe hypertriglyceridemia (SHTG); non-alcoholic steatohepatitis (NASH); and heart failure with preserved ejection fraction (HFpEF). These are just the start for the tiny biotech as it nabs USD 35 million for a big push into the clinic.

The series A for the Charlottesville, Virginia-based startup was co-led by Longitude Capital and Medicxi, with help from RxCapital. It looks to carry on with a new class of oral, once-daily, small molecule drugs called Controlled Metabolic Accelerators (CMAs).

These are designed to enhance cellular metabolism and treat the underlying cause of metabolic and cardiovascular disease, comprising the blockbuster potential fatty liver disease NASH and obesity and hypertension, among others.

Allen Cunningham, President, and CEO of Rivus Pharmaceuticals said that the CMAs are made to effectively aim at the root cause of these diseases by enhancing cellular metabolism with the potential to halt the progress of, or even reverse, these diseases. CMAs work as a new approach to stimulate mitochondrial uncoupling, a natural process in the body that regulates and dissipates energy.