The Chicago Bulls were champions of the NBA. “Saving Private Ryan” and “Armageddon” were box office winners. Bill Clinton was president.
That’s how long it’s been since the last significant breakthrough in the treatment of chronic inflammatory diseases such as arthritis, Crohn’s, fibromyalgia and psoriasis that torment millions of people across the world.
SetPoint Medical, one of the nearly three dozen companies in the Santa Clarita Valley’s bioscience and medical devices cluster, is working to flip the script, beginning a U.S. pilot trial in March for patients with drug refractory rheumatoid arthritis (RA).
“This will be life-changing, life-saving, when we get it right,” SetPoint’s President and CEO Anthony Arnold said. “The diseases we can treat will impact your family – if they haven’t already – and we have the ability to treat them maybe better than anybody in the world.”
In a multi-center study that is scheduled to eventually include 15 adult patients, from the ages of 22-75, SetPoint’s proprietary bioelectric device will be surgically placed on the vagus nerve to deliver electrical doses on a preset schedule to test for safety and tolerability. The first two patients were implanted in April.
SetPoint’s received Investigational Device Exemption approval from the U.S. Food & Drug Administration earlier this year to initiate the trial.
“It is incredibly exciting to be the first center in the U.S. to enroll a subject in this trial of SetPoint Medical’s bioelectronic modulation system for the treatment of patients with rheumatoid arthritis who have had inadequate responses to multiple treatments,” said Dr. Norman Gaylis, CEO of AARDS Research, Inc., a Florida-based clinical research organization. “The opportunity to try a completely different therapeutic approach for my RA patients will hopefully lead to another treatment option for this very debilitating disease.”
In its quest to combat RA, an autoimmune disease that, if left untreated, can result in permanent joint damage or deformity, SetPoint has been working to develop novel bioelectronic medicine that will not only send the disease into remission but do so in a way that is safer and more natural than medication.
RA affects 1.5 million people in the U.S. alone, according to the Arthritis Foundation.
First, SetPoint conducted a proof-of-concept study with a modified commercial neuromodulation device. The company published results in Proceedings of the National Academy of Science (PNAS), reporting that 11 of 17 patients saw a clinically meaningful drop in their Disease Activity Score (DAS28) without any serious adverse side effects.
That set the stage for this ongoing trial, which, if deemed successful following an FDA review, would lead to a larger study of some 200 patients, Arnold said.
“The goal of the first study, first and foremost, because this has never been done, is, ‘Is it safe?’ If the answer is yes, the next question is, ‘Did it make patients better?’ he said.
The early reviews of SetPoint’s coin-sized device have been positive.
“The new implantable device designed by SetPoint Medical is an exciting development for RA therapy,” said Dr. Heather Spader, director of pediatric neurosurgery research at Joe DiMaggio Children’s Hospital, also in Florida. “It is extremely easy to place, with no external battery or wires that need to be connected, and it can even be removed if needed. All of these things make it an ideal potential new option for drug refractory rheumatoid arthritis.”
“Despite the effectiveness of biologic and targeted agents for the treatment of rheumatoid arthritis, many patients either do not respond, lose therapeutic response or are intolerant to these agents,” said Dr. Mark C. Genovese of the Stanford University Medical Center. “There remains a real need to develop alternative therapeutic approaches for the treatment of patients with drug refractory disease. Bioelectronic medicine represents a novel and promising approach for patients who need other options for treatment of their rheumatoid arthritis.”
The most recent remarkable advancement in the treatment of RA, in Arnold’s mind, was the 1998 introduction of Enbrel. While other TNF and JAK inhibitors and B-cell depleting agents have since debuted, Arnold said all “carry serious potential side effects that can be worse than the disease,” leaving bioelectronic medicine as the next frontier.
“Nothing as novel and promising has come along in this space in the past couple of decades,” Arnold said.
He added, “What we hope to see is, we implant this, turn it on and the inflammation goes away.”
SetPoint is headquartered on Rye Canyon Loop in the Southern California Innovation Park.
Neotech debuts two new products
SetPoint isn’t the only Santa Clarita-based bioscience and medical device company in the news.
In April, Neotech released its NeoGlo 2.0 and the NeoGlo Sleeve, the latest in a line of innovative neonatal, pediatric and respiratory products that began in 1987 with its Meconium Aspirator.
“Things have changed over the years and people have come and gone, but the one thing that has remained constant is that we’re here for the babies,” said Mitch Hacker, a marketing specialist at Neotech, based on Witherspoon Parkway in the Valencia Commerce Center.
The company’s new products were both developed from clinician feedback following the release of the original NeoGlo in August 2017. The 2.0 model features a new light setting to aid in the examination of soft tissue and is now available in three additional colors.
The NeoGlo Sleeve, meanwhile, was developed to protect the NeoGlo from bodily fluids, potentially helping to control the spread of infection.
“The clinicians’ input is not only what drives our innovation but also our improvement. That’s what we’re known for, that we listen to the clinicians,” said Sara Dimmitt, Neotech’s manager of business development.
She added, “Our motto is, ‘Making a difference,’ and that is truly what we’re doing.”
Founded in Chatsworth, Neotech relocated to the SCV in 2005.