Stayble Therapeutics’ vision is to provide a lasting pain relief and increased function in patients with chronic disc-related back pain. To learn more about the need for new treatment alternatives for these patients, particularly in the US, BioStock got in touch with Dr. Douglas Beall who is Key Opinion Leader and member of Stayble’s Scientific Advisory Board.
Stayble Therapeutics is a Swedish life science company developing an injection treatment for chronic low back pain triggered by disc degeneration (degenerative disc disease). The company’s candidate STA363 is injected into the spinal disc to induce a connective tissue transformation, potentially providing permanent pain reduction by eliminating leakage of inflammatory substances and stabilizing the disc. A phase IIb trial with STA363 is currently underway to demonstrate the intended pain reducing effect.
Stayble’s primary markets are the US, Japan and the EU5, covering around 100 million patients suffering from chronic disc-related back pain caused by degenerative disc disease.
Interview with Dr. Douglas Beall
The company’s Scientific Advisory Board (SAB) plays an essential role in the development of STA363. One of the members of the board is Dr. Douglas Beall, MD, Chief of Interventional Spine Services and Chief of Radiology Services at Clinical Radiology of Oklahoma, US.
Dr. Beall, who was recruited to Stayble’s SAB about a year ago, has extensive experience in pain management and back-related problems. He has also been involved in several clinical trials on new interventions in disc degeneration, which is very valuable in the development of STA363, especially with regard to future phase III clinical trials in the US.
BioStock contacted Dr Beall to get to know more about his previous experience within the field and his thoughts on Stayble Therapeutics’ treatment STA363.
Dr. Beall, could you tell us a bit more about your professional background and previous experience of clinical trials in degenerative disc disease?
–My background includes training in diagnostic radiology, musculoskeletal radiology and interventional radiology and I am board certified as a Radiologist and Interventional Pain Physician. I have focused on treating spine pathology through inteventional surgical techniques for more than two decades and have been treating intradiscal conditions since the advent of chymopapain.
– My recent work with the intervertebral disc includes clinical trials for regeneratives treatments such as cellular allograft augmentation, rexlemestrocel-L, injectable discogenic cell therapy, and expanded autologous bone marrow concentrate and nocioceptive destructive therapies such as intraosseous denervation of the basivertebral nerve and the use of chondroitinase.
– I have also been engaged in clinical trials evaluating sythetic polymers used to augment the structure and function of the intervertebral disc and have participated in benchtop and clinical research at all levels including laboratory development, phase I trials, first-in-man clincal evaluations, early feasibility studies, pilot trials, phase II & III trials and post market/registry clincial evaluations. As you can tell, I have a tremendous love for developing successful treatments for patients suffering from discogenic back pain.
What specific learnings within this field are you bringing into the development of STA363 as member of Stayble’s Scentific Advisory Board?
– The STA363 treament is an incredibly important niche in the treatment of degenerative disc disease and the often persistent back pain that comes along with internal disc disruption. The treatments of regenerative therapies, nocioceptive denervation and discal augmentation are all viable treatments for intervertebral disc related pain but none has the specific clinical application of STA363 that accelerates the natural changes in connective tissue that transitions the disc from painful to non-painful.
– The clinical selection of these patients has been difficult for some investigational sites but not for others. This primarily has to do with the diagnostic capabilities of identifying these patients and the clarity of understanding of which patients are good candidates for participating in the clinical trials. Despite the ubiquitous nature of painful degenerative disc, the selection of patients for clinical trials remains slow and cumbersome. Given our extensive research of the painful intervertebral disc we have refined patients selection algorithms and have brought together an outstanding association of clinical investigators to refine the selection process to speed up patients recruitment while optimizing subject selection.
Would you say that there is a need for new treatments for degenerative disc disease, as well as an overall drive for medicinal innovation in the US?
– There is a trend toward focusing on the intervertebral disc as a source of back pain and a focus toward correcting the clinical problem. In the U.S., low back pain is second to the common cold for the number of visits to the doctor and is the single largest cause of disability. This prevalence of this disability has increase dramatically over the past two decades and is not a focus for treatment development. We are at the beginning of the upward swing of the curve for treating discogenic back pain and are seeing a strong surge in interest and products used for this purpose. This is something we have not typically seen in the past and some of the early clinical research successes have only increased the already substantial focus on treatment for degenerative disc disease.
»STA363 is an optimal treatment for patients with painful degenerative disc disease as it essentially speeds up the normal changes in collagen that is seen with typical aging «
What benefits do you see with STA363 compared to current treatment options?
– STA363 is an optimal treatment for patients with painful degenerative disc disease as it essentially speeds up the normal changes in collagen that is seen with typical aging so it can be interpreted by the recipient as a normal physiologic process that is delivered through a needle rather than something performed surgically. The speed of improvement and the optimal early clinical results are benefits that are strongly preferable to either marginally effective or ineffective conservative measures or to invasive surgical options.
BioStock has recently reported on the opioid crisis running rampant in the US, with more than half a million deaths due to opioid overdose. How would STA363 make a difference in this context?
–The opioid crisis in the U.S. has not abated over the past few years and continues to be a significant contributor to patient morbidity and mortality. A significant contributor to this epidemic are patients with painful degenerative disc disease that are treated with opioid medications and become physically dependent on these medications. As the devastation from the chronic use of these medications have become apparent there has been a desire to turn away from pain medications and toward effective interventional therapies for common sources of chronic pain. Right at the top of the list for chronic painful conditions is painful degenerative disc disease and any effective therapy can be seen as a way to reduce the harmful dependence on opioid medication.
»I was also impressed by the outstanding team assembled by Stayble and believe that this organization and its injectable therapeutic is poised for success.«
Finally, what was it with Stayble Therapeutics and its candidate STA363 that attracted your interest?
–I am immediately attracted to promising and minimally invasive treatments for painful degenerative disc disease. The injectable STA363 is a novel and effective treatment for painful degenerative disc disease and is based on a therapeutic strategy that has produced very meaningful improvements in patients’ pain and function. I was also impressed by the outstanding team assembled by Stayble and believe that this organization and its injectable therapeutic is poised for success.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.