Stayble Therapeutics vision är att ge en varaktig smärtlindring och ökad funktion hos patienter med kronisk diskrelaterad ryggsmärta. BioStock kontaktade dr Douglas Beall, Key Opinion Leader och medlem i Staybles vetenskapliga råd, för att få veta mer om behovet av nya behandlingsalternativ för dessa patienter, särskilt i USA.

Stayble Therapeutics är ett svenskt life science-bolag som utvecklar en injektionsbehandling för kronisk ländryggssmärta på grund av diskdegeneration (degenerativ disksjukdom). Bolagets läkemedelskandidat STA363 injiceras in i disken vilket skapar en omvandling av bindväven. Detta eliminerar läckage avinflammatoriska molekyler och stabiliserar disken, vilket kan ge permanent smärtlindring för patienten. För närvarande pågår en fas IIb-studie med STA363 för att visa den avsedda smärtreducerande effekten.

Staybles huvudmarknader är USA, Japan och EU5, där cirka 100 miljoner patienter lider av kroniskdiskrelaterad ryggsmärta orsakad av degenerativ disksjukdom.

Intervju med dr Douglas Beall

Bolagets vetenskapliga råd spelar en viktig roll i utvecklingen av STA363. En av medlemmarna i rådet är dr Douglas Beall, MD, Chief of Interventional Spine Services och Chief of Radiology Services vid Clinical Radiology of Oklahoma i USA.

Dr Beall, som rekryterades till Staybles vetenskapliga råd för ungefär ett år sedan, har lång erfarenhet av smärtbehandling och ryggrelaterade problem. Han har också varit involverad i flera kliniska prövningar av nya behandling för diskdegeneration, vilket är mycket värdefullt i utvecklingen av STA363, särskilt med tanke på framtida kliniska fas III-prövningar i USA.

BioStock kontaktade Dr Beall för att få veta mer om hans tidigare erfarenhet inom området och hans tankar kring Stayble Therapeutics behandling 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.

Prenumerera på BioStocks nyhetsbrev