Chronic Low Back Pain Due to Disc Degeneration

MPC-06-ID is a Phase 3 product candidate for the treatment of chronic low back pain caused by disc degeneration (CLBP).  It is being developed for patients who have exhausted conservative treatment options, may have failed epidural steroid injections and have no further treatment option other than invasive and costly surgical interventions.

Disease Indication and Patient Population

Over four million patients in the United States alone suffer from CLBP1,2,3,4 , which is caused by damage to the disc as a result of aging, genetics, and injuries. This compromises the disc’s capacity to act as a fluid-filled cushion between vertebrae and to provide anatomical stability. Damage also causes an inflammatory response with ingrowth of nerves that result in chronic pain. This combination results in CLBP and functional disability.

When disc degeneration has progressed to a point that pain and loss of function can no longer be managed by conservative means e.g. medication and physiotherapy, major invasive surgery such as spinal fusion is the only remaining option.

Existing therapies treat the symptoms of the disease, but are not disease-modifying and thus do not address the underlying disease cause. As a result, we believe that the most significant unmet need is a therapy that can not only improve the patient’s pain and function, but has the ability to reverse, halt or slow disease progression.

By treating the cause of CLBP, we believe MPC-06-ID could fill an unmet treatment gap for a large population of patients.

MPC-06-ID

MPC-06-ID is a tier 1 product candidate which consists of a unit dose of 6 million mesenchymal precursor cells (MPCs). It is injected by syringe directly into a targeted damaged disc in an outpatient procedure.

Mechanism of Action

Extensive preclinical studies have established that MPCs have anti-inflammatory effects and secrete multiple paracrine factors that stimulate new proteoglycan and collagen synthesis by chondrocytes in vitro and by resident cells in the nucleus and annulus in vivo. MPCs have also been shown to produce anti-inflammation factors. Together these effects offer the potential to strengthen the load bearing function of the disc by increasing its water content, improving disc anatomy and stability, while also reducing inflammation and pain.

Clinical Trials

Ongoing Phase Trial 3

A Phase 3 clinical program is currently enrolling CDLBP patients.

The first of two Phase 3 clinical trials will use a primary endpoint that comprises both pain relief and improved function, consisting of a 50% reduction in lower back pain as measured by Visual Analog Score and a 15-point improvement in Oswestry Disability Index, with no additional interventions.

Find out more about this Phase 3 trial.

Phase 2 Trial

MPC-06-ID was evaluated in a randomized, placebo and active controlled Phase 2 trial conducted in 100 patients with more than six months of CLBP due to disc degeneration.

In March 2017, 36-month results were released and showed that a single intra-discal injection of 6 million MPCs resulted in meaningful improvements in both pain and function that were durable for at least three years. Previously, 24-month results were presented at the 24th Annual Scientific Meeting of the Spine Intervention Society in July 2016, and received the 2016 Best Basic Science Abstract award at the New Orleans meeting.

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1Andersson GBJ. Epidemiological features of chronic low-back pain. Lancet 1999; 354: 581-85.

2Freburger et al. The Rising Prevalence of Chronic Low Back Pain. Arch Intern Med 2009; 169 (3): 251-258

3Malanga G et al. Epidemiology In: Cole & Herring eds. The Low Back Pain Handbook: A Guide for the Practicing Clinician. 2nd ed. Philadelphia, Pa.: Hanley and Belfus, 2003: 1-7

4DePalma MJ et al. What is the source of chronic low back pain and does age play a role? Pain Med 2011; 12:224-233