Mesoblast’s (MESO) Regenerative Cell Therapy Proves Itself in Back Pain Trial – Economic Calendar

This morning, Australian biotech company Mesoblast Ltd (NASDAQ:MESO) announced encouraging phase 2 trial data regarding its regenerative therapy for chronic lower back pain (CLBP). Mesoblasts proprietary allogeneic Mesenchymal Precursor Cells (MPCs) are given to patients via a single injection and, in the clinical trial, have proved to spark significant improvement in both lower back pain and function that lasted for at least 36 months.

The sustained benefits on pain and function over three years seen with a single injection of Mesoblasts cell therapy have the potential to transform the treatment paradigm for chronic low back pain due to disc degeneration, said Dr. Hyun Bae, the trial investigator and Director of the Spine Institute.

According to Bae, there is growing evidence that disc degeneration can be healed instead of needing to be replaced or fused. Researchers are quickly arriving at this inflection point in the treatment of lower back pain, which is especially critical given the ongoing opioid abuse epidemic sweeping the nation.

Researchers believe that MPCs are turned on by signals in damaged tissues that spark factors to block damaging inflammation and begin repairing the afflicted area.

The phase 2 trial in question involved 100 patients, who were treated with either six million or 18 million MPCs via one intra-discal injection or a placebo of either saline or hyaluronic aid. The primary endpoints were a 50 percent drop in Visual Analog Scale (CAS), which is a pain metric, and a 15-point reduction in Oswestry disability index (ODI) at both the one and two year marks.

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The primary endpoint composite at the two-year mark was met by 41 percent of patients in the 6 million MPC arm, 35 percent in the 18 million arm, with just 18 percent and 13 percent in the placebo groups. The phase 2 results support the companys criteria for its ongoing phase 3 program.

Mesoblast is confident that the durable treatment outcomes in lower back pain are part of an overarching mechanism that might also have a positive effect in other types of chronic conditions where a single injection of MPCs can lead to sustained benefits. Two of these potential indications, according to Mesoblast, are chronic heart failure and biological-resistant rheumatoid arthritis.

Following the trial data being released, Maxim Groups Jason Kolbert reaffirmed a Buy rating on Mesoblasts stock and maintained a price target at $14.00. The upside indicated is 81 percent.

The market opportunity is significant and the treatment fits ideally within the existing paradigm the analyst told investors this morning. Injecting cells versus steroids with a better AE profile and now a better long-term result.

Earlier this month, Mesoblast announced that its MSC-100-IV therapy had been given Fast Track designation by the Food and Drug Administration (FDA) for its use in children with steroid refractory acute Graft Versus Host Disease (aGVHD). This type of designation shortens the FDA review path from ten months to six months, and certain portions of the Biologics License Application (BLA) can be sent in on a rolling basis rather than when everything is finished.

The author of this article holds no position in any of the stocks mentioned above.

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Mesoblast's (MESO) Regenerative Cell Therapy Proves Itself in Back Pain Trial - Economic Calendar