Mesoblast Limited (MESO) announced Sunday that it received positive feedback from the FDA regarding its potential Biologics License Application for rexlemestrocel-L, an allogeneic cell therapy designed to treat chronic discogenic low back pain. The news suggests the company is getting closer to submitting a formal application for approval.

The update comes after an FDA Type B meeting where regulators reviewed data from Mesoblast's first randomized controlled Phase 3 trial, known as MSB-DR003. That study tracked pain reduction and the relationship to decreased opioid use or complete elimination for up to three years following a single administration of rexlemestrocel-L. The company is seeking approval based on reduction in chronic low back pain through 12 months.

What the FDA Said About Pain Relief

When comparing outcomes between rexlemestrocel-L and placebo from the MSB-DR003 trial, the FDA acknowledged that effects on pain intensity appear to favor the active treatment arm. That's regulatory speak for "this seems to work."

The FDA also confirmed that a clinically meaningful reduction in pain intensity in the active arm versus placebo at 12 months can support product efficacy. Perhaps more importantly for patients struggling with addiction, regulators stated that the robust results on opioid reduction from at least one adequate and well-controlled trial could be included in the Clinical Studies section of product labeling.

Meanwhile, a second randomized controlled Phase 3 trial called MSB-DR004 is currently recruiting participants and is over 50% enrolled. The company expects to complete enrollment of the 300-patient target within the next three months. Rexlemestrocel-L has already received Regenerative Medicine Advanced Therapy designation from the FDA for chronic low back pain, which can expedite development and review.

The Opioid Crisis Connection

Mesoblast CEO Silviu Itescu highlighted the broader implications: "Rexlemestrocel-L could offer a powerful solution for management of chronic inflammatory back pain with the added potential to contribute to the administration's goals of opioid reduction or cessation."

The company is particularly focused on treating patients already on opioids, since discogenic back pain accounts for approximately 50% of prescription opioid usage in the United States. That's a staggering statistic that underscores just how many people are dealing with chronic back issues.

The trial results on opioid reduction are striking. In Mesoblast's first randomized controlled Phase 3 trial of 404 patients—168 of whom were taking opioids at baseline—more than three times as many patients treated with a single intra-discal injection of rexlemestrocel-L plus hyaluronic acid were able to cease use of all opioids by 36 months compared with saline-treated controls. That difference was statistically significant at p=0.008.

Mesoblast is also pursuing accelerated FDA approval for Revascor, which is rexlemestrocel-L used for ischemic heart failure with reduced ejection fraction and inflammation. The company appears to be building a pipeline around its cell therapy platform.

Stock Movement: Mesoblast (MESO) shares were down 3.41% at $16.85 at the time of publication on Tuesday.