The Mesoblast Ltd (ASX: MSB) share price is sliding today.
Shares in the S&P/ASX 300 Index (ASX: XKO) biotech company closed on Friday trading for $1.15. In morning trade on Monday, they are changing hands for $1.135 apiece, down 1.3%.
For some context, the ASX 300 is down 0.7% at this same time.
Don't feel too bad for shareholders, though.
As you can see on the chart below, the Mesoblast share price has rocketed this year and remains up a whopping 308% over the past six months.
Here's what's happening today.
Image source: Getty Images
Clinical trial launch fails to boost Mesoblast share price
Following on the very strong run higher over recent months, today's pressure on the Mesoblast share price looks to be primarily related to the broader selling on the ASX and US markets rather than the company's announcement of a clinical trial launch.
On that trial front, Mesoblast said patient enrolment at multiple sites across the United States has commenced for the confirmatory Phase 3 trial of its allogeneic, immunoselected, and industrially manufactured stromal cell product rexlemestrocel-L. That's intended for patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease of less than five years.
The United States Food and Drug Administration (FDA) has already confirmed the design of the 300-patient randomised, placebo-controlled trial and the 12-month primary endpoint of pain reduction as an approvable indication.
Key secondary measures include improvement in quality of life and function, as well as reduced opioid usage.
Commenting on the launch of the trial, whose results could offer ongoing support for the Mesoblast share price, Alan Miller, trial investigator at Coastal Health Specialty Care, said, "This therapy has the potential to be groundbreaking and life-changing for the low back pain population."
Mesoblast chief medical officer Eric Rose added:
We are very excited to be actively enrolling our pivotal trial of rexlemestrocel-L across multiple sites and look forward to confirming the durable pain reduction previously observed in the first Phase 3 trial.
There is a significant need for a safe, effective, and durable treatment in patients with CLBP and degenerative disc disease, in particular one that reduces or eliminates opioid use.
In a previous boost for the Mesoblast share price, the FDA designated rexlemestrocel-L, a Regenerative Medicine Advanced Therapy (RMAT) for the treatment of chronic low back pain.
Mesoblast notes that RMAT designation provides all the benefits of Breakthrough and Fast Track designations, including rolling review and eligibility for priority review on the filing of a Biologics License Application (BLA).
Stay tuned.
