Just found this on Facebook - interesting reading.
ST
A significant impact on back pain
Mesoblast 15 March 2021
Australian-based biotechnology company developing adult stem-cell therapies based on its proprietary MPC and MSC platforms. Its lead programs are in pediatric aGvHD, heart failure, ARDS and lower back pain, all of which are in Phase III or later.
Next events FDA guidance on clinical programs
Mesoblast is a research client of Edison Investment Research Limited Mesoblast announced results from the MPC-06-ID trial in 391 patients with chronic low back pain due to degenerative disc disease. Patients were randomized to receive a single intra-discal injection of either rexlemestrocel-L alone or rexlemestrocel-L in combination with hyaluronic acid (HA), a vehicle thought to improve mesenchymal stromal cell (MSC) homing to inflammation sites, and saline.
While rexlemestrocel-L showed a significant impact on pain, the primary endpoint was a composite responder analysis (at the 24-month time point) involving pain (via VAS) and the Oswestry Disability Index (ODI). This endpoint was not met and a new trial, with a pain-focused endpoint, might be necessary (although opioids, the current mainstay of treatment, have not shown a functional benefit either and additionally, rexlemestrocel-L appears to be opioid sparing (40% reduction)).
US$110m private placement completed In March, the company announced a US$110m private placement led by the principals of SurgCenter Development, one of the largest private operators of ambulatory surgical centers in the United States specializing specifically in spine, orthopedic and joint procedures.
This investment provides some validation for the back pain data from medical specialists familiar with treating back pain.Heart failure trial hits 3P-MACE
The company also recently announced the results of Revascor in 537 patients with chronic heart failure. The trial demonstrated a benefit on the three-point major adverse cardiovascular events (3P-MACE) endpoint, which focuses on reduction in cardiac death, heart attack or stroke with a p-value of 0.027. However, the primary endpoint, which focused more on symptom worsening than actual cardiac events, was not met and we believe an additional trial will be necessary for approval.
Valuation: A$4.1bn or A$6.35 per share We have decreased our valuation from A$4.9bn or A$8.41 per share (A$7.88 per diluted share) to A$4.1bn or A$6.35 per share (A$5.86 per diluted share).
This report has been commissioned by Mesoblast and prepared and issued by Edison
Expand
(20min delay)