ImmuPharma PLC (LON:IMM) said the database lock of its phase III clinical trial of Lupuzor, for the autoimmune disease lupus, is expected on April 6.
This is a significant milestone. It denotes the end of the pivotal study, but also prevents unauthorised or unintended changes to the information garnered.
This particularly important when the drug assessment is double-blind, which simply means the physicians don’t know whether patients are receiving the drug or a placebo with no medical benefits.
For more a fuller explanation of database lock, click here
Top-line results from the trial are expected by mid-April, ImmuPharma said after being updated by Simbec-Orion, the contract research firm carrying out the work.
Chairman Tim McCarthy said: "With the continued robust safety record of Lupuzor achieved over this trial, we look forward with confidence to reporting top line results in the near future."
A total of 200 lupus patients took part in the study, which it is hoped will provide a breakthrough for sufferers.
Systemic Lupus Erythematosus (SLE) is a debilitating and painful disease, which sees the body's immune system turn against itself for reasons still not fully understood.
It can affect various organs in various people in various ways so many symptoms can ensue, which calls for treatment from heart, liver and skin specialists.
Strong cash position
According to the Lupus Foundation of America, around 1.5mln in the States have the condition, with 90% of those estimated to be women.
In a note to clients, analysts at ‘house’ broker Northland Capital said a £10mln raise completed in January, ImmuPharma is in a strong cash position.
“Should Lupuzor successfully meet the trial endpoints, the company will be in a strong negotiating position with potential partners,” it added.
Northland repeated its ‘buy’ rating and 181p target price on the stock.
In late afternoon trading, Immupharma shares were 2.4% lower at 124.5p.
-- Adds broker comment, share price --