There was massive buying into small cap drugs stock ImmuPharma Corp (LSE:IMM) following yesterday’s update on its Lupuzor/P140 pharmacokinetic study, which is needed by the US Food & Drug Administration as part of projected phase 3 trials for lupus patients. Volumes in the stock were truly impressive, driving the shares up from 5p to at one stage being quoted at 9.5p, although that was brief.
We have not seen interest in ImmuPharma shares like this since the buying frenzy at the back end of November 2019, before the pandemic re-wrote the rules for biotech stock valuations. The company said that the data from the pharmokinetic study demonstrated that it had met the key endpoints required by the FDA.
This positive PK data now clears the path for commencement of all clinical studies within the company’s P140/Lupuzor platform. In addition to lupus, there is a planned Phase 2a/3 pivotal trial in chronic inflammatory demyelinating polyneuropathy.
“The PK results are highly significant for the progress of the P140 program,” explained Dr Tim Franklin, the company’s COO. “The ImmuPharma Biotech team in Bordeaux also performed predictive modelling in animals that not only confirmed our confidence to detect P140 in the human PK study, but also proved, in those models, that P140 continues to work long after it disappears from the plasma.”
How big a problem is lupus?
Lupus is a disease that can damage many parts of the body, including the joints, skin, kidneys, heart, lungs, blood vessels and brain. It is an autoimmune disease—an illness that occurs when the body mistakenly detects its own tissue as foreign and attacks itself, and it can be fatal in some severe cases.
The number of people living with systemic lupus in the United States is estimated to be approximately 200,000. According to the American College of Rheumatology, 10 times more women than men have lupus, and the disease often starts between the ages of 15 and 44.
According to the FDA, there is still an enormous need for better therapeutics. Scientists may be on the cusp of developing more refined therapies to help control symptoms and foster remission.
Development of lupus treatments picking up speedThe FDA has already approved a couple of treatments. The first targeted therapy for lupus – Benlysta – was approved in 2011, initially fur adults but later for children as young as five years old. In December 2020 it approved Benlysta as the first targeted therapy for the treatment of adult patients with lupus kidney involvement, one of the more severe forms of the disease.
In July 2021 the FDA approved Saphnelo, also to target systemic lupus. “Despite these advances, however, there remain many people with lupus who need additional treatment options,” the FDA said in August 2021. “The FDA remains committed to working with researchers, drug developers, and patients to help make new treatments a reality.”
“After having only one therapy approved for lupus during the past 60 years, it is a cause for celebration to have two new treatment options approved in 2021 alone for this life-threatening autoimmune disease that affects an estimated 1.5 million Americans,” observed Stevan W. Gibson, president and CEO, Lupus Foundation of America. He was speaking following the news of the Saphelno approval in August.