Flagship drug is Lupuzor – a treatment for lupus
Results from follow-up study due within next few months
Nucant cancer treatment also going through the clinic
Ureka subsidiary being divested
What it does
Its flagship drug is called Lupuzor – a treatment for the autoimmune disease lupus.
The drug missed its primary endpoint in a phase II study last year, but the outcome was more nuanced than the top line results suggested and actually showed that Lupuzor worked well in certain patients, chiefly those who were antibody-positive.
The results certainly haven’t held back ImmuPharma or its top drug. In fact, boss Tim McCarthy has said that Lupuzor still possesses “blockbuster potential”, meaning it could rack more than US$1bn in annual sales.
After the end of the phase III trial, 62 patients took part in a ‘follow-up’ study – called an open-label extension study. Results from this are expected between April and June.
On top of that, another 500 lupus sufferers are being given access to Lupuzor for the next two years as part of a managed access programme.
In addition to helping patients, the AIM-quoted drug developer expects to collect more valuable data on Lupuzor, which will be useful if and when it decides to press ahead with regulatory filings.
In the immediate future, results from the Lupuzor follow-up study are due by the end of June, while the managed access programme is set to complete towards the end of 2020.
Should Lupuzor prove itself in those two tests, ImmuPharma will use the data to try to get full regulatory approval the drug, something bosses hope to achieve “in the medium term”.
Lupuzor isn’t ImmuPharma’s only drug going through the clinic. Its Nucant cancer treatment has yielded “promising results” in two phase I safety and dose-finding studies.
The company has signed heads of terms on a clinical development collaboration with oncology specialist Incanthera, in which ImmuPharma has taken a £2mln stake.
A licence agreement between the two is expected to be signed by the end of March, a deal which is likely to see Incanthera pay an upfront licence fee of £1mln in shares and cover all the development costs for the Nucant programme.
All future commercialisation revenues will be shared equally, ImmuPharma has said.
What the boss is saying