logo-loader
ImmuPharma PLC

ImmuPharma targets regulatory approval as follow-up study confirms “outstanding” safety profile of Lupuzor

Snapshot

The drug developer also recently raised £2.66mln from its institutional investor, Lanstead Capital, to help execute its corporate strategy

ImmuPharma PLC - ImmuPharma targets regulatory approval as follow-up study confirms “outstanding” safety profile of Lupuzor

Quick facts: ImmuPharma PLC

Price: £0.10

Market: AIM
Market Cap: £15.98 m
Follow
  • Flagship drug is Lupuzor – a treatment for lupus

  • Results from follow-up study confirmed “outstanding” safety profile

  • Nucant cancer treatment also going through the clinic

 

What it does

ImmuPharma PLC (LON:IMM) specialises in developing drugs for serious medical conditions for which there is a distinct lack of existing treatments.

Its flagship drug is called Lupuzor – a treatment for the autoimmune disease lupus.

The drug missed its primary endpoint in a phase III 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 study in July confirmed Lupuzor’s “outstanding and robust safety profile”, with no serious adverse events reported.

On top of that, ImmuPharma was also able to show that a third of the patients taking the drug were in remission at the end of the study.

Another 500 lupus sufferers are being given access to Lupuzor for the next two years as part of a managed access programme (MAP).

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.

The company was also given a boost in June after it raised around £2.66mln from a subscription agreement with institutional investor, Lanstead Capital, which it said would be used primarily to fund the execution of its corporate strategy including progressing Lupuzor through both corporate partnerships and regulatory pathways and proactively pursuing the 'spin-off' of the subsidiary companies, Ureka and ELRO, in order to unlock their future potential and enhance value to shareholders.

What the chairman says – Tim McCarthy

Blue Sky

Following the success of the follow-up study, ImmuPharma is now hoping that Lupuzor can prove itself again in the MAP.

If the programme succeeds, the company will look to use the data to get full regulatory approval for the drug, something bosses have previously said they 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.

With the shares trading around 9.4p as of 12 August 2019, Immupharma carries a market cap of £16.08mln.

Watch

Immupharma chairman details £2.66mln financing and open label extension study

ImmuPharma PLC’s (LON:IMM) chairman Tim McCarthy caught up with Proactive London's Andrew Scott to discuss the results of a follow-up study which was designed to evaluate Lupuzor’s safety and tolerability. McCarthy says the six month extension study confirmed its outstanding and robust...

on 4/7/19

3 min read

;