Immupharma (IMM)

Sector:

Pharma and Biotech

Index:

FTSE AIM All-Share

2.05p
   
  • Change Today:
      0.19p
  • 52 Week High: 5.90p
  • 52 Week Low: 1.09p
  • Currency: UK Pounds
  • Shares Issued: 499.72m
  • Volume: 3,515,017
  • Market Cap: £10.24m
  • RiskGrade: 328

ImmuPharma clears 'important' regulatory hurdle for Lupuzor trial

By Josh White

Date: Monday 27 Jul 2020

LONDON (ShareCast) - (Sharecast News) - Specialist drug discovery and development company ImmuPharma announced what it called "an important regulatory milestone" on Monday, in preparation for the new optimised international phase 3 trial of 'Lupuzor' for the autoimmune disease systemic lupus erythematosus.
The AIM-traded firm said its licensing partner, Avion Pharmaceuticals, has submitted a special protocol assessment request to the US Food and Drug Administration (FDA).

It said the special protocol assessment process would see sponsors reach an agreement with the FDA on the design and size of clinical trials, so that they adequately address scientific and regulatory requirements for a study that could support marketing approval.

The previous phase 2 clinical trial of Lupuzor in systemic lupus erythematosus was also carried out under ImmuPharma's special protocol assessment.

ImmuPharma said the review period for such an assessment request was up to 45 days.

"On 28 November 2019, ImmuPharma and Avion signed an exclusive licence and development agreement and trademark agreement for Lupuzor, with Avion agreeing to fund a new international phase 3 trial and commercialising Lupuzor in the US," the board explained in its statement.

"Since then, both companies have been working closely on the clinical trial design and strategy, bolstered by consultation with an eminent group of key opinion leaders.

"This tripartite phase 3 protocol development approach provided thorough and detailed support for developing the most relevant clinical trial for Lupuzor in systemic lupus erythematosus patients."

The company said data and results from the first phase 3 clinical study were analysed and considered in detail and, as a result, a new optimised international phase 3 study protocol had been finalised, and was now the subject of the special protocol assessment request to the FDA.

"The new Phase III study design will be communicated to the market at a later date, once agreed with the FDA."

At 1459 BST, shares in ImmuPharma were up 1.5% at 15.25p.

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Note 1: Prices and trades are provided by Digital Look Corporate Solutions and are delayed by at least 15 minutes.

Note 2: RiskGrade figures are provided by RiskMetrics.

 

Immupharma Market Data

Currency UK Pounds
Share Price 2.05p
Change Today 0.19p
% Change 9.92 %
52 Week High 5.90p
52 Week Low 1.09p
Volume 3,515,017
Shares Issued 499.72m
Market Cap £10.24m
RiskGrade 328

Immupharma Star Ratings

Compare performance with the sector and the market.
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Key: vs Market vs Sector
Value
28.96% below the market average28.96% below the market average28.96% below the market average28.96% below the market average28.96% below the market average
17.39% above the sector average17.39% above the sector average17.39% above the sector average17.39% above the sector average17.39% above the sector average
Price Trend
38.61% below the market average38.61% below the market average38.61% below the market average38.61% below the market average38.61% below the market average
8.7% below the sector average8.7% below the sector average8.7% below the sector average8.7% below the sector average8.7% below the sector average
Income Not Available
Growth Not Available

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Immupharma Key Personnel

CEO Timothy Paul McCarthy

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