ImmuPharma says it welcomes 'helpful' FDA recommendations ahead of phase III study
Lupuzor, also known as P140, is being taken through a final-stage study by ImmuPharma’s American partner Avion Pharmaceuticals
Company
LON:IMM
ImmuPharma PLC is a biopharmaceutical company that specializes in the usage and development of biopolymers, specifically peptides. The company is dedicated to developing an innovative portfolio of peptide-based therapeutic drugs with a focus on autoimmunity/inflammation and anti-infectives.
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Lupuzor, also known as P140, is being taken through a final-stage study by ImmuPharma’s American partner Avion Pharmaceuticals
The company said the FDA response was detailed and included significant guidance on next steps for the clinical programme
The drug developer also unveiled a broker option to raise an additional £1.3mln
The agreed date from the FDA for providing its written responses is 29 August 2022
Avion Pharmaceuticals has a licence and development agreement in the States for Lupuzor, also known as P140
It is in discussion with potential non-US licensees for its key asset Lupuzor, with its early-stage anti-infective also attracting attention
The clinical evaluation of Lupuzor will be overseen by the company’s US partner, Avion Pharmaceuticals
Researchers have successfully completed a pharmacokinetic of the company's lead asset
The PK evaluation is part of the new, optimised international phase III trial of Lupuzor in patients with lupus, a condition where the immune system attacks the body’s own tissue and organs
The cash injection will be used to fund research and development
Chief operating officer, Dr Tim Franklin, said: "We are all extremely excited to be working with such a world-leading academic institute."
P140 is proving to be a platform technology rather than a single treatment
Lupuzor is being developed for the treatment of the autoimmune disease Lupus
The update follows a recent streamlining of the company’s board and management
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The evaluation will take eight-to-12 weeks to complete
After 16 years with the company, Dimitri Dimitriou is handing over the reins to chairman Tim McCarthy
Dr Tim Franklin has been with the company for three years
Avion Pharmaceuticals has been granted what’s called a Type C meeting with the Food & Drug Administration
The update followed guidance proffered by the US regulator after its meeting with Avion Pharmaceuticals in December, which is leading the development of ImmuPharma's lupus drug