Last checked at 14 Sep 2022 10:04
14 September 2022
ImmuPharma PLC
("ImmuPharma" or the "Company")
Written Response received from the FDA
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, announces that, further to the Company's notification of 7 July 2022, its US partner for Lupuzor™ (P140), Avion Pharmaceuticals ("Avion"), has received a written response from the Food and Drug Administration ("FDA") to the Type C meeting.
The FDA response was detailed and included significant guidance on next steps for the clinical programme. This included advice on the dosing regime. In addition, the FDA also provided further significant guidance on the study protocol that can be amended to improve the regulatory outcome.
The Company is currently reviewing the written response with Avion and will make a further notification in due course.
This announcement contains inside information as stipulated under the UK version of the Market Abuse Regulation no 596/2014 which is part of English law by virtue of the European (withdrawal) Act 2018, as amended. On publication of this announcement via a regulatory information service, this information is considered to be in the public domain.
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About ImmuPharma PLC
ImmuPharma PLC (LSE AIM: IMM) is a specialty biopharmaceutical company that discovers and develops peptide-based therapeutics. The Company's portfolio includes novel peptide therapeutics for autoimmune diseases and anti-infectives. The lead program, Lupuzor™, is a first-in class autophagy immunomodulator for the treatment of Lupus and preclinical analysis suggest therapeutic activity for many other autoimmune diseases that share the same autophagy mechanism of action.
For additional information about ImmuPharma please visit www.immupharma.co.uk
ImmuPharma's LEI (Legal Entity Identifier) code: 213800VZKGHXC7VUS895.