Lupuzor™ Update30th September 2022 - 2:23 pm
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, provides an update on Lupuzor™, following the Company’s recent announcement on 14 September 2022, that its US partner for Lupuzor™ (P140), Avion Pharmaceuticals (“Avion”), had received a written response from the Food and Drug Administration (“FDA”) to the Type C meeting.
In summary, the FDA response earlier this month, recommended assessing the potential to use higher dosing in the next clinical program of Lupuzor™ in Lupus, to optimise the clinical benefit to Lupus patients and to maximise efficacy. In addition, the FDA made additional recommendations on clinical measurements, again to support Lupuzor™ through the regulatory process to approval.
Since then, both ImmuPharma and Avion, with their clinical and regulatory teams and advisors, have been reviewing in detail the FDA’s written response and recommendations.
Further details on the next steps for Lupuzor™ will be communicated to the market, once finalised between ImmuPharma and Avion.
Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma said:
“Following receipt of the FDA letter earlier this month, we welcome the helpful recommendations from the FDA on the next steps in the Lupuzor™ clinical program. We equally recognise shareholders’ frustrations on what is a very complex regulatory process, which is having an impact on moving Lupuzor™ forward. However, we are working very closely with the clinical and regulatory teams at Avion to accommodate the FDA’s recommendations and decide on the next steps. We will update the market as soon as we have further guidance to share.”
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.