ImmuPharma PLC (AIM:IMM, OTC:IMMPF) said it welcomed the "helpful" recommendations made by the US regulator in written response ahead of the next clinical trial of Lupuzor, a treatment for the autoimmune condition lupus.
Lupuzor, also known as P140, is being taken through a final-stage study by ImmuPharma’s American partner Avion Pharmaceuticals.
As a precursor, it had what is called a Type-C meeting with the US Food and Drug Administration (FDA).
Following this, the FDA recommended assessing the potential to use higher dosing in the next clinical program of Lupuzor to optimise the clinical benefit and maximise efficacy.
In addition, the drug watchdog made recommendations on clinical measurements - again to support Lupuzor through the regulatory process to approval.
"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 programme,” said ImmuPharma chief executive Tim McCarthy.
“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."
The update came at the same time as ImmuPharma announced its interim results, figures that showed the drug developer made a loss of £1.7mln with the company investing £1mln into its research and development efforts.
A successful fundraiser in August provided the business with access to just over £2mln.
“The new fundraising, supported by existing and new shareholders, allows us to further invest in the other parts of our product portfolio, whilst being focused on preserving cash where required,” said CEO McCarthy.
“Moving forward, we remain focused on creating a robust and successful company that, with a diversity of assets, will build future value for our shareholders.”