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ImmuPharma (LON:IMM) revealed that Lupuzor's registration with the US National Institutes of Health's ClincialTrials.gov web site has now gone 'live'.
The specialist drug discovery and development company said the milestone is confirmation of Lupuzor's pivotal Phase III trial protocol and the current clinical commencement and completion of the study.
Lupuzor is ImmuPharma's lead compound for the treatment of Lupus, a chronic, potentially life-threatening autoimmune disease.
Speaking to Proactive Investors, ImmuPharma's chief executive Dimitri Dimitriou said confirmation of the registration was not unexpected, but it does remove any small element of nagging doubt that shareholders might have had.
Dimitriou said a lot of groundwork has already been put in place ahead of the start of the Phase III trial.
Phase III is the stage of testing where a drug or treatment is given to large groups of people to confirm its effectiveness, check for side effects and benchmark it against commonly used treatments for the same disease, and is an exciting, albeit nerve-wracking phase for any drug development company.
Dimitriou explained that Phase III is a bit of a loose term, however.
“It's like building a house. You don't start laying bricks first; you have to lay the foundations – in fact, before you start laying the foundations, you have to dig.”
In the case of a phase III trial, the company and its partner, clinical research organisation (CRO) Simbec-Orion, have had to recruit the appropriate medical centres to perform the tests, train the medical staff at the centres, and then the doctors have to start screening the patients., according to enrolment criteria.
“You can't just recruit any patient, you must find ones that meet the criteria for the study, because, for example, the key end-point [of the study] is reducing the Lupus score by four points; in other words, you can't recruit a patient who only has a score of two,” he explained.
So, the message is, that even when things appear to have gone quiet on the testing front in terms of news flow, the company is, in fact, working hard in the background.
The AIM-listed firm added it has signed a term sheet with a US investor for a proposed placement of shares to finance the clinical trial.
The initial instalment of funding consists of a convertible loan of US$2mln plus additional capital of up to US$12mln at the company's discretion, subject to certain criteria, over a two year period, which should be enough to cover a funding gap in the trial programme.
Further details of the funding will be released once the agreement has been signed off.
In the meantime, Dimitriou said the study is working well in terms of the preparations, and it remains a case of “watch this space”.
Shares in ImmuPharma were up 45 at 43.15p in mid-afternoon trading.