BioWorld International Correspondent

LONDON - ImmuPharma plc disclosed highly significant results in a Phase IIa trial of IPP-201101 in the treatment of the chronic autoimmune disease lupus.

The company, armed with FDA fast-track status for the drug and an agreement on a Phase II/III trial design that will require only 150 patients, is looking for partners.

"The results are very good, and we plan to go full-steam ahead, alone or with a partner," CEO Dimitri Dimitriou told BioWorld International. "We are also going to arrange another meeting with the FDA to confirm fast-track status and trial design."

IPP-201101 is designed to modulate the immune system of lupus patients by modifying the activity of CD4+ T cells that are involved in the pathogenesis of the disease. Lupus is associated with enhanced levels of anti-dsDNA antibodies, and that was used as the surrogate marker of efficacy in the Phase IIa trial.

The proof-of-concept, dose-ranging study met its primary endpoints with anti-dsDNA antibodies decreasing in a dose-dependent way, with reductions of up to 47 percent in the level of the antibody. The drug was administered three times by subcutaneous injection two weeks apart, and the patients were monitored for one month after. There were no safety issues.

At a previous meeting the FDA told London-based ImmuPharma that IPP-201101 could be approved on the basis of a 150-200 patient Phase II/III study that confirmed the biomarker data translate into clinical benefit.

"We do need more funds to start Phase III, but it is a small trial, so it won't cost so much," Dimitriou said.

Lupus is a chronic condition in which patients experience flares of disease that can affect various parts of the body. It is treated with steroids, and to date there are no disease-modifying drugs on the market.

IPP-201101 was discovered by scientists at the Centre National de Recherche Scientifique in Strasbourg, France.

ImmuPharma has a license deal with CNRS and an ongoing research collaboration, and earlier this year was awarded a €1 million (US$1.3 million) grant from Anvar, the French Innovation Agency.

ImmuPharma was formed around a French company, Bio Delivery Systems SA, and a Swiss biotech, Zimmer and Associates AG. It joined the Alternative Investment Market in London in February 2006, through the reverse takeover of a shell company, General Industries plc. The listing raised £2.1 million (US$3.95 million). The company is 30 percent owned by the founding president and chief scientific officer Robert Zimmer.

There are two further compounds in the company's pipeline. IPP-102199, for the treatment of moderate to severe pain, is based on met-enkephalin, an analgesic that occurs naturally in the body. ImmuPharma says it is likely to have advantages over morphine of longer duration of effect and fewer side effects.

The other product, IPP-203101, is a treatment for methicillin- and other antibiotic-resistant infections. The compound delivers an electric charge that disrupts the bacterial cell wall, a mode of action that is expected to be difficult for bacteria to avoid through genetic mutation.

Dimitriou, who previously was senior director of worldwide business development at GlaxoSmithKline plc, with responsibility for deal making, said the two compounds are due to enter the clinic in 2007.

"After that the forward development plans will depend on potential partners and what we do with [the] lupus [drug]."