LONDON - Phytopharm plc disclosed results of two U.K. Phase III trials of Zemaphyte, its botanical for the treatment of acute eczema, and said it is stepping up efforts to license this and other plant-based pharmaceuticals in its portfolio.
The Phase III results are positive, but they were carried out before the company had its Good Manufacturing Practices (GMP) production facilities in place. The U.K. Medicines Control Agency has told Phytopharm it will not consider a resubmitted product license application until the results of a U.S. Phase II multicenter trial, carried out with GMP-manufactured Zemaphyte, are available.
The problem is that the trial has not started yet, and the company does not have sufficient funds to finance it and keep the rest of its portfolio moving forward.
CEO Richard Dixey told BioWorld International, “We are going into a licensing phase. Zemaphyte is our lead product, but at the same time we will not bring the company to a halt just to develop Zemaphyte.“
In recent months, Phytopharm, of Godmanchester, U.K., has had discussions with a number of pharmaceutical companies, which have expressed strong interest in other products in the portfolio. Dixey said these have substantial commercial potential, and the decision was made to continue their development, using funds currently available.
“The aim is to maximize licensing income as early as possible, rather than putting further funds into the development of Zemaphyte,“ he said.
The first, 10-hospital Phase III trial of Zemaphyte recruited 150 patients, between three and 67 years old, attending outpatient dermatology departments. These patients, with moderate to severe eczema that was unresponsive to current treatments, were treated with Zemaphyte for up to 20 weeks. At the 12 week assessment point there was a significant reduction in eczema scores, including a median reduction in skin damage of 52 percent.
The second study, at Great Ormond Street Hospital, in London, recruited 37 children aged 3 to 15 with eczema refractory to current therapy. After eight weeks of treatment with Zemaphyte, there was a mean reduction in surface damage to the skin of 41 percent, compared with 10 percent for the inactive placebo. A similar improvement was seen in skin redness. The difference was statistically and clinically significant.
Dixey said, “We are very pleased with the results, and keen to try and find a licensee before the U.S. clinical trial. We want the licensee to be involved now - we don't want to find the trial is not suitable.“
The company is facing the added complication of blazing the trail as it aims to become the first to get a botanical registered as a pharmaceutical. In 1997 it was granted the first investigational new drug application in the U.S. for a botanical product.
Dixey estimates the U.S. Phase II trial will cost $2 million; at present the company has £4 million to £5 million in cash. “We ought to have £10 million to £12 million in the tank at any one time.“
Negotiations on other products in Phytopharm's portfolio, including treatments for obesity, inflammatory diseases and neurological disorders, are more advanced than those on Zemaphyte. Dixey said these are likely to be licensed before Zemaphyte. Once any license is granted, the company also plans to raise more money from investors. *