BioWorld International Correspondent
LONDON - KS Biomedix Holdings plc has moved lead product KSB301 into a 400-patient Phase IIb trial in osteoarthritis, and said it will start a similar-sized Phase IIb study of its second product, KSB302, in rheumatoid arthritis within three months.
That will push the company's cash burn up from under £4 million in the financial year ending May 2001, to £6 million (US$8.7 million) in the following year. KS Biomedix, based in London, is aiming to find marketing partners to fund the Phase III development of KSB301.
Ian Miscampbell, chief financial officer, told BioWorld International, "The Phase IIa trial will finish before the end of 2001, and we will have the pivotal trial prepared and running next year. We are actively seeking marketing partners, and hope to have them on board by the middle of this year." The company is looking for regional partners, and may retain markets for itself.
KS Biomedix is not trying to partner KSB302 at present. "However, the product has generated a lot of interest and although we are not actively marketing it, people have been coming to us to find out about it," he said.
The two Phase IIb studies will cost between £1 million and £1.5 million each. "We believe doing the studies will add significant value over and above what we would have gotten if we chose to license out at the end of Phase IIa," said Miscampbell.
In Phase IIa, KSB301 demonstrated statistically significant improvement over standard therapy in a number of clinical endpoints. The Phase IIb trial will focus on pain control as the primary endpoint. KSB301, a small molecule, is also being explored as a disease-modifying agent in arthritis.
Progress has been slower than expected in the Phase I trial of the third product in development, KSB303. It is a super-high-affinity monoclonal antibody, which binds to the colon cancer antigen CEA. The first study, being carried out in Malaysia, is designed to demonstrate the prolonged retention of KSB303, and preliminary data are expected before the end of May.
KS Biomedix has licensed American rights to KSB303 to YM Biosciences Inc., of Ontario, Canada, in return for funding the development program. YMB will also provide three new targets against which KS Biomedix will create antibodies. The partners will share milestone and royalty payments on any products commercialized from the alliance.