LONDON - Cerebrus Holdings Ltd., which specializes in the discovery and development of treatments for central nervous system (CNS) disorders, has entered an agreement with Eli Lilly and Co. for the joint development of a novel 5HT1A receptor agonist for the treatment of delayed and anticipatory emesis associated with cancer chemotherapy.
Cerebrus has in-licensed the compound, CEB-1555, and will carry out clinical development through Phases I and II. Lilly, of Indianapolis, has an option to take back the compound on completion of Phase II and to complete development alone or in collaboration with Cerebrus. Otherwise, Cerebrus is free to complete development alone or with another partner.
“We have always said that we would consider in-licensing novel compounds which address unmet medical need in CNS disorders,“ said Andrew Smith, CEO of Wokingham-based Cerebrus. “The deal with Lilly arose as a result of ongoing discussions. CEB-1555, which Lilly was developing for another indication, was subject to re-prioritization.“
Smith said Cerebrus expects to spend between £3 million (US$5 million) and £4 million on the Phase I and Phase II trials, and to complete Phase II trials in two to three years. “In terms of its significance, this will sit alongside some of our other major investment programs,“ he said, noting Lilly is a “major CNS player.“
Emesis (vomiting) following chemotherapy is subdivided into acute, delayed and anticipatory. Acute emesis occurs within 24 hours and can be treated with 5-HT3 antagonists. Delayed emesis, 24 to 72 hours after treatment, is only partly treated by these drugs. Anticipatory emesis, a conditioned response occurring prior to second or subsequent treatment, is also resistant to existing therapies.
This response can prevent patients from completing the course of chemotherapy. “The market for a treatment for delayed and anticipatory emesis would be a substantial one, of hundreds of millions [in U.S. dollars],“ Smith said.
CEB-1555 was effective in inhibiting emetic stimuli in a number of animal models, and in contrast to 5-HT3 antagonists was effective against acute, anticipatory and delayed emesis. The compound also has shown potential in animal models of other CNS diseases, and has a safety profile suitable for progression into clinical trials. *