By Matthew Willett

Inspire Pharmaceuticals Inc. temporarily suspended enrollment in a Phase II trial of INS365, its candidate for treatment of chronic bronchitis, to further evaluate the trial¿s protocol.

Company officials said the protocol was termed ¿burdensome, problematic and unworkable¿ by site managers, due to the difficulty in efficacy assessment in elderly patients with chronic bronchitis, a debilitating disease.

INS365 is under development in partnership with Genentech Inc., of South San Francisco. Inspire, of Durham, N.C., entered the partnership with Genentech in December 1999. The collaboration, which included a $10 million up-front payment from Genentech to Inspire, was valued at $78 million at the time. (See BioWorld Today, Dec. 22, 1999.)

¿This was prompted by feedback from the joint project coordination team,¿ Inspire¿s chief business officer Greg Mossinghoff told BioWorld Today. ¿There has been a level of frustration in implementing the protocol, and because of that we decided to step in and review the situation and try to come to grips with the issues with the protocol that clearly isn¿t doing a good job in assessing those patients.¿

CEO Christy Shaffer said the next step is to assess the information the trial has produced so far, and after that assessment the companies will decide to go forward with a new protocol, stop the trial or initiate a new trial.

¿It¿s clear now that the protocol, which was designed by committee, is a very cumbersome and rigorous protocol for patients with chronic bronchitis,¿ Mossinghoff said. ¿The majority of the patients are elderly, and it will take time to look at the data and best determine how to design a protocol to meet patient needs.¿

Right now, however, it¿s too early to tell what will happen with the trial, which began dosing patients in January.

¿We¿ll be looking at the data very carefully,¿ Shaffer told BioWorld Today, ¿And we¿ll determine whether or not to continue with the existing protocol, with the protocol amended or to close out the study and initiate, perhaps, a newly redesigned protocol, but we can¿t determine that at this time.¿

What delay the suspension will produce, if any, is still a question as well, Shaffer said. Patients will, the company said, continue to receive treatment. Shaffer added that addressing the problem is better done early than late.

Shaffer continued, noting that the suspension won¿t have an effect on the other trials ongoing for Inspire. Mossinghoff said the company¿s goals for the chronic bronchitis program haven¿t changed.

¿The goal here is to come out with a very clear and good data set out of Phase II, so we can make a good decision out of Phase II and into Phase III,¿ he said. ¿We felt that the problems with the protocol, and the problems that we¿ve had with it, meant that we wouldn¿t have a good data set.¿

Shaffer maintained there is ¿still a very strong commitment by Inspire and Genentech for this program. We have a good working relationship with them. The other important fact is that this has not had an impact on our cystic fibrosis program with Genentech or our dry eye program. This is a company that has seven programs, four in the clinic and two moving into the clinic. This is an important project, but not our only project.¿

Inspire¿s stock (NASDAQ:ISPH) rose 25 cents Tuesday on the news, closing at $10.95.

No Comments