* Data not good enough to secure FDA approval - analysts
* BioCryst says 11 pct patients show partial response
* No patient achieves complete response in lymphoma trial
* Co says accessing feasibility of filing NDA
* Shares down 4 pct (Adds company comments, updates share movement)
By Anand Basu
BANGALORE, Sept 15 (Reuters) - BioCryst Pharmaceuticals Inc BCRX.O said only 11 percent of patients with a rare cancer of the immune system responded to its drug, forodesine, in a late-stage trial.
The data is not good enough to secure approval for the drug from the U.S. Food and Drug Administration, analysts said.
“In our opinion, 11 percent is on the low side of what the FDA would require for approval,” Ren Benjamin, an analyst with Rodman & Renshaw, said by phone.
Shares of the influenza-focused company were down 4 percent at $5.08 in late-afternoon trade Wednesday.
BioCryst is still accessing the feasibility of filing for marketing approval of forodesine, said Chief Medical Officer William Sheridan.
“We do believe it does have a chance of getting approved,” he added.
The numbers from the trial were small, but the results were a non-event for the company as it primarily deals with influenza, WBB Securities analyst Steve Brozak said.
BioCryst’s key influenza drug peramivir, which is in late-stage trials, had received an emergency-use authorization from the FDA.
“The most important thing will be Thursday’s presentation, where the company will give update on the influenza season and the use of their products overseas,” Brozak said.
On Wednesday, BioCryst said the main goal of the forodesine study was to show complete or partial skin response in patients with later-stage cutaneous T-cell lymphoma (CTCL) -- a cancer of the immune system that initially manifests as skin lesions.
The trial showed partial response in 11 percent of patients, while the disease remained stable in 55 percent. No patient achieved a complete response, the company said.
BioCryst also said interim results from a mid-stage study using forodesine as a treatment for chronic lymphocytic leukemia (CLL), a type of blood cancer, found partial response in three out of 25 patients.
Six patients remain enrolled in the study, whose main goal is overall response rate, the company said. Final results from this study are expected later this year.
“It’s a much earlier study (than CTCL) -- it shows some activity and that could be an indication for BioCryst to further pursue it,” Rodman & Renshaw’s Benjamin said.
Shares of the Birmingham, Alabama-based company have lost 14 percent since it reported a wider-than-expected quarterly loss on Aug. 5. (Reporting by Suzannah Benjamin and Anand Basu in Bangalore; Editing by Anthony Kurian, Vinu Pilakkott and Aradhana Aravindan)