Biotech Values

[DewDiligence]

Repligen’s Secretin bombs again

[A little over a year ago, Secretin failed to show a significant benefit in a pivotal trial autism. Now the same has happened in a phase-2 trial in schizophrenia. A Secretin trial is underway in ADHD and I would wager that trial will fail also.

Secretin seems to be a textbook case of a drug searching for an indication. Apropos to Zebra’s post some time ago, RGEN will probably continue to run trials and squander shareholder equity in the desperate hope that something will work. Indeed, this PR even implies such a course of action.]

http://biz.yahoo.com/prnews/050204/nef006_1.html

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Repligen Reports Initial Clinical Data for Secretin in Schizophrenia

Follow-on Study Planned to Target a Cognitive Deficit of Schizophrenia

WALTHAM, Mass., Feb. 4 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN - News) today reported initial results for a Phase 2 clinical trial of secretin in refractory schizophrenia. The analysis indicates that secretin did not produce a statistically significant improvement in patient symptoms as measured by the Clinical Global Impression (CGI) or the Positive And Negative Syndrome Scale (PANSS). There were no serious adverse events in the trial.

The Phase 2 trial evaluated 4 intravenous doses of secretin vs. a placebo over two weeks. Patients were assessed at baseline and six times during the treatment period with several psychometric instruments including the CGI and the PANSS. There were a total of 44 evaluable patients who received either placebo (n=15), secretin at 2 CU/kg (n=15) or secretin at 5 CU/kg (n=14). The mean change in CGI in the secretin group was not significantly different than placebo. In a responder analysis, a CGI responder was defined as a rating of "Very Much Improved" or "Much Improved" in at least four of the six evaluations during the treatment period. There were 2 responders (13%) in the placebo group, 3 responders (20%) in the low dose secretin group and 4 responders (29%) in the high dose group; however, this trend was not significant given the low power of this study.

There was not a significant treatment effect documented with the PANSS positive symptom sub-scale or the PANSS negative symptom sub-scale. In addition to positive and negative symptoms, the PANSS items were also analyzed for dysphoric mood, activation/aggression and autistic preoccupation. There was a trend towards improvement on the dysphoric mood scale (anxiety, tension, etc.) in the secretin group (P=0.06).

Several clinical investigators reported transient changes in the social interaction of patients at the time of the infusion. We intend to gather additional observations from the sites prior to unblinding site personnel to better understand these observations. In addition, several patients participated in a cognitive testing paradigm within two hours of the first dose to assess the impact of secretin on one of the cognitive deficits characteristic of patients with schizophrenia. The results suggest that further investigation of this symptom is warranted. We are currently discussing the design of a follow-up study to determine if this observation is reproducible and related to drug treatment. [It probably isn’t!]

The Phase 2 study was designed to confirm the results of a Phase 1 trial of secretin in schizophrenia which was carried out independently by investigators at the University of North Carolina. In that study, 22 patients with refractory schizophrenia received either a single, intravenous dose of 1 or 2 CU/kg of secretin or a placebo. Several patients in the secretin group had marked, but transient improvements in symptoms compared to none in the placebo group. The secretin group was significantly more improved than the placebo group as judged by Clinical Global Impression scores at 3 and 7 days after treatment. In a CGI responder analysis, 3 of 11 patients (27%) in the secretin group were rated as responders compared to none in the placebo group. No differences between the groups were observed in the PANSS evaluation one week after treatment.
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