HELIXMITH

DPN phase 3 anomalous PK investigation

작성자 helixmith 작성일 20-02-18 09:28

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Last September, Helixmith reported that PK anomalies were observed in the VM202 DPN Phase 3 trial, which raised speculation about the possibility of a mix-up of materials between placebo and active treatment groups. We have now investigated this possibility, root causes for the PK anomalies have been identified, and the investigation confirmed that there was no placebo-drug mix-up among the study subjects. A summary of the investigation process and results is as follows:

1. The company set up investigation teams in the US and Korea in October last year to investigate the possibility that some of the subjects randomized to receive placebo were dosed instead with VM202, and that some of the VM202-designated subjects received placebo.

2. The investigation process began by examining study-related documents from all parties involved, including those involved in production, formulation, and labeling of the investigational products, inventory storage, generation of the randomization codes, shipping to 25 clinical investigation sites, coding (blinding) for treatment of individual subjects, intramuscular (i.m.) dose administration at each of the 25 clinical sites, PK blood sampling at up to 14 time intervals from the 500 enrolled subjects, processing and labeling of over 6,500 individual blood and serum samples, shipment of blood and serum samples to the bioanalytical contractor, and subsequent bioanalytical analysis and unblinding of the results.

3. The contents of the unused or returned drug supplies were analyzed chemically by Helixmith directly or by a specialized CRO to determine whether they contained VM202 or placebo according to the randomization schedule.

4. The results gave us a clear picture of several causes that we believe contributed to the PK anomalies that were found in September last year.

5. The investigation confirms that there was no evidence of placebo-drug mix-up among any of the 500 subjects in the DPN 3-1 study. In other words, it is judged that subjects in the placebo group never received VM202, or vice versa.

6. The results gave us a picture of several causes that we believe contributed to the PK anomalies that were found in September last year. Helixmith is assessing appropriate remedies with any involved parties, and is in the process of taking steps to prevent the recurrence of similar incidents in any future clinical studies.
Based on the above investigation, and despite the causes referenced above, we were able to validate the results of the DPN 3-1 clinical trial. Going forward, we have identified quality improvement procedures that we are implementing in follow-on Phase 3 clinical studies that we will initiate this spring. The top-line results of our investigation will be announced shortly through the company's official channels.