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Response to shareholders’ question about the diabetic foot ulcer clinical trial
관리자
2021/09/10 9126

Please refer below for answers to shareholders question about the diabetic foot ulcer clinical trial.


1. Efficacy Analysis Set: There were number of questions on whether or not to include two subjects who met exclusion criteria in the efficacy analysis set.


Answer: According to international guidelines, the analysis of clinical trial data should be performed on two analysis sets; 1) a group of patients who have been enrolled and received an investigational drug at least once (mITT; modified intention-to-treat) and 2) a group of patients who have been enrolled, received an investigational drug AND did not have major protocol violation (PP; per protocol). In general, for clinical trial where superiority is required to be demonstrated against placebo, primary analysis set should be the mITT set. By the definition, for DFU-301 study, patients who meet the exclusion criteria which suit the definition of major protocol violation, will be excluded from PP set but will be included in mITT set.


2. DFU-301 top-line result announcement schedule: There were questions asking exact top-line result announcement schedule as it is often said that the bio-company do not usually discloses top-line result on the target date and the results are always announced later than promised date.


Answer: It is bitter to hear that. We believe those of you who work in the bio industry may have full understanding on possible causes of delay and the fact that time required in data cleaning and performing analysis to have top-line result is very unpredictable.


Completing clinical trial and having top-line result announcement on the target date (NOT promised date) are not solely depending on devoted work of company"s employees. Study investigator, research coordinators, and contracted data management and stat. team must collaborate in collecting, reviewing, correcting and finally completing the clinical study data to draw efficacy and safety conclusions. Especially when it comes to phase 3 study where number of hospitals (clinical study conducting sites) are involved, it is even harder to finalize the clinical study data by the target date, as delay from one clinical study conducting site will inevitably impacts the overall timeline. In addition, If an event found during data cleaning requires approval of the ethics committee, it also causes delay yet it is impossible to predict this delay until it actually happens. In this context, many bio/pharma companies seems to disclose top-line results later than the target date (not the promised date). Like all other clinical studies, situations like aforementioned happens in DFU-301 as well, but definitely company is putting all time and effort to abide by the target date.


3. Questions about clinical trial results:


Answer: Until the analysis is completed, the company cannot know the results, and we are waiting for the results with the same sentiments as shareholders. There were also questions asking companys thought on whether or not DFU-301 result will

demonstrate statistical significance or not, in comparison of the results of phase 2 . We believe calculating success probability on arbitrary assumptions do not have real value, but requires time and effort of the clinical team who will otherwise focus on clinical study data cleaning.


4. The primary goal of the company DFU project is to develop a good drug for diabetic foot ulcer. By developing promising treatment of diabetic foot ulcer, the company would like to provide good treatment option to the patient, as well as repay the shareholders who have trusted and invested in Anterogen"s value.


Anterogen is conducting clinical trials of DFU-301 (Wag 1 & 2) and DFU-302 (Wag 2) to achieve the goal of developing a good treatment for diabetic foot ulcer.


As shareholders know, the initial plan was to file a NDA(New Drug Application) after completing both clinical trials of DFU-301 and DFU-302. Only in case when the DFU-301 clinical trial alone yields statistically significant results similar to phase 2 clinical trial, the company will file an NDA with DFU-301 data alone as the company have repeatedly said.


If DFU-301 shows good results and company is able to submit an NDA for market approval with one clinical trial, it is a huge achievement and happiness to company as well as to shareholders. But even if DFU-301 does not demonstrate statistically significant results primarily owing to not sufficient number of Wag 2 patients enrolled in DFU-301 study, the company still can prove the efficacy of the drug with DFU-302 study, as initially planned. The true value of Anterogen shall be remained as it is and was.

 

Disclaimer: All information expressed herein are intended to provide answers to the shareholders questions. Although best efforts are made to ensure that all information is accurate and up to date, occasionally unintended errors may occur. Each Individual is responsible for all the risks and financial resources that you use and chosen in stock investment to our company.