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Is FB825 IIa AD already handed to the CRO for subsequent analysis?
In addition, when the injection method is changed from IV to SC, has the Company evaluated if the post-injected drug concentration will be affected?
Finally, once FB825 IIa AA is completed for Oneness Biotech, are there other subsequent collaborative projects on the indications with its partners?
1. For the Phase IIa clinical trial of FB825 in atopic dermatitis in the US, the primary efficacy endpoint visit has been completed for all subjects. Related data are being unblinded and analyzed by the CRO. Oneness Biotech will announce the analysis data as required once they become available.
2. The switch from IV to SC needs to be evaluated through a bridging study to facilitate subsequent clinical trials. Oneness Biotech has completed the evaluation in advance and it is confirmed that the bioavailability of the two dosage forms is similar.
3. Should the Phase IIa clinical trial of FB825 successfully meet the criteria, LEO Pharma will be fully responsible for the development of new indications through subsequent clinical trials and obtaining the new drug approval. LEO has begun to evaluate multiple potential indications and further exploration will be done depending on the evaluation findings. Oneness Biotech provides assistance in product knowledge.
Fespixon (ON101) will be in Phase III clinical trial for radiation ulcers, how does Phase III for this indication differ from Phase III for general new drugs? What is the estimated time required for this Phase III indication?
Radiation ulcers are skin ulcers resulting from radiotherapy of tumors, and are commonly seen in patients with breast cancer and head and neck cancer. Currently, there is no specific therapeutic drug available and there is a large market demand for it. At present, an exploratory clinical trial must be completed before a Phase III trial protocol and the number of subjects can be designed to determine the time required for the Phase III clinical trial.
As for the “scar” project, one of the ON101 medical, industrial and academic cooperation projects in the institutional investor conference, which kind of scar is it applied to? Is there any chance that ON101 can also be used in the medical cosmetology industry, considering the very smooth wound recovery of patients using ON101?
Currently, an academic clinical trial is planned to evaluate the efficacy and safety of ON101 in improving the scar beauty in patients after the thyroidectomy or caesarean section. Once the efficacy of ON101 is confirmed, it can be extended to the medical cosmetology industry.
Does Center for Drug Evaluation (CDE) evaluate FB704A by comparing its efficacy with that of similar drugs like Tocilizumab for patients with severe COVID-19 pneumonia? According to the CDE’s response, will the company conduct a phase II clinical trial of the antidote for patients with severe COVID-19 pneumonia in Taiwan?
1. When the phase II clinical trial of FB704A for patients with severe COVID-19 pneumonia was designed, Tocilizumab did not get approved by the EUA, but it is approved now. The U.S. National Institutes of Health (NIH) has recommended the use of Tocilizumab in combination with steroids in severe patients, and it is the same with those in Taiwan. In other words, the patients enrolled in the trial will not be steroid-ineffective patients, but those with severe COVID-19 pneumonia who have used Tocilizumab. This is related to similar drug effects repeated when FB704A is used after Tocilizumab and the best time to use anti-IL6 drugs. Oneness will choose head to head comparison of FB704A and Tocilizumab, or adopt the original plan in the future trial. At the same time, it is possible that after Investigational New Drug (IND) approval, Oneness will make a plan for FB704A, which has passed a Phase II IND approval, according to the epidemic situation to avoid waste of resources.
2. The CDE does not require comparison of efficacy with Tocilizumab in its advisory opinions, but guide the use of FB704A.
An assessment of venous leg ulcer (VLU) treated by Fespixon is performed. What are the assessment criteria? What kind of result is considered a success? What is the current progress?
The clinical trial of treating venous leg ulcer (VLU) with Fespixon performed is exploratory, which accepts subjects of C6 or C6R level based on the CEAP classification system. Its safety and potential efficacy during an 18-week treatment period will be evaluated. The trial center has been started, and subjects are being screened and enrolled.
What are the countermeasures and related response plans for the second Phase III trial of ON101 that the company plans to conduct in the United States against the Delta virus? Will relevant screening be carried out when the patient is enrolled or will it be assessed whether the patient has been vaccinated? In addition, whether the other hospitals for the patients in the company plans will be successively approved in the second half of the year?
1. If the patients are not screened for COVID-19 pneumonia when they are enrolled, the investigator of each trial center will assess whether the subjects are suitable for the clinical trial according to his/her medical profession and enrollment/exclusion clauses. During the trial, if there is a case of a subject infected with the COVID-19 pneumonia, relevant information will be collected and detailed in the medical record, and the investigator of trial will assess whether the subject is suitable for continuing the participation in the trial.
2. The international professional CRO commissioned for this clinical trial has formulated a complete response and handling mechanism for COVID-19. Once there is a need, both parties will draw up appropriate plans and strategies for the trial immediately.
3.Hospitals accepting the patients are being added according to the plan, and all will be started to enroll patients in 2021H2.
Has the efficacy of reusing Fespixon ever been tested for recurrence of the recovered DFU patients treated by it?
DFU is a dermopathy caused by angiopathy and neuropathy. DFU has a low incidence of complete wound closure and easy to recur after healing. It had a wound recurrence rate of 30% during the 12-week follow-up period after being cured by Regranex, the only DFU drug approved in the United States, in the Phase III clinical trial while the recurrence rate was 20.27% when Fespixon was adopted. If it recurs, the doctor can prescribe Fespixon to treat the wounds after assessment.
How about the current progress of the VLU safety test (ON101CLAS03) on the Clinical Trials Network in Taiwan?
In addition, how about the patent application progress of FB825 biomarker responder?
1.The VLU clinical trial is part of new curative effect exploration and mechanism of action trial of Fespixon. The trial center has been started and subjects have been recruited.
2. A provisional patent application of FB825 responder biomarker was submitted in November 2020. All trials of the biological index clinical research conducted in Taiwan were visited in June 2021, and the sample analysis is in progress. The test report is scheduled to be obtained in September 2021. With complete data collected, the formal patent application will be completed by November 2021.
1. When the first Phase III clinical trial of ON101 is carried out in Taiwan, China, and the United States, respectively, are the white people enrolled in the clinical trial? If yes, what are the relevant experimental statistics? Is there a significant difference between the Asians and the white people as trial subjects?
2. Is it common for “the drug efficacies to vary significantly among different races”? What are the possible causes?
1. In the first Phase III multinational, multi-center clinical trial of ON101 conducted in the United States, the subjects enrolled are all white people. The surplus between the ON101 group and the control group is 25%, which is equivalent to the surplus of the Asians enrolled in Taiwan and Mainland China.
2. The unique mechanism of action of ON101 is to adjust the performance of M1/M2 macrophages in the complete wound closure so that there is no significant difference due to race. As mentioned earlier, the first Phase III multinational, multi-center clinical trial of ON101 also showed that the incidence of complete wound closure between white people and Asians is comparably equivalent.
1. In addition to neutralizing and inhibiting the growth of IL6 to prevent the onset of cytokine storm, can FB704A be used to activate the body’s immune cells (such as NK cells)? In this Phase I clinical trial, are there any statistics available to show the difference?
2. If there are no statistics available, can it be added to the Phase II clinical trial?
1. According to a study published by an international journal, excessive IL6 can inhibit the activity of NK cells. After IL6-R blocking with antibody tocilizumab, the activity of NK cells can be increased (Arthritis & Rheumatology 2015, J Clin Invest. 2020). Theoretically, the blocking of the IL6 signaling pathway can increase the activity of NK cells. As the Phase I clinical trial of FB704A takes safety as the main indicator, NK cells were not observed in this phase.
2. In the upcoming Phase II clinical trial for the treatment of severe asthma, it has been designed to measure the relatively complete distribution of immune cells (including NK cells) in the bloodstream of the patients. This way, we can further understand whether FB704A treatment affects the patient’s immune cells.