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We would like to know, if the FDA approves direct use of SNS812 in patients, what will be the impact on SNS812 with the addition of a treatment group, the Ic group, during the trial by your company.
In the Phase I clinical trial of SNS812 that is currently ongoing, the evaluation is focused primarily on the safety and metabolism of the drug that is being evaluated in healthy people. The implementation is divided into two stages, single dose escalation (Ia) and multiple dose escalation (Ib).
In order to expedite the qualification of SNS812 in terms of its treatment efficacy in humans, Oneness Biotech plans to apply for the Ic trial with the US FDA once the safety data is obtained from Part Ia so that the safety of SNS812 can be tested among patients with COVID-19 and the treatment effects can be observed directly.
The Ic trial will take place right after Ib and there is no need to submit the IND application separately. Upon approval by the FDA, it may be used in patients with COVID-19 one quarter earlier to obtain drug efficacy data ahead of schedule, which is in favor of subsequent developments and the trial design.
Oneness Biotech and its international collaborators are jointly conducting the subsequent PK bridging study of FB825. We would like to know what the subsequent R&D plan for the study is?
A human PK bridging study is conducted for the sake of complying with regulatory requirements. Once the PK bridging study data is obtained, subsequent Phase IIb clinical studies will be designed on the basis of such data.
Hi~it is recently covered in news that BQ.1.1, BQ.1, and XBB are the three new variants found in Europe and America. Are these three variants within the protective scope of SNS812? Thank you?
For BQ.1.1, BQ.1, and XBB, 40, 44, and 10 viral strain sequences, respectively, have been released so far in the GIAID (global initiative on sharing all influenza data). The SNS812 coverage is 100%.
We would like to know if SNS812 has been tested with BF.7? Is the coverage still maintained at 99.8%?
The BF.7 variant is short for Omicron BA.5.2.1.7. For this viral strain, 853 viral strain sequences in total are available now in the GIAID (global initiative on sharing all influenza data). The SNS812 coverage is 100%.
For ON101, your company adopts the complete cure rate in clinical design as the endpoint. Why are you not adopting the wound healing rate instead? We browsed prior clinical designs of the Company. You target primarily foot wounds having gone through surgical debridement of diabetic patients. We would like to know why are you not focusing on superficial chronic wounds that have difficulty healing due to recurrent pressurization?
1. The endpoint of the Phase 3 clinical trial of ON101 is based on the US FDA clinical guidelines for chronic ulcers; the primary efficacy endpoint has to be the complete cure rate (ratio) of ulcers and it is clearly indicated that the wound healing rate cannot be adopted as the basis for clinical efficacy assessments.
2. Debridement is part of the standard-of-care procedure of diabetic foot ulcers. It can be done surgically and non-surgically. Debridement is to take place as needed for the design of a Phase 3 clinical trial. Included foot ulcer cases include “superficial chronic wounds that have difficulty healing due to recurrent pressurization” and deep chronic wounds.
Hi, we would like to know:
1. CRP was found as the biomarker during Phase 1 clinical trials of FB704A. We would like to know if exploratory trial drugs follow the same path?
2. With IV FB825, only one dose over a period of three months is needed to render the same effect as that of its comparator drugs. Are you confident that the same concentration can be guaranteed with the SC formulation?
1. CRP (C-reactive protein) is an inflammatory index; it is created by the liver and climbs with presence of inflammation in the human body. Causes of systemic inflammatory diseases vary and so do the types of cytokines that trigger them. IL6 is one such cytokine. In other words, an exploratory trial aims to find out which patients have the IL6 signaling pathway to spearhead their inflammatory response and these patients are the responders to FB704A.
2. Findings from experiments conducted among monkeys show that the bioavailability of SC FB825 is 86% that of the IV dosage form. Given the similarity, Oneness is confident that they can be smoothly switched mutually. Whether the SC dosage forms can render similar effects to those of the IV dosage form or not is pending verification following bridging studies among humans.
We would like to know:
1. For Phase IIb enrollment of B825, is it possible for the clinical trial to be a big win if effective response biological indicators are adopted as the enrollment criteria?
2. How will you avoid the various enrollment deviations in the future?
1. Based on the results of a Phase IIa trial, in one-third of the target populations, FB825 reached 53.8% in EASI 75 (improvement in atopic dermatitis by 75%, which is a primary efficacy endpoint of a Phase 3 clinical trial), with a difference of at least 20% from the control group; the results are similar to those of the two Phase 3 trials of the competitor drug Dupixent, with presence of dose strengths. Based on an overview of the consistency with the two exploratory clinical trials completed in Taiwan, Oneness believes that by enrolling patients in the target populations, FB825 shall be able to achieve clinical indicators.
2. Oneness clearly keeps track of the impacts of the pandemic or many other related external factors on the enrollment for clinical trials that deal with moderate to severe atopic dermatitis and is confident while ensuring that target patients are enrolled in the future.
Hi, we would like to know:
1. Will SC FB825 begin small-scale bridging studies in the clinical setting?
2. Will the concentration of the drug be explored in the case of subcutaneous injection?
3. Where are you now in related patents for companion diagnostics?
4. Will Biomarker Responders be adopted by international partners in subsequent clinical efforts for the screening of patients?
1. An SC bridging study is a small-scale clinical trial where a few healthy subjects are enrolled and the drug is administered subcutaneously and compared against the IV dosage form in terms of pharmacokinetics.
2. A bridging study aims to compare the pharmacokinetics of a drug administered subcutaneously versus the IV dosage form. As such, the blood level data of the drug will be obtained concurrently.
3. Accumulation of study data of biomarkers is ongoing. Once the data are confirmed, it will be decided whether or not to apply for patents of companion diagnostics.
4. Patients will be screened applying the same criteria for international comparator drugs.
1. For enrollment for the Phase 3 trial in the US to Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers, besides Olive View-UCLA, do you consider to add the Keck School of Medicine of the University of Southern California as a clinical trial institution?
2. How is EAP implementation of ON101 in the US?
1. Based on the evaluation of subjects recruited for Stage 1, the CRO screened new study sites concurrently. The choice of a study site requires evaluation on multiple fronts. The Keck School of Medicine of the University of Southern California is a key institution for DFU. Oneness already started collaboration with Professor David G. Armstrong, known for his international authority on DFU at the said institution, this quarter while evaluating study sites and providing advisory opinions on studies. Please refer to a summary of the presentation given in today’s Investor Conference.
2. The current status in the US primarily features Phase 3 clinical enrollment and secondarily the Expanded Access Program. Qualified patients are prioritized to be enrolled in the study so as to avoid impacting the enrollment and the subsequent NDA timeframe.
Hi, spokesperson, we would like to know:
1. About the ongoing Phase 2a trial of FB825, the Company mentioned in its material information in the beginning of last month the primary efficacy endpoints: changes in the EASI index and baseline at 16 weeks. For baseline indicators, besides TARC and IgE that were mentioned, what are the other indicators?
2. In the Phase 2 exploratory trial, did FB825 (anti-CεmX antibody new drug) primarily reduce the level of IgE to accordingly achieve the purpose of reversing AD?
3. The Company mentioned in material information that it is difficult to recruit subjects during the pandemic. In order to reach the target number of subjects to be recruited within a year, referral institutions are authorized to help with recruitment for this trial. More than 50% of the subjects enrolled are new patients from referrals. These patients do not have a medical history to help with more precise judgement about their condition. Atopic dermatitis in most of these patients was a multiple immune condition in nature and it affected the determination of the target populations at the time of enrollment. Use of immunosuppressants over the long term is common among patients in moderate to severe condition in the target populations. Immunosuppressants or immunomodulators, generally speaking, are third-line therapy of AD. We would like to know what are probably the inhibitors that you believe were used and hence affected biochemistry parameters such as IgE or TARC in the subjects?
1. Baseline indicators also include other disease indexes (SCORAD, vIGA-AD, DLQI, Pruritus NRS, etc.) and TH1/TH2-related cytokines.
2. FB825 renders efficacy not by neutralizing IgE directly. The target of FB825, CεmX, exists on the surface of IgE B cells that secrete IgE. FB825 acts to trigger apoptosis of IgE B cells and prevent against generation of additional IgE in the human body to accordingly break the vicious circle of allergic reactions and fulfill the goal in the treatment of AD.
3. Use of immunosuppressants over the long term is common among patients with moderate to severe AD; nevertheless, it is impossible to keep the condition under effective control. Publications and clinical results of other biologics show that such patients have higher baseline values of TARC/IgE. The blood biochemistry analysis after this trial was completed revealed that the baseline values of TARC/IgE of patients enrolled were lower than those in clinical trials of other competitors. The pandemic may have been the cause for the enrollment deviations of target populations and the lower baseline values of TARC/IgE.
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如何使用IE找到Microsoft Edge?