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The local oxygen therapeutic unit developed by Advanced Oxygen Therapy Inc. features better diabetic wound healing and reduced amputation and is used to expedite diabetic wound healing. We would like to know what the impacts on the market for ON101 are.
One of the causes of DFU is lower limb angiopathy, which leads to ischemia and hypoxia of the feet. When the local partial pressure of oxygen is below 30 mmHg, wounds do not heal easily, and chronic diabetic foot ulcers occur. As such, oxygen supply is often considered to be conducive to wound healing.
Hyperbaric oxygen therapy was the most commonly applied in the past; it, however, requires expensive equipment and venues and cannot be done at home. A local oxygen therapeutic unit is a simplified portable machine that can be used at home. However, after either hyperbaric oxygen or local oxygen therapeutic unit, wounds still require a drug that can effectively contribute to wound healing. The oxygen therapeutic unit is not a drug and hence is not a competitor to Fespixon. Just like artificial skin, it can be used as needed for actual treatment at the physician’s discretion and aims to expedite wound healing of patients.
Recent competitors to SNS812 in Mainland China with similar preventive effects against COVID-19, which is under investigation now, include the following:
F61 nasal spray, HY3000 nasal spray, and aerosol inhalation FB2001, among others.
They have entered Phase II testing and have been approved clinically. Are you aware of said three drugs and does our SNS812 have a competitive advantage?
An antibody or polypeptide is used in the nasal spray developed in Mainland China. Such drugs tend to be affected by viral mutations and be eliminated out of the body through nasal discharge and hence require frequent dosing and they do not apply to the various types of viral variants. In FB2001, a protease inhibitor similar to Paxlovid is used. By the same token, it is associated with susceptibility to viral mutations.
SNS812 is a small nucleic acid new generation drug of that differentiates from a protease inhibitor and targets the viral replication gene. The replication gene of the coronavirus since SARS in 2003 has not changed and hence it will not be easily affected because of viral mutation. It is the drug with the highest viral coverage that is under research and development at the moment.
Dr. Armstrong mentioned that the small-molecule HIF-1 αstabilizer can expedite diabetic wound healing and that Desferrioxamine-Laden silk nanofiber hydrogel can be injected to expedite diabetic wound healing. Are these two products commercialized yet? What are their impacts on ON101?
(1) Deferoxamine (DFO) is an old drug that has been available on the market for half a century; it is proven to be capable of contributing to neovascularization while tissues recover by stabilizing the primary regulator HIF-1α; it has, however, not been actually used in the treatment of diabetic foot ulcers.
(2) The clinical Phase 1/2 trial of DFO was originally designed to enroll 48 patients with rare sickle cell leg ulcers instead of patients with diabetic foot and the trial was canceled before the first subject was recruited; in other words, its efficacy has not been qualified.
(3) ON101 is an innovative R&D new drug with international multi-center Phase 3 clinical evidence available from patients with diabetic foot; the efficacy is significant and the data are already released in international journals.
“The anti-COVID-19 nasal spray developed in Thailand was released to the market in October; VAILL CITITRAP Anti-Cov Nasal Spray is produced by Hibiocy, a subsidiary of Rojukiss International;” what will be the strengths of SNS812, which is also planned to be an inhaled preventive agent for the future?
VAILL CITITRAP is currently only available in Thailand and there are no clinical evidence-based reports released so far. According to the public information provided by the manufacturer, its active ingredient is hypromellose, a viscose polymer that is often used in food additives or as excipient in oral agents; it is not anti-viral. The developer, however, believes that it can form a protective film in the nasal cavity to stop the virus from invading epithelial cells.
SNS812 is a broad-spectrum drug developed targeting the coronavirus RNA and can completely remove the viral RNA; multiple in-vivo anti-viral experiments have been completed and demonstrated its significant preventive and treatment effects on major types of the coronavirus. It is now in Phase I clinical trials as required by the laws and regulations governing the research and development of drugs.
https://whoniz.com/en/en-iypoly-en/
At present, we have seen some Korean pharmaceutical company with sprayed formulation to help prevent against COVID-19.
Besides the Korean certification, it is registered with the FDA OTC.
We would like to know if you have done any research about this competitor as to whether it will impact SNS812; if IND begins for 812, do you also suggest that the medical device procedure may be followed for SNS in order to speed up the marketing process? Thank you.
IYPOLY is a product jointly developed by Korea and Japan and is Immunoglobulin Y (IgY) extracted from chicken eggs. This technology has been in existence for decades. In the beginning of the pandemic, laboratories in multiple countries already tried to apply it to the coronavirus, with publications released. For all the anti-COVID-19 IgY studies released so far, only in-vitro virus neutralization testing has been done; no data of its efficacy in animals and humans are available.
IYPOLY was marketed in the US as an OTC product. The manufacturer stated in its disclaimer that most OTC products are not reviewed and approved by the FDA and are allowed to be marketed as long as they meet regulatory requirements and are in line with policies. The FDA does not evaluate if they comply with applicable requirements. In addition, this product is intended for “helping prevent against and minimize the invasion of infectious viruses to the respiratory tract;” it is disallowed to claim the capability of preventing against and/or treating COVID-19. In other words, comparison is impossible in terms of technology, indication, or market value.
I know you are busy but I would like to know the control to ON101 is the medical material Aquacel that is often used in the clinical setting. Suppose that the estimated time to healing for the two is 64-80 days and the estimated amount of the drug to be used is 2-7 tubes, with proper control, besides statistical significance in wound healing, I am more concerned about whether these two are competitive in terms of their price given the said treatment cycle.
1. Besides dressings, for the clinical treatment of DFU, different options will be added as needed, including hyperbaric oxygen, negative pressure, artificial skin, surgery, cell therapy, etc. Costs incurred from the treatment are not just about dressings.
2. Analysis results of the data submitted in the application for National Health Insurance coverage so far show that Fespixon is obviously more cost-effective and have the treatment strengths compared to the standard of care that is currently available.
Hi, we would like to ask the following two questions.
1. We have noticed that you are carefully evaluating whether or not to conduct Phase III clinical studies of radiation dermatitis. It is found that KeraStat Cream (K192386) approved through FDA 510(K) is also meant to treat radiation dermatitis. We would like to know if you have evaluated Fespixon versus this product applying the substantially equivalent (SESE) criteria and what are the strengths of Fespixon in terms of its efficacy in “radiation dermatitis” as compared to this product or any product released by other international pharmaceutical companies?
2. For SNS812, a pre-IND meeting has been held with the US FDA. Defined requirements and waivers are in place. Does it mean that the FDA recognizes and expects relatively highly of SN812? Have other pharmaceutical companies expressed any interest in collaboration so far? This drug is developed through joint R&D efforts of Microbio Shanghai. Given the relatively serious pandemic in Shanghai now, will it affect the progress?
1. A main ingredient of KeraStat Cream is the keratin in addition to other ingredients such as glycerin, mineral oil, and dimethicone, 11 total. Fespixon is composed almost completely differently from KeraStat Cream and hence cannot be introduced to the market in the substantially equivalent way.
Fespixon can transform the wound micro-environment, facilitates infiltration of the wound by repairing macrophages, and repair wound tissues. It novel mechanism of action and proactive wound-healing action are not comparable to ordinary humidifying products.
2. The FDA, in its opinions provided during the pre-IND meeting, approved the waiver of some pre-clinical trials of SNS812 and proactively and specifically gave multiple advice about its development. In other words, the FDA did show some positive attitude. Due to the fact that SNS812 is still at the pre-clinical R&D stage, to expedite its development, action items are primarily outsourced and are ongoing as scheduled for the time being.
How will FB825 cope with the competition from IL4 receptor, IL13, and JAK inhibitors in the treatment of atopic dermatitis?
Faced with the competition from IL4/IL13 antibody drugs, FB825, known for its treatment cycle of one dose every 4-12 weeks, can compete with IL4/IL13 antibody drugs that are given once every 2-4 weeks. In the exploratory clinical trial completed in Taiwan, FB825 demonstrated outstanding results in terms of efficacy and safety, with superior data compared to other antibody drugs and JAK inhibitors. Atopic dermatitis, in particular, is a chronic disease that relies on persistent medication; therefore, the safety of the drug used is critical to the patients.
Will SkinTE challenge the position of Oneness Biotech on the DFU market since the Company released results of the clinical trial in February this year through the article entitled “SkinTE® Met Primary and Secondary Endpoints in Multicenter, Randomized Controlled Trial in Venous Leg Ulcers”.
1. SkinTE® is an autologous cell therapy. The cell needs to be collected from other parts of the patient’s skin and be cultured before it is transplanted to the affected area. As diabetic patients often have skin lesions and the condition varies from one person to another, the actual efficacy is pending observation. The product was marketed in 2017 as HCT/P (human cells, tissues, and cellular and tissue-based product) for treating wounds; it needs to be refrigerated at 1-100C.
2. SkinTE® is an exploratory trial in VLU, with 14 subjects in the study group and 15 in the control group. Clinical efficacy and safety are pending sufficient verification for the time being.
3. Cell therapies are relatively expensive.
Hi, we would like to ask the following questions.
The US FDA recently approved Tezspire, a drug jointly developed by AstraZeneca (AZ) and Amgen and claimed to be the first and the only biologics that can persistently and significantly reduce disease progression in a variety of serious asthma groups. We would like to know if it also works in neutrophilic and mixed granulocytic severe asthma groups that are targeted by FB704A? If yes, is FB704A or even FB825 (allergic asthma) competitive?
In terms of mechanism, TSLP is also involved in eosinophilic and neutrophilic inflammatory response. Due to the fact that clinical trials targeting neutrophilic asthma is yet to be performed of Tezepelumab, however, the actual clinical effect cannot be determined for the time being.
As is indicated in a clinical effectiveness evaluation report (SOURCE), compared with other drugs treating asthma, such as omalizumab and dupilumab, for chronic patients who have relied on oral corticoid steroid (OCS) over the long term, treatment with tezepelumab did not significantly reduce the amount of OCS used by Week 48 versus the placebo. In addition, despite the fact that tezepelumab can improve the annualized asthma exacerbation rate (AAER), its effect on reducing daily flareups is limited. Asthma is a long-term chronic condition whose treatment demand is to reduce daily flareups and also the dependency on systemic corticoid steroid. The two new asthma drugs of Oneness Biotech remain promising in terms of their efficacy. The actual benefits, however, depend on clinical results.
FB704A is a first-in-class drug treating serious neutrophilic asthma that is available at present and a first biologics targeting this population; it is in a leading position. With its unique inhibiting action on the IgE B cell, FB825 will be differentiate from existing products in the future on the market for asthma treatments given its new mechanism and long-term safety. Both new antibody drugs are likely to gain competitive advantages in terms of precise choice of patients, reduced chances of daily asthma flareups, and reduced dependency on steroids.
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