ADDED
The proportion of ibezapolstat-dosed subjects with an AE was similar to placebo at each dosing level.
Phase 2a results were published in CID (October 2022) and Phase 2b results were published in Lancet Microbe (June 2025).
Explanation of the mechanism of action of DNA polC inhibitors was published in Nature Communications (October 2025).
Following the ternary binding hypothesis described above, Torti et al.
Leiden University Medical Center/Health Holland Research Project In August 2021, Health Holland awarded a grant of approximately $500,000 USD to Leiden University Medical Center ( LUMC ) to further study the mechanism of action of pol IIIC inhibitors in a consortium partnership with our Company (the Health Holland Research Project ).
This constitutes a 100% response rate for the primary and secondary endpoints of the trial.
In the case of some products for severe or life-threatening diseases, such as cancer, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.
The FDA also may inspect the sponsor and one or more clinical trial sites to assure compliance with GCP requirements and the integrity of the clinical data submitted to the FDA.
Additionally, ibezapolstat drug substance is stable for at least four years and can be stored/transported in large quantities, allowing for strategic stockpiling.
Commercial supply of RSMs (Regulatory Starting Materials), DS and DP will be made in the United States.
REMOVED
Systemic exposure following oral dosing was very low and no accumulation occurred after ten days of repeated dosing.
The hypothesis supporting further development of ibezapolstat is that dGTP analog compounds bind to pol IIIC via a base-pairing domain and an enzyme-specific aryl domain ( Figure 1 ).
Pre-Clinical Studies All IND-enabling preclinical studies for ibezapolstat have been completed, including FDA-required toxicology, pharmacokinetics and in vitro microbiology studies and in vivo animal models.
The SAB noted that 10 out of 10 patients enrolled in the Phase 2a trial reached the Clinical Cure endpoint, defined in the study protocol as the resolution of diarrhea in the 24-hour period immediately before the end-of-treatment that is maintained for 48 hours after end of treatment.
All clinical trials must be conducted under the supervision of qualified investigators and in accordance with protocols detailing the objectives of the study, the parameters to be used in monitoring the safety and effectiveness criteria to be evaluated.
Assuming successful completion of the required clinical testing, the results of the preclinical studies and clinical trials, along with information relating to the product s chemistry, manufacturing, and controls and proposed labeling, are submitted to the FDA as part of an NDA requesting approval to market the product for one or more indications.
Additionally, we can extrapolate to 48-months stability per FDA Manufacturing Guidance in advance of a 48-month pull point to occur in the first half of 2024.
The selling price estimate of $3,000 to $3,500 is considered by management to be conservative as it is well below the price point of fidaxomicin, the most-recent approval in treating CDI which we believe is between $4,500 and $5,000 for a full course of treatment.
We believe the size of the market and relatively few treatment options available will drive our market capitalization and availability of financing alternatives as it completes Phase 2 clinical trials successfully.
The competition for ibezapolstat include the following: Several pharmaceutical companies have established themselves in the market for the treatment of CDI and several other companies are developing investigational antibiotics for the treatment of CDI.