Antibe Therapeutics Inc. announced that its Otenaproxesul’s Phase III preparations remain on schedule. With eight Phase III-enabling animal studies finished and a further two to complete, it have already discharged the bulk of registration trial preparations begun last summer. it also remain on track with CMC (chemistry, manufacturing and controls), an extensive set of activities crucial to late-stage clinical development and commercialization. Its manufacturing partner is in the final stages of tablet production. As planned, it will be submitting otenaproxesul’s IND (Investigational New Drug) application to the U.S. FDA within weeks. In ordinary circumstances, it would then expect to proceed with the adaptive Phase III trial in the upcoming quarter. However, the ongoing rise in COVID-19 infections is increasingly compromising the ability of clinics and hospitals to accommodate large clinical trials, particularly in the U.S. where this trial must take place. With this situation expected to ease later in the year as vaccines take hold, guidance for trial initiation is being adjusted to the second half of 2021. In the interim, and supported by its strong balance sheet, it is taking the opportunity to perform an enhanced version of the previously planned absorption, metabolism and excretion (AME) study which is set to begin in Canada this quarter. In addition to providing valuable information for potential partners, this 6-week study (which includes 2 weeks of follow-up monitoring) will further de-risk dose selection for Phase III program, while also supplying pharmacokinetic data required for drug marketing approval. pipeline’s value and depth continue to grow. Last quarter, it commissioned a market opportunity assessment to guide the detailed development of second drug, ATB-352, an opioid replacement aimed at the post-operative pain market. The study provided important input for trial design and confirmed the large unmet medical need for a gastrointestinal-safe NSAID for acute pain, projecting peak year sales exceeding USD 800 million in the U.S. alone. While stronger nonsteroidal anti-inflammatory drugs (NSAIDs) have demonstrated analgesic efficacy comparable to opioids in many settings, they are correspondingly more damaging to the gastrointestinal tract, limiting their use and leaving physicians, payors and policymakers with few options as they address a resurgent opioid crisis. Leveraging hydrogen sulfide platform beyond its current focus on NSAIDs, its pipeline expansion initiatives are now generating promising new molecules and fresh intellectual property. Its first candidate for in vivo testing targets inflammatory bowel disease (“IBD”). More than three million U.S. adults suffer from this condition, long in need of safe and more effective first-line treatments. Previous work with hydrogen sulfide-releasing substances has shown encouraging results in animal models of IBD. The development of new molecules is an ongoing process and it hope to announce further progress in the coming months.