TORONTO--(BUSINESS WIRE)--Antibe Therapeutics Inc.:
To our shareholders,
Our achievements in the last twelve months have set the stage for a promising year ahead. With a cash position that provides more than two years of runway and fully funds the initial Phase III trial, we are adding value through comprehensive clinical development, ongoing partnering engagement and multi-pronged intellectual property (“IP”) advancement.
Otenaproxesul’s Clinical Development on Track
With the U.S. FDA’s recent clearance of otenaproxesul’s Investigational New Drug (“IND”) application and the requisite animal toxicology studies now complete, the receding COVID-19 pandemic is enabling us to solidify plans for our first Phase III trial. Involving approximately 750 patients, this efficacy trial is planned for approximately 50 sites in the U.S. and Canada, with enrollment set to commence in Q1 2022. The associated CMC (chemistry, manufacturing and controls) activities are on schedule, with drug tablet and placebo production well in hand by our global manufacturing partner.
Antibe is taking a comprehensive approach to maximizing the likelihood of a successful Phase III program outcome. We are currently evaluating proposals from leading global contract research organizations (“CROs”) with extensive osteoarthritis clinical trial experience; we expect to finalize our choice within weeks. The program also combines several state-of-the-art aspects, including the hiring of leading providers of bioanalytic, quality control and data management services. The latter will enable us to track and manage screening and enrollment in real-time, ensuring that the subject population matches trial criteria. To mitigate the risks that arise in the conduct of every placebo-controlled pain trial, we have contracted with one of the world’s foremost providers of clinic staff and patient education to ensure accurate and consistent reporting of pain scores and other measures. This firm will also provide us with real-time data during the trials, enabling us to make timely interventions if data quality issues arise – all without unblinding the trials. We have also retained a former chair of the U.S. FDA’s Advisory Committee on Anesthesia, Critical Care and Addiction Products for ongoing advice to ensure that our process meets FDA expectations for approving a novel chronic pain therapeutic.
We are also in the process of selecting three physicians to constitute the Independent Data Monitoring Committee (“IDMC”), a key de-risking aspect of the initial trial’s adaptive design. Favorably viewed by the FDA, adaptive design increases trial control and flexibility while maintaining statistical integrity. Once 50% of the patients in the trial have completed treatment, the IDMC will review the data, allowing for sample size increases to preserve statistical powering if needed. Achieving statistically significant superiority to placebo in this trial would be a major clinical milestone for our company. The balance of the Phase III program involves a second efficacy trial and a gastrointestinal (“GI”) safety trial. An additional efficacy trial will be required to provide data specifically for European and Asian regulators.
The Phase III program will be overseen by Dr. Joseph Stauffer, our Chief Medical Officer. Dr. Stauffer is a former analgesic and anti-inflammatory drug reviewer at the FDA as well as a pioneer in the design and conduct of adaptive analgesic trials, with experience as chair and member of several IDMCs. To support the expansion of our development activities, we continue to strengthen our team, including the recent hiring of Dr. Ana Stegic as our Director of Clinical Operations. Dr. Stegic is a medical doctor with more than fifteen years of experience in managing global clinical trials for large U.S.-based CROs.
In the lead-up to Phase III program initiation, we are taking the opportunity to conduct two smaller clinical studies to support our commercial, regulatory and drug development priorities. To be completed this quarter, we are conducting an IND-opening single-dose detailed pharmacokinetics/ pharmacodynamics study in 24 healthy volunteers at a U.S. site. Subjects have received the drug and post-administration monitoring is complete, with data analysis now underway.
Earlier this month, we initiated an absorption, metabolism and excretion (“AME”) study involving a total of 90 healthy volunteers being randomized to lower doses of otenaproxesul. The drug will be administered to each dose cohort for four weeks, followed by two weeks of post-drug monitoring. In addition to providing valuable information for potential partners, this study will further de-risk dose selection for the Phase III program, while also supplying pharmacokinetic data required for drug marketing approval. Following the anticipated completion of this study in the upcoming quarter, we will request a meeting with the FDA; that meeting will be the last key milestone before Phase III initiation.
Recent Validation Driving Partnering Activity
As we focus our partnering efforts on the large markets of the U.S., U.K., the four largest E.U. countries and Japan, we are benefiting from the validation inherent in our licensing deal earlier this year with Nuance Pharma in China. Supported by the unification of our IP ownership and the hiring of a premier pharma transaction firm to manage a formal outreach process, we are now interacting with pharmaceutical companies around the globe, with several conversations having reached the confidential stage. Recognizing that we are on the cusp of solving a problem that has challenged medical practice for 50 years, our strong corporate position provides us with the opportunity to select partners that can fully exploit otenaproxesul’s potential.
IP Development Creating New Value
In parallel with our Phase III preparations, we are working to realize the potential of our hydrogen sulfide platform through a cost-effective, early-stage research and development program. As recently announced, we have entered into a strategic collaboration with Dalriada Drug Discovery to aid us in identifying new drug candidates and to fortify the IP position of our current pipeline. Dalriada is presently screening molecules to select our go-forward candidate for inflammatory bowel disease (“IBD”), a process expected to be completed within months. With inflammation increasingly understood to underlie a wide range of health conditions, we look forward to broadening our pipeline to address this pervasive medical issue. We are also pursuing the development of fresh IP to lengthen the duration of patent and market protection available to our peri-operative pain and aspirin-based drug candidates.
Potential Listing on Senior U.S. Exchange Synchronized with Phase III Initiation
Our preparations for a potential listing on a senior U.S. exchange are largely complete. To capture the momentum of our upcoming Phase III program initiation, we are synchronizing a potential U.S. uplisting with our first Phase III trial. We also recognize that the completion of a strategic transaction for Citagenix would simplify Antibe’s story for new investors, and we are actively engaged in pursuing such an arrangement.
With a state-of-the-art Phase III design, enhanced bench strength and the support of a team of world-class service providers, we are poised to embark on the final phase of development of a best-in-class solution for millions of osteoarthritis patients and their doctors. Enabled by a strong balance sheet and heightened industry visibility, we also are well-positioned to partner with companies that can capture otenaproxesul’s potential. Our efforts to target inflammation more broadly are underway, addressing unmet medical needs across a spectrum of indications.
We look forward to updating you on our progress.
Chief Executive Officer
About Antibe Therapeutics Inc.
Antibe is leveraging its proprietary hydrogen sulfide platform to develop next-generation safer therapies to address inflammation arising from a wide range of medical conditions. The Company’s current pipeline includes three assets that seek to overcome the gastrointestinal (“GI”) ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs (“NSAIDs”). Antibe’s lead drug, otenaproxesul, is entering Phase III for the treatment of osteoarthritis pain. Additional assets under development include a safer alternative to opioids for peri-operative pain, and a GI-sparing alternative to low-dose aspirin. The Company’s next target is inflammatory bowel disease (“IBD”), a condition long in need of safer, more effective therapies. Learn more at antibethera.com.
Forward Looking Information
This news release includes certain forward-looking statements, which may include, but are not limited to, the proposed licensing and development of drugs and medical devices, and the potential of a US listing. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions "will", "anticipate", "believe", "plan", "estimate", "expect", "intend", "propose" and similar wording. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the Company’s inability to secure additional financing and licensing arrangements on reasonable terms, or at all, its inability to execute its business strategy and successfully compete in the market, and risks associated with drug and medical device development generally. Antibe Therapeutics assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.