TORONTO–(BUSINESS WIRE)–Antibe Therapeutics Inc. (TSXV: ATE, OTCQB: ATBPF):
To our shareholders,
As we approach the end of Phase 2 development for ATB-346 and launch into global partnering discussions, we thought this would be an ideal time to reflect on recent developments and reiterate our strategy to maximize value for shareholders.
Last year was pivotal for Antibe as we delivered dramatic gastrointestinal (“GI”) safety data for our lead drug, ATB-346, in a head-to-head Phase 2B study versus naproxen, the most prescribed NSAID in the United States. This was an important result as it strongly suggests we have solved one of the most pervasive medical problems of our time: the GI safety issue with NSAIDs. Our Phase 2A efficacy study and recent dose-ranging metabolism study in humans provided encouraging effectiveness and COX inhibition data. Collectively, this gave us the confidence to march forward with a Phase 2B efficacy study of impressive scale – a total of 360 patients across 35 clinical sites in what is considered one of the largest clinical studies ever undertaken in Canada. A successful data read-out in this trial will fully validate the best-in-class status of ATB-346 in a US$11 billion drug category, and will set the stage for global partnering activity.
Our overarching objective for shareholders remains the same: monetize our drug pipeline through high-value partnerships for the large pharmaceutical markets. Given the strength of our existing data package and the successful conclusion of Phase 2 within our reach, we feel we are well positioned to deliver upon that goal.
Phase 2B Dose-Ranging, Efficacy Study Remains on Track
Our Phase 2B dose-ranging, efficacy study for ATB-346 remains on track for a top-line data read-out this summer; the study is well underway with all 35 clinical sites actively enrolling patients. The study is designed to validate the effectiveness of ATB-346 in reducing osteoarthritis (“OA”) pain and establish the lowest effective dose. Specifically, the study includes three doses of ATB-346 that will be individually assessed for superiority versus placebo. With a total of 360 patients, the study powers both the high dose (250 mg) and middle dose (200 mg) for statistical significance which will provide more robust efficacy data that can be leveraged as we engage global partners. Importantly, this is the final Phase 2 study for ATB-346 and represents a major development milestone and inflection point for Antibe if one of the doses meets the primary endpoint.
Gearing Up for Successful End-of-Phase 2 Meeting with FDA
In parallel with our development activities for ATB-346, we have been busy readying the drug for a successful IND application and positive end-of-Phase-2 meeting with the FDA. This preparation is non-trivial and require comprehensive data packages encompassing pharmacokinetics, metabolism, toxicology, chemistry and manufacturing, among other factors. We have assembled a team of regulatory experts to support this initiative, including several former heads of FDA directorates and a leading regulatory agency based out of Washington, DC. Our efforts to fully elucidate the metabolic pathways of ATB-346 over the past year are nearly complete and will be very valuable in regulatory discussions. A successful end-of-Phase-2 meeting strengthens our position with future partners as it surmounts a major regulatory hurdle in the United States and we will pursue that as expeditiously as possible, once the Phase 2B results are in hand.
Partnering Discussions Await Key Phase 2B Efficacy Data
We have seen mounting interest in ATB-346 since the dramatic Phase 2B GI safety data last year. At the moment we are in discussions with numerous pharmaceutical companies across the globe, and our data room has never been more active. Due to risk management, the vast majority of pharmaceutical companies require complete Phase 2 human proof-of-concept data before licensing a drug – we are on the verge of surpassing this requirement. Furthermore, our partnering advisory team has been a superb resource and is adding invaluable depth to our business development efforts. Assuming the Phase 2B efficacy results are favourable, we anticipate being in a position of strength to execute a series of regional and global licensing deals.
Non-Opioid Acute Painkiller, ATB-352, Poised to Deliver Value in Partnership Deals
With the clinical advancement of our lead drug, ATB-346, we continue to validate our hydrogen sulfide (H2S) technology platform. We are now leveraging this platform to unlock further value for shareholders and potential partners. In support of this initiative, we recently announcing the lead indication for the next drug in our pipeline, ATB-352, a non-addictive, potent analgesic for treating acute pain. Post-operative pain is a US$9 billion market opportunity that is in desperate need of safer treatment alternatives without abuse potential. Furthermore, the recent characterization of our strategy for ATB-352 affirms to potential partners that Antibe is building a best-in-class platform of drug candidates that address several blockbuster markets.
Commercial Asset in Regenerative Medicine Delivering Impressive Growth
Citagenix Inc. (“Citagenix”), our commercial asset in regenerative medicine is now delivering impressive growth driven by the successful roll-out of its US expansion strategy. Sales in the United States were up 62% year-over-year in the fiscal 2019 period, and we’re seeing that growth rate accelerate in the current fiscal period. We expect its recent performance to benefit strategic discussions that are geared to unlock additional value for shareholders.
The time has never been more exciting for Antibe with another pivotal inflection point on the horizon. We look forward to the next 12 months as we complete our final Phase 2 clinical trial for ATB-346 and work on executing significant partnerships to maximize shareholder value.
Sincerely,
Dan Legault
Chief Executive Officer