TORONTO--(BUSINESS WIRE)--Antibe Therapeutics Inc. (TSXV: ATE, OTCQB: ATBPF):
To our stakeholders,
The recent success of our lead drug, ATB-346, in its Phase 2B gastrointestinal (“GI”) safety clinical study was a significant milestone for Antibe and represented a major inflection point in our value. Furthermore, we are now one clinical study away from the strategic monetization of our drug platform for the major markets. With such an important and exciting time ahead of us, we thought this would be an ideal opportunity to communicate our strategy for the next year and beyond.
Nearly ten years ago, Antibe was formed to develop safer medicines for pain and inflammation by leveraging our novel hydrogen sulfide (“H2S”) technology. Over this period, our strategy to maximize value for shareholders has remained consistent: advance our drug candidates to Phase 2 proof-of-concept data and secure high-value partnerships for the large pharmaceutical markets. Fast forward to 2018: we now have unequivocal validation of our H2S platform, and are well-positioned to conclude a series of transformational partnerships over the next 12-18 months.
This progress could not have been done without the support of our shareholders, who are now being rewarded for their patience over the years. In the months ahead, our team will be working diligently to ensure that our clinical and business development activities are well aligned with our strategy to maximize shareholder return.
Recent Phase 2B Study Confirms Best-in-Class Status for Drug Platform
In Antibe’s latest Phase 2B study, ATB-346 showed unequivocal superiority to naproxen in GI safety (2.5% versus 42.1% ulceration rate) in 244 healthy volunteers. This human proof-of-concept data replicated the results of our pre-clinical studies, and provides clear validation of the GI-protective properties of our H2S technology. The full analysis of this study will be reported this quarter. We are now pushing forward with the planned Phase 2 effectiveness study for ATB-346, and are accelerating development of our other H2S platform drugs. Each of Antibe’s drugs has blockbuster potential, and would provide physicians and consumers with radically safer alternatives to today’s NSAIDs and to the multi-dimensional dangers of corticosteroids and opiates.
Upcoming Phase 2 Effectiveness Study Designed to Validate Efficacy of ATB-346
With human GI safety for ATB-346 now firmly established, our next clinical objective is to validate its effectiveness at reducing pain in osteoarthritis (“OA”) patients. In August 2016, Antibe released top-line data from a Phase 2A study that showed considerable pain relief for ATB-346 at a once-daily dose of 250 mg - the pain relief observed was nearly double that of naproxen and Celebrex based on published data. Although these results were encouraging, the study was conducted in a small number of patients and was not controlled. Our upcoming Phase 2 effectiveness study is designed to validate the pain reduction efficacy of ATB-346 (versus control) and will be conducted in approximately 250 OA patients. In addition, we have biomarker data derived from Phase 1 and Phase 2 blood assays that suggest ATB-346 is effective at lower doses; for this reason, the study will include two additional dosing cohorts with the goal of determining the lowest effective dose. Preparations are well underway for this study and we anticipate commencing it by July with a data read-out in Q4 2018.
Additional Clinical Activities to Support Global Partnering Efforts
In addition to the Phase 2 effectiveness study, Antibe will also be strategically allocating R&D spend towards activities that we feel will be of the most value to global partners. These activities include: (i) long-range animal toxicology studies (6 months and 9 months) for ATB-346, a standard regulatory requirement for approval of any drug; (ii) additional metabolic studies for ATB-346 to further strengthen our understanding of its pharmacokinetic profile; and (iii) the completion of IND-enabling studies for both ATB-352 and ATB-340, Antibe’s two other H2S platform drugs. Although ATB-352 and ATB-340 are earlier stage, both individually represent blockbuster drug opportunities and have been considerably de-risked by the latest validation of our H2S technology. We remain particularly excited about the potential of ATB-352, a non-addictive, potent analgesic for acute pain that directly addresses the global opioid epidemic, a crisis that the world is struggling to contain.
Partnering Discussions Building Momentum
In the past, Antibe’s partnering efforts were focused on strategically out-licensing the rights for smaller markets (i.e., outside of the United States and Western Europe). We continue to have these discussions and have been successful in concluding two regional deals to-date – this activity remains valuable as it provides non-dilutive funding and further validation of our drug platform. The recent human proof-of-concept GI safety data have undoubtedly benefited these on-going discussions, and more importantly, now allow us to engage multinational pharmaceutical firms to secure strategic partnerships for the large markets. As mentioned earlier, our clinical development activities in the next 12 months are designed to maximize the value of our drug platform and strengthen our position as we engage potential partners.
Commercial Asset in Regenerative Medicine Well-Positioned For Growth
Our subsidiary, Citagenix Inc. (“Citagenix”), is nearly done assembling the building blocks for its growth strategy in the dental regenerative medicine market. Citagenix’s sales team in the United States is working hard at expanding its distribution network, and recently signed Benco Dental, the 3rd largest dental distributor in the US by market share. Antibe’s relationship with Citagenix has been a symbiotic one: Antibe provided the resources to position Citagenix on a growth trajectory while Citagenix provided valuable diversification. With Citagenix now on a path to growth and Antibe’s drug development activities de-risked considerably by the recent GI safety data, our team will now begin exploring strategic alternatives for Citagenix in an effort to unlock value for shareholders.
Strong Balance Sheet and Maturing Capital Markets Strategy
Antibe’s balance sheet is well-funded with approximately $5 million of cash, and recently benefited from the entire conversion of its debentures. The upcoming Phase 2 effectiveness trial for ATB-346 will be funded entirely with cash-on-hand. In addition, given our stage of development, we are now exploring a listing on the NASDAQ exchange to grow our institutional investor base in the United States.
We look forward to the year ahead as we drive closer towards our goal of bringing safer medicines to market for pain and inflammation.
Chief Executive Officer
About Antibe Therapeutics Inc.
Antibe develops safer medicines for pain and inflammation. Antibe’s technology involves linking a hydrogen sulfide-releasing molecule to an existing drug to produce a patented, improved medicine. Antibe’s lead drug ATB-346 targets the global need for a safer, non-addictive drug for chronic pain and inflammation. ATB-352, the second drug in Antibe’s pipeline, targets the urgent global need for a non-addictive analgesic for treating severe acute pain, while ATB-340 is a GI-safe derivative of aspirin. www.antibethera.com.
Antibe’s subsidiary, Citagenix Inc. (“Citagenix”), is a leader in the sales and marketing of tissue regenerative products servicing the orthopedic and dental marketplaces. Since its inception in 1997, Citagenix has become an important source of knowledge and experience for bone regeneration in the Canadian medical device industry. Citagenix is active in 15 countries, operating in Canada through its direct sales teams, and internationally via a network of distributor partnerships. www.citagenix.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. 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 expressions. 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 Inc. 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.