Ampio Pharmaceuticals Profile
Ampio Pharmaceuticals, Inc. (Ampio) operates as a pre-revenue stage biopharmaceutical company.
Until May 2022 the company was focused on the clinical development of Ampion and preclinical development of AR-300, a novel, proprietary, small molecule formulation that has (i) demonstrated anti-inflammatory properties in vitro and (ii) protection of cartilage in preclinical rat meniscal tear studies.
Subsequently, the company have shifted nearly all of the company's focus towards the preclinical development of AR-300 and the company is conducting studies to evaluate the efficacy of AR-300 in osteoarthritis-related pain. If the preclinical data is compelling, the company would plan to initially target clinical development of AR-300 for the treatment of osteoarthritis of the knee (OAK). Osteoarthritis is widely regarded as being typified by cartilage loss. Substances that protect articular cartilage during the course of osteoarthritis have been termed chondroprotective. Clinical demonstration of cartilage protection and pain management in the knee could position AR-300 for administration early in the OAK treatment paradigm, which is a potentially large and attractive market opportunity.
The development of AR-300 as of December 31, 2022 has been based, in part, on the company's extensive drug discovery and clinical development experience obtained during the development of Ampion for the treatment of OAK. It is important to note, however, that AR-300 is not Ampion, rather it is a novel and unique formulation in preclinical development. The company expects to have preclinical pain and chondroprotection results for AR-300 in the first half of 2023.
In addition, and given the overall risks associated with preclinical drug development, the company continues to opportunistically identify and evaluate strategic opportunities that would allow the company to acquire or license later stage assets and/or merge with companies that have those assets as part of the strategic alternatives process that the company announced in May 2022. In 2022, the company evaluated more than a dozen potential strategic alternatives with the assistance of the company's legal, clinical and regulatory, and financial advisors consistent with the company's strategic alternatives process.
Intellectual Property
The following describes the company's patents and patent applications relating to AR-300 and Ampion.
AR-300
The company owns a number of the United States provisional patent applications covering AR-300, as well as its uses, formulations, and manufacturing processes. The company expects that these provisional patent applications, which are the patent rights the company consider most significant in relation to the company's business as a whole, will be consolidated and filed as a single PCT (Patent Cooperation Treaty) application in the second quarter of 2023. One or more national phase applications will be filed from this PCT application approximately eighteen (18) months later, in the third quarter of 2024.
Because the company is focused on the preclinical development of AR-300, the company anticipates filing additional patent applications in the future, covering new discoveries, formulations and/or research advancements in or relating to AR-300, as the company determines appropriate.
Patents covering AR-300 may extend for varying periods according to the date of patent filing or grant and the legal term of patents in the various countries where patent protection is obtained. Generally speaking, patents to issue from the above-mentioned PCT application will exist for a period of twenty years from the filing date of the PCT application, or until the second quarter of 2043. The scope of protection afforded by a patent can also vary from country to country and depends on the patent type, the scope of its patent claims and the availability of legal remedies. Patent term extensions (PTE) may be available in some countries to compensate for a loss of patent term due to delay in a product's approval due to the regulatory requirements.
Reliable patent protection and enforcement around the world are among the key factors the company considers for continued business and R&D investment. The WTO Agreement on Trade Related Aspects of Intellectual Property Rights (WTO-TRIPS) requires participant countries to provide patent and other intellectual property-related protection for pharmaceutical products by law, with an exemption provided for least developed countries until 2033.
Ampion
Globally, the company owns a large number of issued patents and pending patent applications covering Ampion, the company's proprietary biological pharmaceutical product, as well as its uses, formulations, and manufacturing processes. Given the decision to focus available resources on the research and development of AR-300, the company made the decision starting in 2023 to significantly limit or discontinue much of the existing patent portfolio covering Ampion. Those members of the existing Ampion patent estate that the company expects to continue to maintain will be based on the relative importance of technologies covered by patents, the geographic jurisdiction of patents, and remaining patent term.
