Abivax [EPA: ABVX]
Leveraging Technological Advancements for Developing Innovative Therapeutics
Marc de Garidel
In an interview with Life Sciences Review Europe, Marc de Garidel, CEO and interim chairman at Abivax, sheds light on implementing emerging technologies to increase access to lifesaving medications at potentially lower costs.
What are the primary challenges in the life sciences sector? How is innovation in technology addressing these challenges effectively?
The life science industry presents tremendous opportunities to address major health concerns that have previously remained unaddressed. It is evident that technological advancements are shaping the field with a notable trend toward precision medicine. This approach entails developing drugs or biomarkers that specifically target the underlying condition of the disease, offering targeted treatment and potentially minimizing side effects for patients.
Recently, there has been a proliferation of various technologies and modalities designed to tackle specific types of diseases, from traditional small molecules and biologics to protein therapies, monoclonal antibodies, and gene therapy. These diverse approaches have already shown promising results across different disease areas. However, amid these advancements, one pressing challenge is the escalating competition as more companies seek similar patient populations while performing clinical trials.
Another major challenge is related to funding. The industry has become substantially more challenging compared to just a couple of years ago in securing capital due to rising interest rates, geopolitical uncertainties, and long-term prospects. While companies with promising drugs and clinical data may still attract finances by raising substantial capital, this has led to industry consolidation and the closure of some companies that are unable to secure adequate funding.
Simultaneously, market access also poses a significant hurdle. For instance, while the US remains a market that embraces innovation, it has become more challenging due to payer-imposed hurdles aimed at cost control. The situation in Europe is more severe, with countries facing deficits and tough choices regarding public policy priorities and financing.
What strategic measures are you implementing to proactively mitigate potential challenges associated with biosimilars?
Our primary focus lies in the development of highly differentiated drugs that offer distinct advantages over existing competition and provide cost-saving benefits for payers as compared to traditional treatments.
At Abivax, our current phase 3 program for ulcerative colitis is simplifying drug administration with once-daily oral dosing. However, the most remarkable aspect of our drug, obefazimod, is the outcome observed in our recent phase 2b study. After two years of treatment, we found that approximately half of the patients achieved clinical remission, which is unique and remarkable among all the drugs that have been commercialized until now.
While we are encouraged by our drug's profile, it is important to note that we still need to conduct the phase 3 trials. The road to registering and launching the drug lies ahead of us. Nonetheless, phase 2b programs have generated significant excitement. During my attendance at the Digestive Disease Week (DDW) Congress, the largest digestive disease conference in the United States held in Chicago about two months ago, key opinion leaders even expressed considerable enthusiasm about the potential impact of this drug on patients with ulcerative colitis.
What is your advice for peers in the industry who are endeavoring to bring their products to market or initiate clinical trials?
The specific technological advancements and target population greatly influence the direction of development, be it for acute or current treatments, as there are notable distinctions. A key challenge that extends beyond the technical aspects of leading and conducting phase 3 studies is raising sufficient capital to ensure effective execution and fulfillment of our commitments. Readers should realize that approximately $200 million is required to conduct our pivotal phase 3 program. Therefore, it is imperative to secure additional funding not only to successfully conclude these phase 3 trials but also to prepare for the subsequent commercialization phase, which will demand further investment in clinical and medical aspects.
Our primary focus lies in the development of highly differentiated drugs that offer distinct advantages over existing competition and provide cost-saving benefits for payers as compared to traditional treatments.
However, from a broader perspective, I advise attracting US investors as they are renowned for their sophistication and financial resources. To achieve this, it is crucial to possess a comprehensive understanding of the US market and assemble a team that comprises individuals with profound knowledge in this domain. In my opinion, having a promising drug is not enough, one should have an adept management team to execute strategies effectively, that will help in establishing a reputable presence within the US market.
Could you give some insights regarding the future trajectory of the industry and the evolution of conventional methods of performing clinical trials?
The future role of AI in the execution of clinical trials holds significant potential for expediting patient access and enhancing accuracy. Additionally, it is important to note the impact of the recent US regulation known as the Inflation Reduction Act (IRA). This regulation may pose challenges regarding drug price negotiation, particularly in relation to small-molecule drugs, and biologics, which have a negotiation period of nine years and thirteen years respectively. Such challenges could be an impediment to innovation and development.
