Stayble Therapeutics is in phase IIb with the drug candidate STA363 for the treatment of disc-related chronic low back pain. The next step is to initiate a phase III study with one or more partners, and then launch the product on the market. To learn more about the regulatory pathway to this goal, we spoke with Sara Richardson, VP CMC & Regulatory Affairs.
Stayble Therapeutics’ injectable drug candidate STA363 is intended for patients with disc-related chronic low back pain who do not get better with painkillers or physical therapy, and who are unable to undergo back surgery. STA363 consists of lactic acid that transforms the disc into connective tissue, which is believed to provide permanent pain relief.
A phase IIb study with STA363 is currently underway to evaluate the efficacy of the treatment. The company’s goal is to recruit all patients to the study in 2022 and report study results in 2023.
Meeting with FDA and probing partners for phase III
To launch a new drug on the market, the treatment must demonstrate safety and intended effect. This is being evaluated in clinical studies, where phase III is the last step before you can apply for approval for the treatment.
Stayble Therapeutics is now identifying potential partners for phase III and market launch. An important market for Stayble is the US, where the company is in close contact with Key Opinion Leaders and plans to have interactions with the FDA later in the year to identify an optimal regulatory pathway forward.
Interview with VP CMC & Regulatory Affairs
BioStock contacted Sara Richardson, VP CMC & Regulatory Affairs of Stayble Therapeutics since July 2021, to get to know more about the regulatory process.
You have been part of Stayble Therapeutics’ management team for about a year now. What have been your focus areas so far?
– During my first year at Stayble Therapeutics, I have focused on matters surrounding our product that need to be put in place for the upcoming phase III study such as final formulation, sustainability, analytical methods for control of product quality, manufacturing, and supply of the product, etc.
– Another important area has been the regulatory strategy going forward. During the past year, I have worked out a regulatory roadmap towards phase III and launch together with the Stayble team and external consultants. We have also initiated activities with high priority.
Could you describe the regulatory pathway to phase III and subsequent market approval and launch?
– As we will close patient recruitment in the phase IIb study in 2022, we have now begun to plan and prepare for the phase III study, regarding the design of the study (endpoints, size, length, etc.), where it will be performed, as well as control, manufacturing, and supply of the product. We will have interactions with regulatory authorities to discuss our phase III plans, first up is a meeting with the FDA in the second half of 2022.
»We will have interactions with regulatory authorities to discuss our phase III plans, first up is a meeting with the FDA in the second half of 2022.«
– We aim to submit a 505(b)(2) application in the US and a full-mixed application according to Article 8(3) in Europe, which in short means that our market application will to some extent be based on safety studies and data from the literature, as lactic acid is already a very well-studied and well-established substance in other clinical contexts. This means that we have a shorter path to market approval compared to if we had developed a completely new substance that would have required us to perform a much more extensive package of both in vitro and in vivo, and clinical safety studies. The proposed regulatory path to registration is also something we will discuss with and get confirmed by the regulatory authorities at the above-mentioned meetings.
You plan to have interactions with the FDA shortly – what is the aim with these?
– The goal of our planned pre-IND meeting with the FDA is to describe our drug candidate STA363 and our development plans going forward, to get the authority’s view, input on and acceptance of these. This means that we will discuss key strategic issues surrounding the product itself and its manufacturing and control, the clinical development plan and the regulatory path forward.
– This first interaction with the FDA is also important for initiating contact and creating a good relationship with the authority, which will be very valuable in our development work going forward with STA363.
If you succeed in presenting positive results from the phase IIb study at the end of 2023, when will you be able to initiate a phase III study?
– In the event of positive phase IIb results, the phase III study is planned to start in the second half of 2024.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.