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2022-12-05| PartnerSpecial

RemeGen Presented New Data Updates on Telitacicept for SLE and primary Sjogren’s syndrome at ACR Convergence 2022

by GeneOnline
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PHILADELPHIA – RemeGen attended the American College of Rheumatology’s (ACR) annual meeting, ACR Convergence 2022, from Nov 10-14, to present promising phase III trial data for SLE which met its primary endpoint, and phase II trial data for primary Sjogren’s syndrome which showed encouraging safety and efficacy data.

Telitacicept is a human recombinant fusion protein targeting B-Lymphocyte Stimulator (BLyS) and A Proliferation Inducing Ligand (APRIL) in Systemic Lupus Erythematous (SLE), and other B-cell mediated autoimmune diseases.

Dan Ross, senior vice president of global business development at RemeGen, discussed some of RemeGen’s history and philosophy, including their objectives for attending this key rheumatology event, which was to connect with the rheumatology community, provide exciting new data on telitacicept, and to cross-pollinate ideas with fellow attendees on how to collectively advance new promising treatment options to patients. Below are some of the topics discussed during a 1-1 interview with Mr. Ross at ACR 2022.

How did RemeGen get started and what is its philosophy?

RemeGen Ltd. was founded in 2008 by Dr. Jianmin Fang, CEO and CSO, and, Mr. Weidong Wang, Chairman, who had the vision of launching RemeGen into a space where few Chinese biotech companies have gone before, which is to be innovative and drive real solutions for unmet medical needs. For the first decade of RemeGen’s history, the company was well resourced to support their R&D activities which kept them out of the limelight. In 2017,  the company emerged showcasing an impressive pipeline with very promising drugs targeting oncology, autoimmune diseases and ophthalmology. Telitacicept, or RC18, is being developed to treat several B-cell mediated autoimmune diseases and is the main reason RemeGen attended ACR this year.

What do you hope to achieve by attending the ACR 2022 event?

We’re embarking on an ambitious global phase II/III SLE study. The first 90 patients will be enrolled in the phase II, which is ongoing. The 91st patient randomized will trigger the start of the phase III.

“Here at ACR, we’re trying to help the rest of the rheumatology community know about what RemeGen is doing [and] about our product, telitacicept, and invite them to be our investigator sites and enroll their patients in our phase III study. Recruiting patient in this space has been very slow and difficult.”

“We have tremendous urgency to move telitacicept along its development cycle, through regulatory approvals, and get it to patients globally. Since it was conditionally approved in China in 2019, more than 10,000 patients have been treated with telitacicept as of the end of October. Data from completed studies is supportive of its efficacy in patients, as shared at this meeting, with [an] acceptable safety profile. We continue to aggressively push the global phase III study forward and iron out any kinks as we move along. That’s where we need all the help of the community.”

Tell me about RemeGen’s experience running a global phase III study?

“This is the first global phase III study that RemeGen is embarking on. While there’s always a “first”, we’ve been learning about ways to successfully conduct this phase III study through networking, just as we are doing here at ACR, and not just with all the great rheumatologists around here, but to also include all the key opinion leaders, top company executives and practice administrators, asking for their advice.

I think we all have the same goal, and this goes back to one of the tenets of the founding principles of RemeGen, and that is “Science with a Purpose”. So while RemeGen’s mission is to continue to push the envelope on addressing the unmet medical needs, everyone at ACR wants the same, too. That’s why it’s so great to be here at this conference as we’re building that nexus of energy and hoping that collectively, we can turn that into momentum to evolve the treatment options for patients.”

What are some of the challenges faced on the journey of bringing telitacicept to more patients in need?

“I think one of the biggest challenges is attributable to the confounding effects of background steroid therapy, leading to an observed “high placebo response” in the phase III trial. As the background steroid therapy, which is permitted in the trial provided it has reached a stable dose, could mask the disease manifestations, therefore it could lead to an inaccurate conclusion on response in the placebo group. The challenge here lies in working closely with investigators to explore ways to minimize steroid use for patients who are stable, in order to better characterize the treatment effects of telitacicept; based on accruing data, telitacicept could potentially and meaningfully lower the disease burden of patients, while lowering patients’ exposure to systemic steroids which bring upon many negative long-term side effects.  

Could you tell us more about RemeGen’s pipeline?

“I would like to expand on telitacicept because telitacicept has a dual mechanism of action, binding to and neutralizes the activity of two cell-signaling molecules, a proliferation-inducing ligand (APRIL) and B-lymphocyte stimulator (BLyS). This pathway is not limited to the pathogenesis of lupus but also other diseases, such as IgA nephropathy, myasthenia gravis, Sjogren’s syndrome, and lupus nephritis, which is the renal progression of lupus, that RemeGen is actively developing telitacicept to tackle those diseases as well. Beyond these activities, there are several other molecules in early-phase development.”

 What is the expected global launch timeline for Telitacicept?

“Globally, we are targeting a 2026 launch, and that is contingent upon us keeping to our timelines and hitting our milestones. There are certainly multiple risks that we’re mitigating, but I do want to be realistic because there are always hurdles in the way. What’s really great is that in 2019, based on exceptional phase IIb data alone, the Chinese regulators granted RemeGen conditional approval. The condition was to run a phase III study.

Since then, we have launched the product in China and have been treating patients, and the most encouraging part is that we’re seeing patients getting better. We’re seeing the momentum of uptick in telitacicept use in the market. Our salesforce has been telling us that patients are going to their doctors and asking to be put on telitacicept. That’s really exciting to see in this market in China, but we want to be doing more for patients, globally. And so, there’s still this uphill battle of getting through the regulatory process, and everything in-between.”

What about any highlights here at ACR that you are seeing?

“I think everybody is glad to be back in person as virtual meetings the last two years were just not the same. We presented a Late Breaking Abstract at the last in-person meeting, which was 2019, and at the time, it really made a lot of waves, and people were excited.

Fast forwarding to this conference, I’ve seen a lot of advancements in the areas that I’m focused on with SLE, and several other B-cell mediated autoimmune diseases.”

“Within the disease area of lupus, I think the evolution from all the lessons learned from so many prior trials, and most of which haven’t come to successful conclusions, continue to build our knowledge base to try to solve the problems that these debilitating diseases present.”

For more on telitacicept, please visit here

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