Deep dive into SynAct Pharma’s new strategy
With support from leading rheumatologists, SynAct Pharma is presenting a reshaped strategic plan for resomelagon in rheumatoid arthritis. In addition, they are planning to initiate a phase II trial with resomelagon in influenza patients and prepare the melanocortin agonist TXP-11 for clinical development. BioStock reached out to CEO Torbjørn Bjerke to learn more about the new strategic plan.
SynAct Pharma is at the forefront of resolving inflammation through selective melanocortin system activation. Their leading drug candidate, resomelagon (AP1189), targets rheumatoid arthritis (RA) and other autoimmune and inflammatory diseases. Additionally, SynAct Pharma has a big portfolio of melanocortin peptide agonists after the acquisition of TXP Pharma in January 2023.
2024 strategic plan
On February 2, SynAct Pharma announced a new strategic plan with focus on development in areas with high unmet medical need and high partnering interest. The strategy was formulated after review of pre-clinical and clinical data for resomelagon and with advice from leading experts. SynAct Pharma will hold a Capital Markets Day later in Q1 to provide further details on the strategic plan.
Primary DMARD-IR patients
The new strategy is divided into three pillars. To begin with, SynAct Pharma will initiate a 3-month phase II study with resomelagon in RA patients experiencing inadequate response (IR) to their initial course of methotrexate (MTX), which is a disease-modifying antirheumatic drugs (DMARD) and the most common first-line treatment for RA. This patient population, called primary MTX-IR patients or DMARD-IR patients, not only presents a significant unmet medical need but also attracts substantial partnering interest.
Listening to potential partner’s interest
A recent interview with the company highlighted the interest from big pharma towards this patient segment. In Synact’s prior studies, BEGIN and EXPAND, the focus was on treatment-naïve and newly diagnosed patients. However, the company suggests that there is little commercial value and no partner interest in this patient segment compared to DMARD-IR patients.
SynAct Pharma aims to initiate the DMARD-IR trial in the US and Europe during the second half of 2024. An important inclusion criterion for the study is elevated CRP, an inflammation biomarker that proved to be important for the patients’ response to resomelagon in the EXPAND phase IIb study.
Clinical trial in influenza patients
According to the new 2024 strategy, SynAct Pharma is also planning to initiate a proof-of-concept phase II trial with resomelagon in patients experiencing respiratory insufficiency due to influenza. This decision follows the positive phase IIa results from 2021 with resomelagon in Covid-19 infected patients experiencing pulmonary insufficiency.
The company will also continue to explore resomelagon’s mechanism of action and potential as a resolution therapy. Given the new strategic focus, SynAct has decided to withdraw the ongoing idiopathic membranous nephropathy (iMN) trial due to low enrollment.
Advancing TXP candidates
SynAct Pharma will also prepare for the first clinical trial with TXP-11 that is being developed for acute use in the critical care setting. The company is planning to initiate a phase I study with an intravenous form of TXP-11 in healthy volunteers in the first half of 2025.
SynAct will also advance other peptides with sustained release or other formulation or delivery technologies that could be used to treat various conditions including orphan diseases and inflammatory diseases. By the end of 2024, SynAct Pharma will be ready to initiate pharmacology studies and evaluate sustained release prototypes. The company will also explore potential collaborations to further advance the TXP peptides.
Bolsters team in accordance with the new strategy
To strengthen the team for the upcoming development activities, the company has recruited Kirsten Harting as new CMO, bringing more than three decades of experience within big pharma and biotech.
SynAct Pharma has also expanded its Rheumatology Clinical Advisory Board with three esteemed rheumatologists – Roy Fleischmann, Ravi Rao and Vibeke Strand. Each brings a wealth of experience and expertise in rheumatology that will be instrumental for the new strategic plan.
Comments from the CEO
BioStock reached out to SynAct Pharma’s CEO Torbjørn Bjerke to learn more about the strategy for 2024.
What insights from the BEGIN and EXPAND and interactions with potential partners have navigated you in this direction in RA?
– From BEGIN and EXPAND we have seen good activity especially in patients who presented with elevated CRP and we are very encouraged by the 3-month EXPAND data. We also see that resomelagon continues to be generally safe and well tolerated. From partners we have consistently heard that they desire to see data in commercially relevant populations, and they do not view first-line as relevant. Given our limited resources and the issues encountered with the execution of recent trials we decided that the most prudent thing to do was to be laser focused on getting partners the resomelagon data they requested.
»We decided that the most prudent thing to do was to be laser focused on getting partners the resomelagon data they requested.«
Soon, you will unveil results from the third-party audit of the RESOLVE study, which also targeted the DMARD-IR patient segment. What will be the main differences with the new phase II study compared to RESOLVE?
– We have not yet been able to release the results of the RESOLVE audit so we cannot go into exact details here, but one thing that was clear from our recent trials is that we need to better optimize trial design. Moving forward we will focus on patients with elevated CRP in all studies. We plan to focus on primary DMARD-IR patients who are experiencing an incomplete response to their initial treatment with methotrexate. This is one therapeutic step away from the treatment naïve patients in BEGIN and EXPAND. KOL feedback has supported study in this primary IR population, and this is a population that partners find very commercially relevant.
You are also planning to initiate a study with resomelagon in influenza patients and prepare for clinic with TXP-11. Why are these the best next steps for the company?
– The new study in influenza patients experiencing respiratory insufficiency builds of the strong COVID data we saw under the RESOVIR collaboration and provides a means of diversification away from RA in a category of roughly the same size. With preparation for TXP-11, we are excited to advance the peptides acquired in the TXP acquisition. Given our almost exclusive focus on resomelagon we feel it is important to advance the peptides to bolster our pipeline.
How does the recent appointments of CMO and members in the Rheumatology Clinical Advisory Board contribute to your new strategic plan?
– Every successful company needs to be a learning organisation, especially for companies of our size and structure. Two key learnings from our recent studies were the need to build in-house seasoned clinical development experience and to work with outside KOL advisors on clinical strategy and trial design. Kirsten Harting brings a broad wealth of clinical development experience to the team as our new CMO and will be instrumental in designing, executing, and managing our trials and development programs going forward.
»Every successful company needs to be a learning organisation, especially for companies of our size and structure. Two key learnings from our recent studies were the need to build in-house seasoned clinical development experience and to work with outside KOL advisors on clinical strategy and trial design.«
– The rheumatology KOL panel that we are building has already been instrumental in assessing resomelagon data and helping us fashion our strategy. The KOLs we are working with have been involved in every major advancement in RA and rheumatology and bring a wealth of clinical and study experience along with a knowledge of the overall workings of the sector and are well regarded by our prospective partners. We will implement these learnings as well as others to give resomelagon every chance to demonstrate its full potential.
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.
