Surrozen Publishes Study in 'Respiratory Research' Demonstrating the Promise of a Wnt Mimetic Antibody in Treating Pulmonary Fibrosis
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Insights
From the perspective of medical research, the data published by Surrozen is significant due to the unmet medical need in treating idiopathic pulmonary fibrosis (IPF), a condition for which current therapies are largely palliative rather than curative. The Wnt/β-catenin signaling pathway is known to be intricately involved in cell differentiation, proliferation and tissue repair. The ability of Surrozen's Wnt mimetic antibody to modulate this pathway could represent a novel therapeutic approach, potentially altering the treatment landscape for IPF.
It is important to note that IPF is characterized by progressive scarring of lung tissue, leading to irreversible loss of the organ's function over time. The preclinical success of a compound that not only reduces inflammation and fibrosis but also improves lung function is promising. However, the transition from preclinical models to human efficacy is fraught with challenges. The safety profile, dosage optimization and long-term effects of such a treatment in humans remain to be established through rigorous clinical trials.
Moreover, if the therapy proves to be successful, it could reduce the economic burden associated with IPF, which includes frequent hospitalizations, lung transplants and a high mortality rate. The potential market for an effective IPF treatment is substantial, given the current lack of curative options. This could translate into significant commercial success for Surrozen, impacting their stock valuation positively.
In evaluating the impact of Surrozen's announcement on the biotech market, it is essential to consider the competitive landscape of IPF treatments. Currently, the IPF market is dominated by antifibrotic agents that slow disease progression but do not reverse damage. Surrozen's Wnt mimetic approach, aiming at tissue repair and regeneration, could disrupt this market if clinical trials confirm the preclinical findings.
Investors should be aware that biotech firms like Surrozen often experience significant stock volatility around the release of clinical data due to the high risk-reward nature of drug development. Positive data can lead to increased investor confidence and a surge in stock prices, while negative data can have the opposite effect. The announcement of such promising preclinical results could lead to speculative investment, although caution is advised until further clinical data is available.
Furthermore, the biotech sector is highly sensitive to regulatory news. Progression into clinical trials and eventual FDA approval are major catalysts for stock movement. Surrozen's future clinical trial design, recruitment speed and results will be closely watched by the market. Analysts will also be monitoring partnership or acquisition interest from larger pharmaceutical companies looking to expand their respiratory disease portfolios.
The development of Wnt mimetic therapies for diseases like IPF is an example of targeted therapeutic strategies that have emerged in pharmaceutical development. Such targeted approaches can lead to more effective and potentially safer treatments by specifically modulating disease-relevant pathways. The Wnt pathway's role in tissue homeostasis and repair makes it an attractive target for regenerative medicine.
However, the specificity of Wnt signaling modulation is critical. Overactivation could lead to adverse effects, such as aberrant cell proliferation or differentiation. The design of Surrozen's antibody to selectively mimic Wnt signaling is, therefore, a key aspect of its potential success. It is also noteworthy that the systemic administration of the therapy was effective in the preclinical model, which suggests that the drug has the ability to reach the affected lung tissue in sufficient quantities.
From a drug development standpoint, the move from preclinical to clinical stages will involve a significant investment in time and resources. The scalability of manufacturing, stability of the molecule and delivery mechanisms are all factors that will need to be optimized to ensure that the therapy, if successful, can be widely available to patients.
In a preclinical model of pulmonary fibrosis, a Surrozen antibody-based SWAP platform molecule decreased pulmonary inflammation and fibrosis and improved lung function
Surrozen Wnt mimetic SWAP molecules also expanded alveolar organoid cultures and impacted multiple lung cell types in vivo
Results highlight the potential of Wnt mimetic agonists to repair tissue after damage in severe lung diseases like idiopathic pulmonary fibrosis
SOUTH SAN FRANCISCO, Calif., April 03, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively modulate the Wnt pathway for tissue repair and regeneration, announced today publication of data in Respiratory Research highlighting the potential for Surrozen’s Wnt mimetic technologies to treat serious lung diseases like idiopathic pulmonary fibrosis (IPF) https://respiratory-research.biomedcentral.com/articles/10.1186/s12931-024-02786-2. The results observed with systemic administration of Surrozen’s Wnt mimetic antibody in an acute bleomycin model of pulmonary fibrosis demonstrate a Wnt pathway mediated decrease in inflammation and fibrosis and improvement in lung function.
Idiopathic pulmonary fibrosis (IPF) is an interstitial lung disease characterized by areas of myofibroblast accumulation and extracellular matrix (ECM) deposition, disruption of alveolar architecture, and restricted lung physiology. In pulmonary fibrosis, multiple cell types may need to be targeted to provide a regenerative environment facilitating repair. Mechanisms that stimulate expansion of certain beneficial cell types in the lung which also limiting expansion of fibrosis promoting cell types and of pro-inflammatory cells may be desirable.
The canonical Wnt/β-catenin signaling pathway plays an important role in the lung alveolar epithelium. During development this pathway is critical for the establishment of alveoli. In adult lungs, a subset of alveolar type 2 (AT2) cells are stem cells, and Wnt/β-catenin signaling is required for AT2 cell maintenance and renewal under both normal and injured conditions. Furthermore, activation of Wnt signaling has been found to have an anti-inflammatory effect on macrophages in several mouse lung damage models.
“Current treatments for severe lung diseases like IPF aren’t able to regenerate normal, functional tissue,” said Yang Li, Ph.D., Executive Vice President, Research at Surrozen. “This work published in Respiratory Research represents a breakthrough in understanding the role of the Wnt pathway in lung fibrosis and the potential for Wnt mimetics to reduce fibrosis and improve lung function.”
About SZN-043 for Severe Alcohol-Associated Hepatitis
SZN-043 is the first development candidate using Surrozen’s SWEETS™ technology. Surrozen is developing SZN-043 for severe liver diseases, initially focusing on alcohol-associated hepatitis. The Company has completed a Phase 1a clinical trial in patients with chronic liver disease and healthy volunteers. SZN-043 demonstrated acceptable safety and tolerability in all subjects, with evidence of target engagement, Wnt signal activation and effects on liver function. The Company is initiating the Phase 1b clinical trial in patients with severe alcohol-associated hepatitis and expects that proof-of-concept data from this trial may be available in the first half of 2025.
About SZN-413 for Retinal Diseases
SZN-413 is a bi-specific antibody targeting Fzd4-mediated Wnt signaling designed using Surrozen’s SWAP™ technology. It is currently being developed for the treatment of retinal vascular-associated diseases. Data generated by Surrozen with SZN-413 in preclinical models of retinopathy demonstrated that SZN-413 could potently stimulate Wnt signaling in the eye, induce normal retinal vessel regrowth, suppress pathological vessel growth and reduce vascular leakage. This novel approach could thus potentially allow for regeneration of healthy eye tissue, not only halting retinopathy, but possibly allowing for a full reversal of the patient’s disease.
In the fourth quarter of 2022, Surrozen entered into a strategic partnership with Boehringer Ingelheim for the research and development of SZN-413 for the treatment of retinal diseases. Under the terms of the agreement, Boehringer Ingelheim received an exclusive, worldwide license to develop SZN-413 and other Fzd4-specific Wnt-modulating molecules for all purposes, including as a treatment for retinal diseases, in exchange for an upfront payment to Surrozen of
About Wnt Signaling
Wnt signaling plays key roles in the control of development, homeostasis, and regeneration of many essential organs and tissues, including liver, intestine, lung, kidney, retina, central nervous system, cochlea, bone, and others. Modulation of Wnt signaling pathways has potential for treatment of degenerative diseases and tissue injuries. Surrozen’s platform and proprietary technologies have the potential to overcome the limitations in pursuing the Wnt pathway as a therapeutic strategy.
About Surrozen
Surrozen is a clinical stage biotechnology company discovering and developing drug candidates to selectively modulate the Wnt pathway. Surrozen is developing tissue-specific antibodies designed to engage the body’s existing biological repair mechanisms with a current focus on severe liver and eye diseases. For more information, please visit www.surrozen.com.
Forward Looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws. Forward-looking statements generally are accompanied by words such as “will,” “plan,” “intend,” “potential,” “expect,” “could,” or the negative of these words and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding Surrozen’s discovery, research and development activities, in particular its development plans for its product candidates SZN-043 and SZN-413 (including anticipated clinical development plans and timelines, and the availability of data, the potential for such product candidates to be used to treat human disease, as well as the potential benefits of such product candidates), and the Company’s partnership with Boehringer Ingelheim, including the potential for future success-based development, regulatory, and commercial milestone payments, in addition to mid-single digit to low-double digit royalties on sales. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management of Surrozen and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Surrozen. These forward-looking statements are subject to a number of risks and uncertainties, including the initiation, cost, timing, progress and results of research and development activities, preclinical or and clinical trials with respect to SZN-043, SZN-413 and potential future drug candidates; the Company’s ability to fund its preclinical and clinical trials and development efforts, whether with existing funds or through additional fundraising; Surrozen’s ability to identify, develop and commercialize drug candidates; Surrozen’s ability to successfully complete preclinical and clinical studies for SZN-043, SZN-413, or other future product candidates; the effects that arise from volatility in global economic, political, regulatory and market conditions; and all other factors discussed in Surrozen’s Annual Report on Form 10-K for the year ended December 31, 2022 and Surrozen’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 under the heading “Risk Factors,” and other documents Surrozen has filed, or will file, with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Surrozen presently does not know, or that Surrozen currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Surrozen’s expectations, plans, or forecasts of future events and views as of the date of this press release. Surrozen anticipates that subsequent events and developments will cause its assessments to change. However, while Surrozen may elect to update these forward-looking statements at some point in the future, Surrozen specifically disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Surrozen’s assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.
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