Phase 1 Study in Mild COVID-19 Patients Demonstrated a Favorable Safety and Tolerability Profile and Statistically Significant Clinical Symptom and Biomarker Improvements
Additional Analysis Demonstrates Caspase Inhibition Proactively Modulates the Immune Response to COVID-19
SAN DIEGO, Nov. 02, 2021 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO), a clinical-stage company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function and its partner, Amerimmune, LLC, today announced that Amerimmune’s CEO, Oral Alpan, MD, will present updated findings from the emricasan Phase 1 study in mild symptomatic COVID-19 patients at the American College of Allergy, Asthma, and Immunology Conference in New Orleans on November 6, 2021. The presentation details are as follows:
EVENT: American College of Allergy, Asthma, and Immunology
DATE: November 6, 2021
TITLE: Role of Cellular Caspases and Therapeutic Potential of a Pan-Caspase Inhibitor, Emricasan, in COVID-19
“The Phase 1 trial showed excellent safety in early-stage, mildly symptomatic COVID-19 patients in a small cohort of individuals that received orally-dosed emricasan. Emricasan shortened clinical symptoms and quickened recovery from COVID-19 when compared to placebo group. In addition, the original discovery made by Amerimmune on disease-related biomarkers, including elevated caspase levels, enabled us to focus on understanding how the virus affects the immune system, as opposed to how the body reacts to the coronavirus infection. Most of the current approaches to treating COVID-19 focus on how the body is reacting after the infection. Our approach, with emricasan, is to target the infection with a proactive treatment that prevents an overactive immune system that leads to uncontrolled inflammation and severe symptoms,” said Oral Alpan, MD, CEO of Amerimmune LLC.
“We are pleased that the positive findings from our emricasan clinical program targeting mild symptomatic COVID-19 patients have been accepted for an oral presentation at this prestigious medical conference and we look forward to supporting our partner Amerimmune as they seek to advance emricasan in the clinic through one or more partnerships,” said Richard W. Pascoe, CEO of Histogen.
About Emricasan
Emricasan is a potential first-in-class, orally active, pan-caspase inhibitor designed to reduce the activity of enzymes that mediate inflammation and apoptosis. Histogen acquired certain rights to emricasan and other caspase inhibitor compounds as a part of its merger with Conatus Pharmaceuticals Inc. in 2020. Histogen believes that by reducing the activity of these enzymes, caspase inhibitors have the potential to interrupt the progression of a variety of diseases. To date, emricasan has been studied in over 950 patients in 19 completed clinical trials across a broad range of liver diseases. In NASH cirrhosis patients in multiple clinical Phase II trials conducted by Conatus, emricasan demonstrated rapid and sustained reductions in elevated levels of key biomarkers of inflammation and cell death. Similarly, elevated biomarkers are also believed to play a role in the severity and progression of COVID-19. Amerimmune and Histogen reported positive top-line results from its Phase 1 clinical trial in mild COVID-19 patients in June of 2021.
About Histogen Inc.
Histogen Inc. is a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function. Histogen’s innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen’s proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications, including joint cartilage regeneration, spinal disk repair, tendon, ligament, and other soft tissue repair. For more information, please visit www.histogen.com.
About Amerimmune
Amerimmune LLC is a research center and immunology laboratory with a strong focus on identifying underlying mechanisms of immune disorders. Amerimmune’s mission is to bring relevant science, data, and diagnostic and therapeutic solutions to diseases that involve the immune system. Amerimmune LLC is a spinoff of Amerimmune Diagnostics LLC, which is focused on establishing a network of physician-owned immunology labs across the United States. Amerimmune Diagnostics’ clinical approach led to the development of the innovative therapeutics’ technology upon which Amerimmune was founded. When the COVID-19 pandemic emerged, Amerimmune brought its expertise to bear against this devastating disease. Amerimmune is a privately held development-stage company based in Fairfax, VA. For more information and to explore partnering opportunities, please visit www.amerimmune.com.
About the Histogen and Amerimmune Collaboration
Under the terms of the collaboration, Histogen retains ownership and oversight over the emricasan asset, responsibility for all regulatory filings and maintaining the existing emricasan patent portfolio. Amerimmune will fund the emricasan development efforts, maintain its own portfolio of patents for caspase inhibition and immunotherapy, and, in collaboration with Histogen, lead the development efforts. Additionally, Amerimmune has an option to commercialize emricasan under certain conditions for the sole purpose of supporting future third-party partnering transactions. Should any such partnering transaction emerge, Histogen and Amerimmune will share profits equally. Histogen and Amerimmune manage the collaboration under a joint development and partnering committee governance structure.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss our future operations and our ability to successfully initiate and complete clinical trials, obtain clinical trial data and achieve regulatory milestones and related timing, including those related to the timing of providing clinical development guidance on the emricasan clinical program for the potential treatment of COVID-19; the potential that future clinical trials will establish efficacy of our product candidates, including emricasan; the potential for emricasan to be a first-in-class product; the nature, strategy and focus of our business; the sufficiency of our cash resources and ability to achieve value for our stockholders; the sufficiency of Amerimmune’s cash resources and its ability to further develop emricasan and achieve value for our stockholders; and the development and commercial potential and potential benefits of any of our product candidates, including emricasan. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of ours that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of our product candidates, including potential delays in the commencement, enrollment and completion of clinical trials and Amerimmune’s ability to further develop emricasan for the potential treatment of COVID-19, including the complexity and length of studies required to commercialize emricasan for COVID-19 and potential delays in the completion of clinical trials; our dependence on our collaboration partner, Amerimmune, to carry out the development of emricasan and the potential for delays in the timing of regulatory approval; competition in the COVID-19 market and other markets in which we and our collaboration partner operate; the potential that earlier clinical trials and studies of our product candidates may not be predictive of future results, such as the week 14 data results from the emricasan Phase 1 study and these additional findings; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses; and the requirement for additional capital to continue to advance our product candidates, including emricasan, which may not be available on favorable terms or at all. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including those risks discussed in our filings with the Securities and Exchange Commission. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events, or circumstances or otherwise.
CONTACT:
Susan A. Knudson
Executive Vice President & CFO
Histogen Inc.
ir@histogen.com
