Histogen Announces Initiation of HST 003 Phase 1/2 Trial for Knee Cartilage Regeneration

Rhea-AI Summary

Histogen Inc. (NASDAQ: HSTO) has initiated a Phase 1/2 clinical trial for HST 003, a treatment aimed at regenerating hyaline cartilage in the knee through the application of human extracellular matrix (hECM) in conjunction with a microfracture procedure. Participating clinical sites include OasisMD, The Steadman Clinic, and Walter Reed Medical Center. This double-blind, placebo-controlled trial will assess safety and efficacy using MRI and outcome scores like KOOS and IKDC. HST 003 has shown promising results in preclinical studies, indicating potential for various orthopedic applications.

Positive

• Initiation of Phase 1/2 clinical trial for HST 003 represents a significant milestone.
• HST 003 has demonstrated ability to regenerate mature cartilage and improve joint function in preclinical models.

Negative

• Clinical trials may face delays and uncertainties impacting future results.
• Additional capital may be required to advance HST 003, which could be difficult to secure.

SAN DIEGO, June 30, 2021 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO), today announced the initiation of its Phase 1/2 clinical trial of HST 003 to evaluate the safety and efficacy of human extracellular matrix (hECM:HST 003) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. Clinical sites participating in the trial include: OasisMD in San Diego, CA, The Steadman Clinic in Vail, CO and Walter Reed Medical Center in Bethesda, MD.

“The initiation of the HST 003 clinical trial as a treatment for regeneration of knee cartilage marks a major milestone for Histogen as we focus on developing best in class orthopedic therapeutics with our novel regenerative medicine platform technology,” said Richard W. Pascoe, Histogen’s President and CEO.

About the HST 003 Trial
This double-blind placebo-controlled trial is designed to evaluate the safety and efficacy of hECM implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. Primary and secondary endpoints will include safety assessments, MRI to evaluate cartilage regeneration, and Knee Injury and Osteoarthritis Outcome Score (KOOS) and International Knee Documentation Committee (IKDC) scores to evaluate pain and joint function.

About HST 003
Histogen’s human extracellular matrix, or hECM, is intended for regenerating hyaline cartilage for the treatment of articular cartilage defects with a novel malleable scaffold that stimulates the body’s own stem cells. In multiple preclinical models, HST 003 has been shown to regenerate mature cartilage and well vascularized bone, indicating great therapeutic potential in the sports medicine, spinal disc repair, orthopedic, and dental areas. Studies conducted by outside experts have demonstrated that HST 003 is anti-inflammatory, angiogenic, and can stimulate the growth of stem cells in damaged areas to induce tissue regeneration. The most extensive in vivo work in animals has focused on the regeneration of new hyaline cartilage and bone in full thickness knee injuries.

About Histogen
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, dermal rejuvenation and hair growth. For more information, please visit www.histogen.com.

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 Histogen’s future operations and its ability to successfully initiate and complete clinical trials, obtain clinical trial data and achieve regulatory milestones and related timing, including those related to enrollment of the Phase 1/2 clinical trial of HST 003 for regeneration of cartilage in the knee; the nature, strategy and focus of Histogen’s business; and the development and commercial potential and potential benefits of any of Histogen’s product candidates, including HST 003. Histogen 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 Histogen’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Histogen 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 Histogen’s product candidates, including potential delays in the commencement, enrollment and completion of clinical trials, such as the enrollment of the Phase 1/2 clinical trial of HST 003 for regeneration of cartilage in the knee; the potential that earlier clinical trials and studies of Histogen’s product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm Histogen’s financial condition and increase its costs and expenses; and the requirement for additional capital to continue to advance these product candidates, 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 Histogen’s filings with the Securities and Exchange Commission. Except as otherwise required by law, Histogen disclaims 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

FAQ

What is the purpose of the HST 003 clinical trial?

The HST 003 clinical trial aims to evaluate the safety and efficacy of hECM for regenerating hyaline cartilage in the knee.

When was the HST 003 trial initiated?

The Phase 1/2 clinical trial for HST 003 was announced on June 30, 2021.

What are the expected outcomes of the HST 003 trial?

Expected outcomes include safety assessments and improvements in cartilage regeneration, pain relief, and joint function.

What are the risks associated with HST 003's clinical trial?

Risks include potential delays in enrollment and completion of trials, and the need for additional capital.

How might HST 003 impact the market?

If successful, HST 003 could become a first-in-class therapeutic option for knee cartilage regeneration, potentially impacting the orthopedic market significantly.