Paracrine Announces Publication of STAR Trial Including Improved Hand Function and Quality of Life in Patients With Diffuse Cutaneous Scleroderma

FDA-approved STAR II trial designed and powered based on these results

SAN DIEGO, April 04, 2022–(BUSINESS WIRE)–Paracrine, Inc., today announced the online publication (ahead of print) of STAR I trial results in Arthritis and rheumatology Newspaper, the official journal of the American College of Rheumatology. The manuscript of Khanna et al. is titled “Transplantation of adipose-derived regenerative cells in systemic sclerosis: treatment of scleroderma with celution-treated adiposity-derived regenerative cells – a randomized clinical trial” ( /epdf/10.1002/art.42133).

The STAR I trial was a randomized, placebo-controlled trial that assessed improvement in hand function in patients with diffuse cutaneous sclerosis (dcSSc) or limited cutaneous sclerosis (lcSSc) with hand dysfunction who had been treated with autologous adiposity-derived cell regenerative (ADRC) therapy. The primary endpoint of this study was change in hand function at 24 and 48 weeks, assessed using a validated patient-reported outcome measure, the Hand Function Scale of Cochin (CHFS).

Additional endpoints included changes in the Health Assessment Questionnaire Disability Index (HAQ-DI) and the General Health-Related Quality of Life Rating (EQ-5D). The study design included analyzes of predefined subgroups of patients with dcSSc or lcSSc.

“The initial STAR I trial, designed and conducted by our predecessor, was an important feasibility study that provided valuable actionable insights into optimal patient selection and endpoints,” noted Dr. Alex Milstein, Director Clinic and Executive Vice President of Clinical Affairs for Paracrine. “I would like to express our gratitude to the patients, researchers and clinical trial staff who made this trial possible.”

Although the STAR I trial did not meet its primary endpoint, it produced a number of important results that helped guide the design and selection of the STAR II trial endpoints – an appropriately powered, FDA-approved, pivotal Phase III trial in patients with dcSSc:

  • Efficacy trends demonstrating improvement in CHFS were observed in dcSSc patients at 24 weeks (p=0.111) and 48 weeks (p=0.069)

  • ADRC-treated patients with dcSSc reported improvement in Health Assessment Questionnaire Disability Index (HAQ-DI) at 48 weeks (p=0.044)

  • The majority of patients with dcSSc (52%) reported improvement greater than the minimum clinically important difference for CHFS and HAQ-DI compared to 16% in the placebo group (nominal p=0.016, post-hoc analysis )

  • The majority of patients with dcSSc (63%) showed improvement in HAQ-DI at 48 weeks greater than the established minimum clinically important difference, compared to only 26% in the placebo group (nominal p-value=0.019, post- hoc Analysis)

  • ADRC-treated patients with dcSSc reported improvement in Health-Related Quality of Life (EQ-5D 3L) survey at 48 weeks (p=0.005)

  • Beneficial effects in dcSSc patients were maintained for 48 weeks

  • The procedure and injections were well tolerated and there were no new safety issues

“The consistency and durability of clinically significant improvement in patients with diffuse cutaneous sclerosis in this trial supports our hypothesis that a single treatment with ADRCs is safe and feasible, improves patients’ ability to perform daily activities and improves their quality of life,” commented Dr. Dinesh Khanna, professor of rheumatology at the University of Michigan and co-principal investigator of the STAR I and STAR II trials.

“Despite the importance of hand dysfunction in patients with systemic sclerosis, there are few treatments that have been shown to be effective that specifically address this problem,” Dr. Khanna continued. “Based on these very consistent and promising results in patients with diffuse scleroderma cutis, we plan to initiate the STAR II trial by this summer to conclusively determine these benefits for this medically untreated condition.”

In January 2022, the FDA granted an Investigational Device Exemption (IDE) approval for Paracrine to conduct a pivotal trial in patients with diffuse cutaneous scleroderma titled Treatment of scleroderma with Celution® Processed Adipose-Derived Regenerative Cells: A Randomized, Double-Blind, Placebo-Controlled Study—the “STAR II trial”. The primary endpoint will be change in the Cochin Hand Function Scale at 26 weeks.

About Paracrine

Paracrine, Inc. is an emerging biotechnology company developing the world’s first device-based pleiotropic cell therapy platform to treat chronic debilitating diseases. Paracrine’s cell therapy platform holds the promise of cost-effectively treating the common underlying pathology of chronic debilitating diseases due to its multimodal mechanisms of action. The company is advancing several late-stage IDE clinical trials in the United States based on strong prior data.

About Celution® System

Celution® The system is a proprietary medical device designed to process human adipose tissue to extract, isolate, and concentrate a mixture of adiposity-derived regenerative cells (ADRCs) for subsequent reimplantation into the same patient.

About the STAR I trial

The STAR trial was a prospective, randomized, double-blind, placebo-controlled, multicenter trial to evaluate the safety and efficacy of Celution® ADRC treated system administered by subcutaneous injection for the treatment of impaired hand function due to systemic scleroderma.

The trial recruited 88 patients, 40 randomized to the placebo arm and 48 to the ADRC arm. The trial predefined subsets of patients with limited and diffuse scleroderma, with the diffuse scleroderma subset comprising 51 patients, of whom 32 were enrolled in the ADRC treatment group and 19 in the control group. The majority of subjects (85%) were female, the mean age was 53 years and the mean disease duration was 13 years.

About the STAR II trial

STAR II is a Phase III Pivot Test designed to provide a robust data set on the safety and efficacy of adipose-derived regenerative cells (ADRC) in the treatment of patients with hand dysfunction due to diffuse cutaneous scleroderma.

The trial is designed as a prospective, randomized (1:1), placebo-controlled, double-blind, multicenter study. The primary endpoint is change in the Cochin Hand Function Scale (CHFS) at 26 weeks. The CHFS is a validated patient-reported outcome for the assessment of hand function in patients with scleroderma.

About the Cochin Hand Function Scale (CHFS)

The Cochin Hand Function Scale (CHFS) is a validated patient-reported score for the assessment of hand function in systemic sclerosis. The instrument assesses five domains rated from 0 (no problem performing the task) to 5 (unable to perform) with a total score ranging from 0 to 90. The survey consists of 18 questions which indicate the ability to perform the activities of everyday life, including in the kitchen, dressing room, bathroom, office, and miscellaneous. A lower score indicates a greater ability to perform the task. Patients with Diffuse Cutaneous Scleroderma with a CHFS > 20 are eligible for the STAR II trial.

About scleroderma

Scleroderma is a rare, chronic connective tissue disease generally classified as an autoimmune rheumatic disorder. The word “scleroderma” is derived from two Greek words: “sclera”, which means hard, and “derma”, which means skin, because the hardening of the skin is one of the most visible manifestations of the disease.

Diffuse cutaneous scleroderma (also known as systemic scleroderma) is a debilitating, chronic disease primarily affecting women and resulting in significant disability, including hand dysfunction.

An estimated 200,000 Americans have scleroderma, of which about 80,000 have the systemic form of the disease, known as systemic sclerosis (SSc). SSc is further subclassified as diffuse cutaneous or limited cutaneous SSc. An estimated 30,000 patients have diffuse cutaneous SSc, the most severe disease with significant hand dysfunction.

Systemic sclerosis contributes to hand impairment through inflammatory arthritis or joint inflammation, joint contractures, Raynaud’s phenomenon (RP, discoloration of the skin resulting from narrowing of blood vessels in response to cold, stress), digital ulcers, swollen hands, skin fibrosis in the fingers and hands, and calcinosis (calcium deposits in the soft tissues of the hand). These manifestations contribute to the difficulty of professional activities and daily life, impacting the quality of life. There is currently no effective treatment available for hand deficiency.

Note: Celution® The system and ADRCs are not currently approved in the United States

Caution Regarding Forward-Looking Statements

This press release contains forward-looking statements regarding events, trends and business prospects that may affect our future results of operations and financial condition. Such statements, including, but not limited to, those regarding our ability to initiate and execute the STAR II pivotal trial, are forward-looking statements. These statements are subject to risks and uncertainties that could cause our actual results and financial condition to differ materially. Some of these risks include clinical and regulatory uncertainties, inherent difficulties in convincing physicians and patients to adopt new technology, dependence on the performance of third parties, the performance and acceptance of our products, as well as than other risks and uncertainties. Paracrine assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.

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