180 Life Sciences Corp. Announces Collection of All Patient Data for Phase 2b Dupuytren’s Disease Trial

Rhea-AI Summary

180 Life Sciences Corp. (NASDAQ: ATNF) has successfully collected and submitted all patient data from its Phase 2b clinical trial for Dupuytren’s disease, conducted in partnership with the University of Oxford. The trial involved 181 patients and analyzed the efficacy of adalimumab, administered over a series of injections. Despite delays due to the COVID-19 pandemic, data analysis is underway, with results expected to be released in Q4 2021. This trial addresses a significant medical need, as no current approved therapies exist for early-stage Dupuytren’s disease, potentially impacting patient quality of life.

Positive

• Completion of patient data collection for Phase 2b Dupuytren’s disease trial.
• The trial addresses an unmet medical need with no current approved treatments.
• Partnership with reputable institutions like the University of Oxford and funding from Wellcome Trust.

Negative

• Data analysis has been delayed due to the COVID-19 pandemic.

MENLO PARK, Calif., April 20, 2021 (GLOBE NEWSWIRE) -- 180 Life Sciences Corp. (NASDAQ: ATNF) (180 Life Sciences or the "Company"), a clinical-stage biotechnology company focused on the development of novel drugs that fulfill unmet needs in inflammatory diseases, fibrosis and pain, today announced that all patient data for the Phase 2b Dupuytren’s disease clinical trial has been collected and submitted for analysis and review.

The trial is sponsored by the University of Oxford and funded by the Wellcome Trust and UK Department of Health with a contribution from 180 Life Sciences. In this double-blind placebo-controlled trial, 181 patients were randomized across 3 sites, two in the UK and one in the Netherlands. The nodule was injected on up to four occasions at three-month intervals with 40mg adalimumab in 0.4ml or an equivalent volume of placebo, and the patients followed for a further 6 months. Follow up was delayed by the COVID-19 pandemic. The data is currently being analyzed and is planned to be published in a peer-reviewed journal in an open access format. At that stage the Company will announce the top line data.

Dr. James Woody, 180 Life Sciences Chief Executive Officer commented, “Despite the challenges posed by the COVID-19 pandemic and shut down of clinical sites across Europe due to government restrictions, we are fortunate to have had our investigators with the help of additional support from the Wellcome Trust, complete the collection of data. The data is being reviewed and validated, which is not an easy task under current conditions. The analysis will be according to the previously agreed Statistical Analysis Plan. We remain on track to announce a top-line data read out from this trial in Q4 2021.”

Currently there is no approved therapeutic for preventing early stage Dupuytren’s disease and patients who develop finger contractures can struggle with many activities of daily living. Treatments for late-stage disease all have significant shortcomings.

About 180 Life Sciences Corp.

180 Life Sciences Corp. is a clinical-stage biotechnology company focused on the development of novel drugs that fulfill unmet needs in inflammatory diseases, fibrosis and pain by leveraging the combined expertise of luminaries in therapeutics from Oxford University, the Hebrew University and Stanford University. 180 Life Sciences is leading the research into solving one of the world’s biggest drivers of disease – inflammation. The Company is driving groundbreaking studies into clinical programs, which are seeking to develop novel drugs addressing separate areas of inflammation for which there are no effective therapies. The Company’s primary platform is a novel program to treat fibrosis using anti-TNF (tumor necrosis factor).

Forward-Looking Statements

This press release includes "forward-looking statements", including information about management’s view of the Company’s future expectations, plans and prospects, within the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 (the “Act”). Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results and, consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements and factors that may cause such differences include, without limitation, statements relating to expectations regarding the capitalization, resources, and funding of the Company; expectations with respect to future performance, growth and anticipated acquisitions; the continued listing of the Company on The NASDAQ Stock Market; the ability of the Company to execute its plans to develop and market new drug products and the timing and costs of these development programs; estimates of the size of the markets for its potential drug products; potential litigation involving the Company or the validity or enforceability of the intellectual property of the Company; global economic conditions; geopolitical events and regulatory changes; the expectations, development plans and anticipated timelines for the Company's drug candidates, pipeline and programs, including collaborations with third parties; access to additional financing, and the potential lack of such financing; and the Company’s ability to raise funding in the future and the terms of such funding. These risk factors and others are included from time to time in documents the Company files with the Securities and Exchange Commission, including, but not limited to, its Form 10-Ks, Form 10-Qs and Form 8-Ks, as well as in the definitive proxy statement/prospectus that the Company filed in connection with the recent merger. These reports and filings are available at www.sec.gov. All subsequent written and oral forward-looking statements concerning the Company or other matters and attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements above. Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made, including the forward-looking statements included in this press release, which are made only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, except as otherwise provided by law.

Investors:

Jason Assad
Director of IR
180 Life Sciences Corp
(678) 570-6791
Jassad@180lifesciences.com

Media Relations:

David Schull
David.Schull@russopartnersllc.com        
(212) 845-4271

FAQ

What are the key details of the Phase 2b Dupuytren's disease clinical trial by ATNF?

The Phase 2b trial involved 181 patients and focused on the efficacy of adalimumab, with data collection completed despite delays caused by the COVID-19 pandemic.

When will the results of the Dupuytren's disease trial be announced for ATNF?

The top-line data results from the trial are expected to be announced in Q4 2021.

What is the significance of the Dupuytren's disease trial for ATNF?

The trial seeks to address the lack of approved treatments for early-stage Dupuytren’s disease, which can impact patients' daily activities.

Who is sponsoring the Dupuytren's disease clinical trial for ATNF?

The trial is sponsored by the University of Oxford and funded by the Wellcome Trust and the UK Department of Health.