NORCROSS, Ga., April 02, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins today provided an update on the impact of the COVID-19 pandemic on the Company and its clinical trial activities.
As the global COVID-19 pandemic continues to quickly evolve, we have put measures in place intended to safeguard the health of our employees in line with many other companies. In doing so, we aim to do our part to help slow the spread of COVID-19 in our communities and protect our employees and their families, all while continuing the critical work necessary to initiate and conduct our NASH-RX clinical trial for patients with NASH cirrhosis.
In accordance with guidance issued by the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO) and local authorities, our employees are working remotely from home. We are now leveraging digital communication technologies to continue important interactions with healthcare professionals, patients and other stakeholders. We remain committed to completing and filing the NASH-RX protocol with the US Food and Drug Administration (FDA) in the near term. To date, we have suffered no significant financial hardships, delays or loss of any employees or contractors related to COVID-19.
The COVID-19 pandemic has substantially impacted the global healthcare delivery system including the conduct of clinical trials. As appropriate, many healthcare systems and providers have understandably prioritized caring for those suffering from COVID-19 and redirected resources in support of the broader community currently. This burden on the healthcare system has also impaired the ability of many clinical research centers to start new studies, enroll new patients and/or continue ongoing clinical trials. Most importantly, we must consider the risk to the patients of asking them to leave their homes and travel in an environment governmental authorities have deemed unsafe. At this time and as previously communicated, we plan to initiate the NASH-RX trial during the second quarter of 2020; however, this may be impacted by the COVID-19 pandemic.
Galectin Therapeutics Inc. has developed several overarching principles to guide its conduct of clinical research in light of COVID-19. Number one among these is the safety of patients, site personnel and our own employees. In addition, several health authorities have provided guidance for the conduct of clinical trials during this pandemic and suggestions related to assuring study integrity and the value of the data. Following this guidance, we can report the following actions and developments:
Galectin Therapeutics and the team at Covance, our CRO, are focused on those activities that we can directly control. For example, these include the completion of protocol and associated documents for new clinical trials and filing of protocols and associated documents with regulatory agencies, both in the US and internationally. This also includes numerous activities in conjunction with Covance and external vendors to ensure all internal systems such as study databases, adjudication systems, laboratory systems, data monitoring committee charters and the like are fully ready when trial sites are willing to restart their clinical research activities.
Clinical supply distribution and related activities with our external vendors are so far only minimally impacted. However, this could change in the coming weeks and months. Fortunately, we currently have an adequate supply of belapectin. External activities directed toward specific site start-up activities such as pre-study visits (using virtual techniques) by Covance employees, site contracting activities, training activities and site-directed ethic committee submissions will continue moving forward in conjunction with the site principal investigators and site coordinators, as well as with managers of the NASH site-specific network we are using.
We remain strongly committed to initiating our adaptive Phase 3 trial as soon as reasonably possible considering COVID-19. We are doing everything we can to minimize disruption and delays in site-related activities and patient enrollment and striving to do so in a safe and considerate manner. Further information will be forthcoming as we all navigate this situation.
Our hearts and thoughts go out to everyone whose lives have been seriously affected by COVID-19, and to our medical professionals on the front lines who are combating the virus.
About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’s lead drug belapectin (formerly known as GR-MD-02) is a carbohydrate-based drug that inhibits the galectin-3 protein which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the U.S. Food and Drug Administration. The lead development program is in non-alcoholic steatohepatitis (NASH) with cirrhosis, the most advanced form of NASH-related fibrosis. This is the most common liver disease and one of the largest drug development opportunities available today. Additional development programs are in treatment of combination immunotherapy for advanced melanoma and other malignancies. Advancement of these additional clinical programs is largely dependent on finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at www.galectintherapeutics.com.
