EQS-News Relief Reports 2020 Financial Results and Provides Business Update
EQS Group-News: RELIEF THERAPEUTICS Holdings AG / Key word(s): Annual Results
Relief Reports 2020 Financial Results and Provides Business Update
Geneva, Switzerland, April 15, 2021 - RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company"), a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat COVID-19 induced lung injury, today announced its 2020 financial results for the year ended December 31, 2020 and provided a business update.
"The past year has been an incredibly productive and rewarding one for all of us at Relief," said Raghuram (Ram) Selvaraju, Chairman of the Board. "We have had an opportunity to make a true difference in fighting the ongoing COVID-19 pandemic with the development of RLF-100(TM) to treat critically ill patients. With the goal of bringing this potential treatment to patients as expeditiously as possible, we entered into important partnerships and made key hires, adding executives to our team who have strong expertise in important areas such as clinical development, regulatory and commercialization."
He continued: "Critical for the future growth of our Company, we also have taken a very important first step to broaden our development pipeline. We entered into a collaboration and license agreement for ACER-001, a compound in late-stage development for orphan diseases where patients are in need of better treatment options. We plan to continue to advance the development of our current programs and further grow our pipeline in the year ahead. I am excited about Relief's future as we work to provide patients with therapeutic relief in serious diseases with high unmet medical need."
Recent Key Development and Corporate Highlights:
Clinical Development Highlights (RLF-100)
- In March 2020, a U.S. phase 2b/3 trial of RLF-100(IV) for the treatment of patients with critical COVID-19 with respiratory failure commenced.
- In June 2020, RLF-100 (IV) was awarded Fast Track designation by the U.S. FDA for the treatment of acute lung injury (ALI) /acute respiratory distress syndrome (ARDS) associated with COVID-19.
- In July 2020, the FDA granted Expanded Access Protocol (EAP) designation for the treatment of respiratory failure induced by COVID-19 with RLF-100 (IV). Treatment was made available to patients who had exhausted standard therapies and were not eligible for the phase 2b/3 trial due to confounding medical conditions. Data from the first 21 patients in the EAP showed promising results demonstrating that some critically ill patients with COVID-19 experienced substantial clinical improvement when treated with RLF-100.
- In January 2021, Relief, its partner NeuroRx, and the Quantum Leap Healthcare Collaborative (QLHC) of San Francisco announced that NeuroRx and QLHC had signed a Clinical Trial Participation Agreement for the inclusion of inhaled RLF-100 in the I-SPY COVID-19 Clinical Trial. Quantum Leap is the sponsor of the I-SPY COVID-19 Trial, a platform trial that is assessing multiple drugs for the treatment of patients with critical COVID-19 who are hospitalized or in intensive care units.
- In January 2021, Relief and AdVita Lifescience GmbH signed a binding term sheet for Relief to acquire all shares of AdVita. Relief will gain access to all AdVita assets including future pending IP rights that may cover RLF-100 inhaled formulation specifications for the potential application of inhaled aviptadil in the treatment of lung diseases such as ARDS and Pulmonary Sarcoidosis.
- In February 2021, Relief's partner NeuroRx announced the initiation of a U.S. phase 2b/3 trial evaluating inhaled RLF-100 in patients with moderate to severe COVID-19 in order to prevent progression to respiratory failure.
- In March 2021, Relief's partner NeuroRx reported topline results (28-day and 60-day) from the U.S. phase 2b/3 trial evaluating RLF-100 (IV) for the treatment of patients with critical COVID-19 with respiratory failure. On the basis of the findings, NeuroRx plans to apply to the U.S. FDA for Emergency Use Authorization (EUA) and subsequently plans to submit a New Drug Application (NDA).
- In March 2021, NeuroRx announced that RLF-100 had been selected for inclusion in TESICO (Therapeutics for Severely Ill Inpatients with COVID-19), a phase 3 multicenter clinical trial that will include the United States and multiple foreign countries, that is being sponsored by the U.S. National Institutes of Health (NIH).