Relief Will Acquire Rights to Potential Sarcoidosis Therapy RLF-100 in Deal

As part of a new agreement with AdVita Lifescience, Relief Therapeutics will acquire the intellectual rights for the specifications and potential applications of an inhaled formulation of RLF-100 (aviptadil).

Relief has been collaborating with NeuroRx to advance the development of RLF-100 to treat patients with severe COVID-19 respiratory complications and other lung disorders, including pulmonary sarcoidosis.

RLF-100 is an artificial form of a peptide hormone, called vasoactive intestinal peptide (VIP), that is naturally produced throughout the body and has been found to have potent anti-viral and anti-inflammatory properties.

By acquiring the rights to AdVita’s therapy formulation, Relief also will accelerate and secure RLF-100’s future development as an inhaled therapy for lung diseases, such as pulmonary sarcoidosis, that are associated with COVID-19. Other lung diseases associated with COVID-19, which also could potentially be treated by RLF-100, include checkpoint inhibitor-induced pneumonitis, and acute respiratory distress syndrome (ARDS).

Of note, the other current formulation of RLF-100 is as an intravenous (into-the-vein) infusion.

Relief is getting the intellectual rights to RLF-100 as part of a binding term agreement in which it will acquire all shares of AdVita, along with several company assets.

“AdVita’s intellectual property around inhaled formulations of Aviptadil and its team’s expertise with Aviptadil will be invaluable as we move forward with the development of the inhaled formulation of RLF-100 for the treatment of COVID-19-related ARDS, as well as other potential lung disease indications, such as pulmonary Sarcoidosis,” Jack Weinstein, chief financial officer and treasurer of Relief, said in a press release.

“We look forward to initiating the development of inhaled RLF-100 in Europe within the coming months for COVID-19 patients using inhaled Aviptadil. Furthermore, we plan to re-start a clinical development program for RLF-100 in pulmonary Sarcoidosis later this year,” Weinstein said.

A Phase 3 clinical trial involving 200 sarcoidosis patients was originally planned for 2019 but was postponed in favor of the development of RLF-100 for COVID-19, according to Relief’s website.

Previous results from a Phase 2 trial called Avisarco II, which involved 20 patients with pulmonary sarcoidosis, showed that RLF-100 could significantly suppress inflammatory processes in the lungs, Relief says on the “Pipeline” page of its website. The therapy, which showed a good safety profile, also was found to ease the symptoms — namely dry cough, and shortness of breath during exertion — of patients with sarcoidosis.

“We are excited to combine our specific expertise in inhaled formulations of Aviptadil with Relief’s comprehensive scientific catalog of the compound and its uses in respiratory diseases,” said Dorian Bevec, PhD, chief scientific officer of AdVit.

In exchange for AdVita’s shares, Relief will provide the German pharmaceutical company with €25 million ($30 million) of its common shares, along with up to €20 million ($24 million) in future milestone payments. This transaction is expected to be completed by the second quarter of this year.

Under the terms of the binding agreement, Relief also will provide AdVita with a secured loan. Part of the payment will be completed along with the closing of the binding agreement; payment of the remaining part is tied to the completion of Relief’s Phase 2/3 trial (NCT04311697) of intravenous RLF-100 in patients with critical COVID-19 and respiratory failure.

Top-line data from this study is expected in the coming weeks.