Relief Therapeutics Holding AG (RLFTF)

[Joe Kaplan]

Relief Therapeutics Announces Positive 12-Month Stability Data for Inhaled and Intravenous Preparations of RLF-100

Relief Therapeutics Holding SA / Key word(s): Research Update

17-Apr-2023 / 07:00 CET/CEST


GENEVA (April 17, 2023) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief Therapeutics, or Relief), a biopharmaceutical company committed to delivering innovative treatment options with the potential for transformative outcomes to benefit those suffering from select specialty and rare diseases, today announced positive 12-month stability data for the liquid and lyophilized preparations of RLF-100®, intended for intravenous (IV) and inhaled administration. RLF-100® is the company’s proprietary, investigational formulation of aviptadil acetate.

The data from the stability study showed that both inhaled and IV RLF-100® demonstrated high purity levels at 12 months at all temperatures tested, including refrigerated and room temperature environments. The results are consistent with prior data observed at three- and six-month intervals. The stability testing study will continue to determine the maximum shelf life of RLF-100®.

Based on the latest results, Relief Therapeutics intends to amend its previously filed provisional patent application for RLF-100® with the new findings. If granted, this patent could provide exclusivity for RLF-100® at least until 2042, without considering Hatch-Waxman extensions or other patent term adjustments. The Hatch-Waxman Act permits a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process.

“The testing conducted to date has consistently shown that our novel, optimized composition of aviptadil acetate provides better stability results in both the liquid and lyophilized preparations. RLF-100® was shown to be shelf stable and active after one year at temperatures suitable for shipping and long-term storage. This is an important milestone toward commercialization to ensure that RLF-100® is safe and effective, no matter where in the world it is supplied.” said Jack Weinstein, chief executive officer at Relief Therapeutics. “We believe this new, stable formulation has significant clinical and commercial value and our goal is to establish RLF-100® as the standard of care for the prevention and treatment of respiratory failure and its complications in both the acute and chronic applications.”

Stability testing of pharmaceutical products is mandatory for regulatory approvals. If a product fails to meet the standards prescribed by regulatory authorities, the product will not be granted approval for commercialization. Planning, execution and completion of studies in given timelines plays a major role in securing approval and ensuring a product reaches patients who need it.

RLF-100® is under development for the potential treatment of acute and chronic lung diseases, including pulmonary sarcoidosis, infectious acute respiratory distress syndrome (ARDS), checkpoint inhibitor-induced pneumonitis (CIP) and chronic berylliosis. The U.S. Food and Drug Administration (FDA) granted RLF-100® Orphan Drug designation (ODD) to inhaled RLF-100® for the potential treatment of pulmonary sarcoidosis in August 2021.


https://www.relieftherapeutics.com/newsblog-detail/?newsID=2490653