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Relief Therapeutics Holding SA / Key word(s): Miscellaneous
Relief Provides a Corporate Update and Comments on the Recently Announced Data Safety Monitoring Board (DSMB) Update on the U.S. National Institutes of Health (NIH) Study of Intravenous Aviptadil in Critical COVID-19 Patients
Geneva, Switzerland, May 31, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet needs, today provided a corporate update.
In the meantime, Relief intends to continue to advance the clinical assessment of RLF-100 in the following areas, consistent with its previously stated corporate objectives:
a. Continuation of the European clinical study of inhaled RLF-100 in COVID-19-infected patients (the Leuppi study), which is at an advanced stage of recruitment and slated to report top-line data later this year (subject to enrolment of eligible patients);
Aviptadil remains a molecule with a well-established mechanism of action and widely documented clinical evidence of biological activity, as well as a favorable human safety and tolerability profile established across two decades of clinical evaluation. As such, Relief believes that the drug merits continued assessment across an array of pulmonary conditions, regardless of whether the drug is ever approved for the treatment of COVID-19.
2) Relief intends to continue pursuing cost-effective, capital-efficient drug development with risk-mitigated assets. These currently include the following agents in Relief's pipeline beyond aviptadil:
a. GOLIKE, an optimized, prolonged-release, taste-masked amino acid mix for management of phenylketonuria (PKU) patients;
3) Relief has the following near- and medium-term catalysts:
a. Potential regulatory approval of ACER-001 by the FDA for the treatment of UCD (PDUFA date: June 5, 2022);
4) Relief is focused on establishing its U.S. commercial operations and initiating market rollout of its lead commercial product, PKU GOLIKE®, for the treatment of phenylketonuria ("PKU"). PKU GOLIKE® is a novel, proprietary next-generation prolonged-release amino acid mix for use as a mainstay of PKU therapy and is available in multiple formulations. Relief, through its wholly owned subsidiary, APR Applied Pharma Research SA ("APR"), currently markets this product in Europe with its direct sales and marketing infrastructure covering Germany, Italy, Austria and Switzerland and through exclusive third-party distributors in the remaining countries. The initiative to market this product in the U.S. will be led by Relief's Head of U.S. Commercial Operations, Anthony M. Kim, who has a lengthy track record of successful commercialization of drugs aimed at rare and specialty disease indications in the U.S. market. Relief has also hired Christopher Wick as National Sales Director in the U.S. Mr. Wick is leading the buildout of Relief’s U.S. field sales force and has a longstanding track record of performance in driving rare disease sales. Relief expects its highly targeted, specialized U.S. field sales force to be fully hired within the next several weeks.
5) Relief is working closely with its collaboration partner Acer Therapeutics on the preparation for a potential launch of ACER-001 in treatment of UCDs, assuming FDA approval of the product for commercialization. As a reminder, Acer is responsible for the U.S. commercialization of the drug and Relief is entitled to 60% of the profits from sales of the product in the U.S., pursuant to the collaboration agreement between the two companies. In addition, Relief and Acer continue to explore strategic options to advance the optimization of ACER-001's commercial value in the U.K. and Europe, as well as in territories beyond the U.S., U.K. and Europe. This includes the drug’s applicability in both UCDs and MSUD, along with other potential applications.
6) Relief currently has approximately CHF 31 million in cash and equivalents on its balance sheet, which, based on internal forecasts, Relief expects to be sufficient to fund operations well into 2023. Although there can be no assurance, Relief remains committed to achieving positive operating cash flow status by late 2024. In that regard, Relief's internal forecasts do not include any contribution from sales of aviptadil.
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer’s new drug application for ACER-001 for use as a treatment of urea cycle disorders was recently accepted by the FDA for filing with a PDUFA decision date of June 5, 2022. Relief also continues to study aviptadil for several possible lung related conditions. Finally, Relief's 2021 acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought to Relief a diverse pipeline of marketed and development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.
File: Ad hoc release
End of ad hoc announcement
|Company:||Relief Therapeutics Holding SA|
|Avenue de Secheron 15|
|Phone:||+41 22 545 11 16|
|Listed:||SIX Swiss Exchange|
|EQS News ID:||1364537|
|End of Announcement||EQS News Service|
8 July 2022