Relief Reports Regulatory Clearance in Germany to Commence a Multicenter, Double-blind, Randomized Phase 2 Clinical Trial to Evaluate Inhaled Aviptadil for the Treatment of Sarcoidosis

Rhea-AI Summary

Relief Therapeutics announced regulatory clearance for its subsidiary, AdVita Lifescience, to initiate a phase 2 clinical trial in Germany to evaluate inhaled aviptadil for treating sarcoidosis. This follows a proof-of-concept trial that showed potential benefits in 20 patients. The trial will be randomized, double-blind, and multicenter, focusing on alleviating sarcoidosis-related cough, which significantly impacts patient quality of life. This milestone supports Relief’s strategy of advancing treatment options for serious diseases with unmet needs.

Positive

• Regulatory clearance granted for phase 2 trial of inhaled aviptadil for sarcoidosis.
• Proof-of-concept trial showed potential benefits in suppressing inflammatory mechanisms.
• Trial aims to address significant symptoms like cough and dyspnea, enhancing patient quality of life.

Negative

• Success of the phase 2 trial remains uncertain and depends on clinical outcomes.
• Potential regulatory hurdles for aviptadil approval in the EU and U.S.

GENEVA, SWITZERLAND / ACCESSWIRE / September 2, 2021 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that its recently acquired German subsidiary, AdVita Lifescience GmbH ("AdVita"), has received regulatory clearance to commence a phase 2 clinical trial in Germany to evaluate inhaled aviptadil for the treatment of sarcoidosis.

Following a proof-of-concept trial in 20 sarcoidosis patients which demonstrated the suppression of inflammatory mechanisms of the lung in combination with amelioration of dry cough and exertional dyspnea, AdVita received clearance by the German medical regulatory authority Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) to conduct a randomized, double-blind, multicenter clinical trial in sarcoidosis patients.

Raghuram Selvaraju, Chairman of the Board of Relief, commented, "Receiving regulatory clearance to begin a phase 2 clinical trial of inhaled aviptadil marks another clinical milestone for Relief and our subsidiary, AdVita. Aviptadil is believed to be the only known experimental drug that could potentially suppress sarcoidosis-associated cough, one of the major symptoms reducing quality of life in this patient population. We look forward to initiating this trial and to further exploring the clinical utility of aviptadil across multiple pulmonary indications."

ABOUT SARCOIDOSIS

Sarcoidosis is a rare disease in which the inflammatory process involves the alveoli (air sacs), small bronchi, and small blood vessels. As sarcoidosis progresses, small lumps, or granulomas, appear in the affected tissues which tend to remain inflamed and become scarred (fibrotic). Granulomas are structured masses composed of activated immunological cells (macrophages, lymphocytes, mast cells and fibroblasts). Many Sarcoidosis patients are left with permanent lung damage as they undergo a chronic course where complications such as pulmonary fibrosis are common and irreversible. Sarcoidosis affects up to about 100,000 people in the European Union, and a similar or higher amount in the U.S.

ABOUT RELIEF

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's lead drug candidate, RLF-100^TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,

in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is 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. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, brings 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 symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

CONTACT:

RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com

FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the phase 2 trial evaluating inhaled aviptadil for the treatment of sarcoidosis will be successful, (ii) whether inhaled aviptadil will ever be approved by the EU and/or the U.S. for the treatment of sarcoidosis or for any other indications, or (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

SOURCE: Relief Therapeutics Holdings AG

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https://www.accesswire.com/662494/Relief-Reports-Regulatory-Clearance-in-Germany-to-Commence-a-Multicenter-Double-blind-Randomized-Phase-2-Clinical-Trial-to-Evaluate-Inhaled-Aviptadil-for-the-Treatment-of-Sarcoidosis

FAQ

What is the purpose of the phase 2 clinical trial for RLFTF?

The trial aims to evaluate the efficacy of inhaled aviptadil in treating sarcoidosis.

What were the results of the previous trial involving aviptadil for sarcoidosis?

The proof-of-concept trial demonstrated suppression of inflammation and improvement in symptoms.

What are the next steps after the regulatory clearance for RLFTF?

Relief Therapeutics will initiate the randomized, double-blind, multicenter phase 2 trial.

What impact could the trial results have on the market for RLFTF?

Positive trial results could lead to market approval for aviptadil, impacting share value.