Relief Therapeutics

Relief Therapeutics is a Swiss biopharmaceutical company headquartered in Geneva and focused on therapies for serious diseases with high unmet medical need. The company was founded in 2013 by Gael Hédou and presents itself as the successor to the earlier biotechnology enterprise Mondobiotech, whose research portfolio included vasoactive intestinal peptide, or VIP. Mondobiotech had been founded in 2000 by Fabio Cavalli and Dorian Bevec and obtained United States and European patents in 2006 for a synthetic version of VIP known as aviptadil. The company's corporate history is linked to a restructuring of the Mondobiotech-related business. In June 2013, Mondobiotech merged with Pierrel Research International, an Italian pharmaceutical research company, to create the contract research organization Therametrics. In July 2016, Therametrics merged with Relief Therapeutics, creating Relief Therapeutics Holdings AG and transferring the aviptadil-related intellectual-property portfolio into the combined business. Relief also acquired FirstString Research in 2016, adding a clinical-stage biotechnology operation based in Charleston, South Carolina. Relief became particularly visible during the COVID-19 pandemic through its development of RLF-100, a synthetic form of aviptadil. Aviptadil is derived from VIP, a naturally occurring peptide associated with protective effects in the lungs. Relief and its collaborators investigated the product as a potential treatment for severe respiratory disease and acute respiratory distress related to COVID-19. In June 2020, the United States Food and Drug Administration granted RLF-100 fast-track designation for respiratory distress associated with COVID-19. Relief subsequently partnered with NeuroRx, later known as NRx Pharmaceuticals, to coordinate United States development and clinical trials. The product was also referred to as Zyesami in the pandemic-era development program. The COVID-19 program generated substantial clinical and regulatory attention but did not result in emergency authorization in the United States. In November 2021, the FDA declined an emergency-use request while indicating that it would continue working with the developers on further development. NRx later reported an analysis of data from an NIH-sponsored Phase 3 study that it said showed improved 60-day survival among patients receiving Zyesami compared with placebo. Relief and NRx also became involved in litigation over alleged breaches of their collaboration agreement, with Relief filing a lawsuit in New York in October 2021. Beyond aviptadil, Relief has expanded through acquisitions and partnerships. In January 2021, it acquired German company AdVita under an agreement valued at €25 million, with the stated objective of advancing inhaled treatments for acute respiratory distress syndrome. In May 2021, Relief acquired Applied Pharma Research, a Swiss biotechnology and pharmaceutical-development company, for CHF 72 million. APR brought commercial products and pipeline assets into the group, including work related to Sentinox, Nexodyn, and nutritional management for phenylketonuria. APR reported interim clinical data in October 2021 for Sentinox, a nasal spray intended to reduce viral load in people with COVID-19, while PKU GOLIKE KRUNCH was launched in Germany and Italy in September 2021. Relief has also pursued programs outside COVID-19. Its development activities have included RLF-100 research for non-COVID acute and chronic lung conditions, including pulmonary sarcoidosis; Nexodyn for management of hard-to-heal ulcers; and programs associated with urea-cycle disorders and maple syrup urine disease through its collaboration with Acer Therapeutics. The company's portfolio therefore combines internally developed and partnered prescription medicines, specialty-care products, clinical-stage assets, and products obtained through acquisitions. Its defining positioning is the pursuit of treatments for severe or rare conditions where established options are inadequate, although the status and commercial prospects of individual programs vary by regulatory jurisdiction and stage of development.

Relief Therapeutics emerged from a corporate and scientific lineage associated with Mondobiotech, a biotechnology company founded in 2000 by Fabio Cavalli and Dorian Bevec. Mondobiotech investigated vasoactive intestinal peptide, a naturally occurring peptide first identified in the 1970s. The company later obtained United States and European patents for a synthetic form of the peptide, aviptadil, in 2006. Relief Therapeutics itself was founded in 2013 by Gael Hédou to pursue treatments for diseases with significant unmet medical need. In June of that year, Mondobiotech merged with Italian pharmaceutical company Pierrel Research International. The transaction created Therametrics, a contract research organization that retained the relevant research and intellectual-property activities. In July 2016, Therametrics merged with Relief Therapeutics, forming Relief Therapeutics Holdings AG and transferring the aviptadil patent portfolio into the combined company. The business was listed on the SIX Swiss Exchange in 2016 under ticker RFLB.S. The company expanded its operating base through acquisitions. In July 2016, it acquired FirstString Research, a clinical-stage biotechnology company based in Charleston, South Carolina. In January 2021, Relief acquired German company AdVita in a transaction reported at €25 million, supporting development of inhaled treatments for acute respiratory distress syndrome. In May 2021, it acquired Applied Pharma Research, a Swiss biotechnology company, for CHF 72 million. APR contributed existing products and pipeline programs, including Sentinox, Nexodyn, and phenylketonuria-related products. The COVID-19 pandemic made Relief's aviptadil program its most prominent development effort. RLF-100 is a synthetic form of aviptadil that Relief described as having lung-protective potential. In June 2020, the FDA granted the candidate fast-track designation for respiratory distress related to COVID-19. Relief then entered a collaboration with NeuroRx, later NRx Pharmaceuticals, to co-develop the medicine and organize clinical trials in the United States. The development program used the name Zyesami for a reformulated version of aviptadil, which was included in an NIH-sponsored Phase 3 study in 2021. Regulatory and legal developments followed. NRx submitted an emergency-use request to the FDA in May 2021 for use in intensive-care patients. The FDA declined the request in November 2021 but stated that it would continue working with the developers. Later that month, NRx announced an analysis reporting a fourfold increase in 60-day survival for patients receiving Zyesami compared with placebo. Relief and NRx subsequently entered a public legal dispute. On October 7, 2021, Relief filed a lawsuit against NRx and its chief executive Jonathan Javitt in the Supreme Court of the State of New York, alleging breaches of the collaboration agreement. Relief's wider portfolio has included respiratory, wound-care, rare-disease, and metabolic products. Applied Pharma Research reported positive interim data in October 2021 for Sentinox, a nasal spray designed to reduce viral load in people with COVID-19. APR also launched PKU GOLIKE KRUNCH, a chewable product for phenylketonuria management, in Germany and Italy in September 2021. Nexodyn was being developed for hard-to-heal ulcers requiring prolonged treatment. Through its collaboration with Acer Therapeutics, Relief was connected to ACER-001, a candidate for urea-cycle disorders and maple syrup urine disease; Acer filed a United States New Drug Application in 2021. Relief has also continued investigating RLF-100 for non-COVID respiratory conditions, including acute and chronic lung diseases such as pulmonary sarcoidosis. Across its corporate history, the company has combined internally developed programs, inherited intellectual property, collaborations, acquisitions, and specialty products. Its central strategic theme has been to address serious conditions for which available treatment options are limited, although individual programs have remained subject to clinical, regulatory, and commercial uncertainty.

• 2021

  Relief acquires AdVita

  [1]Relief Therapeuticsen.wikipedia.org

  Relief acquired AdVita to advance inhaled treatments for acute respiratory distress syndrome.

• 2021

  Relief acquires Applied Pharma Research

  [1]Relief Therapeuticsen.wikipedia.org

  The acquisition added APR's products and pharmaceutical-development pipeline to Relief's business.

• 2020

  RLF-100 receives FDA fast-track designation

  [1]Relief Therapeuticsen.wikipedia.org

  The FDA granted fast-track designation to RLF-100 for respiratory distress associated with COVID-19.

• 2016

  Therametrics merges with Relief Therapeutics

  [1]Relief Therapeuticsen.wikipedia.org

  The merger created Relief Therapeutics Holdings AG and transferred aviptadil-related patents into the combined company.

• 2016

  Relief acquires FirstString Research

  [1]Relief Therapeuticsen.wikipedia.org

  Relief acquired the Charleston-based clinical-stage biotechnology company FirstString Research.

• 2013

  Relief Therapeutics is founded

  [1]Relief Therapeuticsen.wikipedia.org

  Gael Hédou founded Relief Therapeutics to develop therapies for diseases with high unmet medical need.

• 2013

  Mondobiotech and Pierrel Research International merge

  [1]Relief Therapeuticsen.wikipedia.org

  The companies merged to form Therametrics, a contract research organization.

• 2006

  Aviptadil patents granted

  [1]Relief Therapeuticsen.wikipedia.org

  Mondobiotech received United States and European patents for a synthetic version of vasoactive intestinal peptide known as aviptadil.

• 2000

  Mondobiotech is founded

  [1]Relief Therapeuticsen.wikipedia.org

  Fabio Cavalli and Dorian Bevec founded Mondobiotech, the earlier biotechnology company whose research lineage later became associated with Relief Therapeutics.

A specialty biopharmaceutical company targeting serious, rare, and underserved diseases, with emphasis on respiratory medicine, rare metabolic disorders, and differentiated pharmaceutical products.

• Respiratory biopharmaceutical

  RLF-100

  RLF-100 is Relief's development name for aviptadil, a synthetic form of vasoactive intestinal peptide. The candidate became the company's principal COVID-19-era program and was investigated for severe respiratory distress and acute lung disease. A reformulated version was referred to as Zyesami in the United States development program. Relief has also described ongoing research into non-COVID respiratory conditions, including pulmonary sarcoidosis.

• Nasal spray

  Sentinox

  Sentinox is a nasal spray developed by Applied Pharma Research and associated with Relief following the 2021 acquisition of APR. The product was studied for its ability to reduce viral load in people with COVID-19, with the broader objective of potentially reducing transmissibility. APR announced positive interim clinical data in October 2021.

• Phenylketonuria nutritional product · 2021

  PKU GOLIKE KRUNCH

  PKU GOLIKE KRUNCH is a chewable product associated with Applied Pharma Research for the dietary management of phenylketonuria. It was launched in Germany and Italy in September 2021 and formed part of the portfolio acquired by Relief through APR.

• Wound-care product

  Nexodyn

  Nexodyn is a product under development for the management of hard-to-heal ulcers that require extended treatment. It entered Relief's broader portfolio through Applied Pharma Research, which was developing the product before its acquisition by Relief.

• Rare-disease pharmaceutical

  ACER-001

  ACER-001 is a product candidate developed by Acer Therapeutics and connected to Relief through a collaboration. The program targets urea-cycle disorders and maple syrup urine disease. Acer filed a New Drug Application with the United States FDA in 2021.

• 2021

  Aviptadil collaboration lawsuit

  Relief Therapeutics filed a lawsuit in New York against NRx Pharmaceuticals and its chief executive Jonathan Javitt, alleging multiple breaches of the companies' agreement concerning the co-development of aviptadil. The allegations were part of a commercial dispute and are not presented here as established findings of wrongdoing.

  Source

Read more

• 2021

  Acquire AdVitaM&A

  Background

  Relief sought to strengthen its respiratory pipeline, particularly inhaled treatments for acute respiratory distress syndrome.

  Action taken

  Relief acquired German company AdVita in an agreement reported at €25 million.

  Aftermath

  The transaction expanded Relief's research activities in inhaled respiratory therapies.

  Transaction value. €25 million (January 2021)

  Source

• 2021

  Acquire Applied Pharma ResearchM&A

  Background

  Relief aimed to broaden its portfolio beyond the aviptadil program and obtain commercial products and development assets.

  Action taken

  Relief acquired Swiss biotechnology company Applied Pharma Research and its existing portfolio and pipeline.

  Aftermath

  The acquisition added Sentinox, PKU GOLIKE KRUNCH, Nexodyn, and other pharmaceutical-development activities to Relief's portfolio.

  Transaction value. CHF 72 million (May 2021)

  Source

• 2021

  Launch PKU GOLIKE KRUNCHProduct launch

  Background

  Applied Pharma Research had developed a chewable product for people managing phenylketonuria.

  Action taken

  APR launched PKU GOLIKE KRUNCH in Germany and Italy.

  Aftermath

  The launch became part of the product portfolio later incorporated into Relief through the APR acquisition.

  Source

• 2020

  Prioritize aviptadil for severe COVID-19 respiratory diseaseStrategy

  Background

  The COVID-19 pandemic created an urgent need for therapies addressing severe respiratory complications, and Relief had an aviptadil-based candidate with a lung-focused research rationale.

  Action taken

  Relief pursued FDA fast-track designation and partnered with NeuroRx to coordinate United States development and clinical trials for RLF-100.

  Aftermath

  The program advanced into clinical and regulatory review but the FDA declined emergency authorization in 2021.

  Source

• Unconfirmed

  MGAC acquires RLF[2]MGAC收购RLFheraldscotland.com

  Reported: 2021-10-13

  MGAC acquired construction consultancy RLF in an undisclosed all-cash deal. The article also reports leadership changes at RLF following the acquisition.

1. 1Relief Therapeuticsen.wikipedia.org
2. 2MGAC收购RLFheraldscotland.com