Archivel Farma continues its fight against tuberculosis. The Spanish biotech company has promoted the design and launch of a Phase IIb clinical trial to explore the efficacy and safety of concomitant administration of Ruti immunotherapy with standard treatment in patients with pulmonary tuberculosis (pulmonary TB). For this trial, which is called Constan, more than half a million euros are being invested, according to Olga Rué, CEO of Archivel Farma.
This clinical trial is being promoted with Cristina Vilaplana, head of the experimental tuberculosis unit at the Germans Trias i Pujol Institute in Badalona (Barcelona), as principal investigator. The study has been approved by the Spanish Agency of Medicines and Health Products (Aemps) and plans to include the first patient in January 2022.
The trial, led by Archivel Farma, will be conducted in collaboration with the microbiology service of the Germans Trias i Pujol Hospital. Eight Catalan healthcare centers will participate in the recruitment of 56 patients: Hospital Germans Trias i Pujol, Hospital Universitari Vall d’Hebron, Hospital Clínic de Barcelona, Serveis Clínics, Hospital de Sant Pau i la Santa Creu, Hospital Moisès Broggi, Hospital Universitari Mútua de Terrassa and Hospital Parc de Salut Mar.
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Archivel is testing Ruti in two trials, in Ukraine and India
If proven effective, this new therapeutic option could be used as a first-line treatment in newly diagnosed patients with pulmonary TB, with the aim of reducing the bacillary burden in the lung more rapidly than the current standard treatment alone.
Furthermore, the aim of the Constan trial is to explore the efficacy of the Ruti vaccine for this purpose, while assessing that this schedule of administration is safe for patients. In parallel, Ruti is also being administered in two other clinical trials as an adjuvant TB treatment in Ukraine and India, the latter under the European STriTuVaD Consortium funded by the European Commission under the Horizon 2020 program.
Globally, TB is the second leading cause of infectious disease mortality after Covid-19, responsible for the death of 1.5 million people during 2020 and ten million new patients each year. Some 25% of the world’s population is infected and of this, 10% could develop the disease at some point in their lives. Resistance to antibiotics used as the first line of treatment for tuberculosis has become a serious problem (only 60% of patients are cured) that could be improved if treatments were shorter, favoring compliance since lack of adherence is one of the main causes of the generation of resistance.
25% of the world’s population is infected with tuberculosis
In this context, the Ruti vaccine could help to eliminate the bacillary load more quickly, accelerating cure and, consequently, reducing antibiotic treatment time. This would help prevent and better control recurrences, new resistances, and the spread of infections. Ruti is also being evaluated for the prevention of Covid-19 in a clinical trial with 250 volunteers in Argentina by Ruti Immunotherapeutics. Ruti Immunotherapeutics acquired exclusive worldwide rights to use the vaccine for the treatment and prevention of viral infections and in December 2020 closed a financing round through the Capital Cell platform.
Archivel Farma is a biotech company founded in 2005 in Barcelona by Jose Martinez, who was its main investor until 2011. Its activity is focused on the development of the Ruti vaccine, a biological product devised by Pere Joan Cardona, from the Institut d’Investigació Germans Trias i Pujol, to treat tuberculosis (especially antibiotic-resistant tuberculosis) and other diseases susceptible to immunomodulatory interventions.
The company’s objective is to develop the Ruti vaccine for different indications up to advanced clinical stages and to license it to pharmaceutical companies that can bring it to the market, making it accessible to the greatest number of people. It currently has a team of more than twenty professionals and has its own certified manufacturing plant for the production and release of sterile and biological investigational products, their packaging, and quality control.
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First published in PlantaDoce, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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