Milestone “last patient out” reached – the clinical phase of the second study with …

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27.07.2023 – 14:48

G. Pohl-Boskamp GmbH & Co. KG

Hohenlockstedt (ots)

The pharmaceutical company Pohl-Boskamp today ended the treatment phase of the last patient recruited (last patient out) of the COVARI-2 study and thus completed the clinical phase of the study. The first results are expected in October 2023. In this study, ELOM-080, the active ingredient of the respiratory drug GeloMyrtol® forte, is being investigated in the therapy of outpatient COVID-19 patients with pronounced acute cough symptoms.

In less than four months, Pohl-Boskamp included 120 patients with typical COVID-19 symptoms, who also have pronounced acute cough symptoms, in the double-blind, placebo-controlled, multi-centre phase 2 study (EudraCT 2022-003478-22). The clinical phase of the study was completed today with the end of treatment for the last recruited patient. The study data will be unblinded in October 2023, so that results can be expected in the following month.

endemic with consequences

In mid-July, the Federal Ministry of Health recorded an 18 percent increase in the seven-day incidence and a 153 percent increase in sites with increasing viral loads in wastewater. Especially in the last few months, respiratory infections such as COVID-19 have been a frequent reason for visiting a doctor. In July, the number of respiratory diseases with Covid-19 diagnosis increased by 83 percent. After the isolation requirement has been lifted and official tests have been carried out, only relatively few Covid-19 cases are reported, so that the percentage increases relate to small numbers. But Corona has not disappeared and the affected patients often suffer from the symptoms for a long time. Evidence-based therapy options for COVID-19 diseases for general practitioners and guideline recommendations are still missing [1] reduce outpatient therapy options to a few antiviral agents or to supportive measures. The COVARI-2 study aims to answer the question of whether the use of ELOM-080 can improve the course of the disease in outpatients suffering from COVID-19. The course of the cough symptoms is examined in terms of frequency and severity as well as the development of other typical COVID-19 symptoms. This was preceded by the COVARI study published in 2022 on hospitalized patients suffering from COVID-19 who required oxygen and which resulted in conclusive signals for further investigation of the herbal active ingredient in outpatients with COVID-19. This study showed that the patients who were additionally treated with ELOM-080 required significantly less additional oxygen as early as the 2nd week of hospitalization. In addition, the patients in the ELOM-080 group suffered significantly less from shortness of breath during exertion (e.g. when climbing stairs) after discharge.

Focus on mucociliary clearance

Current research results from well-known institutes show that the mucociliary clearance (MCC), the self-cleaning mechanism of the airways, can be impaired, overloaded, damaged or largely non-functional in the early phase of COVID-19 disease [2],[3],[4],[5],[6],[7]. One possibility to have a positive effect on the course of the disease could be to maintain or restore mucociliary clearance in order to counteract an aggravation or spread of the infection in the airways. “Earlier studies have already shown that ELOM-080 causes an enhancement of the MCC [8]”, comments Dr. Thomas Wittig, General Practitioner and Head of Medicine & Clinical Research at Pohl-Boskamp, ​​on the company’s research commitment. The phytotherapeutic agent improves the natural protection and cleaning mechanism down to the deep airways. The activity of the cilia is significantly increased (secretomotoric) , which liquefies tough mucus and stimulates the production of thinner mucus (mucosecretolytic) [9],[10],[11],[12]. As a result, the secretion with adhering viruses and bacteria is transported away more quickly.

ELOM-080 as a therapy option for acute COVID-19 courses?

Pohl-Boskamp is optimistic and hopes for promising results that can be used in the outpatient treatment of COVID-19. Continuing research with the active ingredient ELOM-080 could provide physicians and patients with therapy for the symptomatic treatment of COVID-19 disease in the long term.

[1]Blankenfeld H et al. SARS-CoV-2/COVID-19 Information. DEGAM Guideline 2022 (Version 23). [2] Li Q et al. JCI Insight. 2023;8(1):e163962 [3] Schreiner T et al. Int. J. Mol. Sci. 2022, 23, 5124 [4] Bridges JP et al., Thorax 2022;77:203-209 [5] Kandemir S & Pamuk AE, Laryngol Otol 2022;1-5 [6] Ozturk EO et al., Acta Oto-Laryngologica 2022; 142: 329-3 [7] Robinot R et al. Common Nat. 2021 Jul 16;12(1):4354 [8] Wittig T: MMW Fortschr Med. 2021;163(Suppl 5): 21-27. [9] App EM. In: Master R. Inflammatory diseases of the bronchial system. jumper; 2000:27-53 [10] Beuscher N, et al. Journal of Phytotherapy, abstract volume, 8th Congress of the Society for Phytotherapy 1997: 9-10 [11] Begrow F, et al. Adv Ther 2012;29: 350-358 [12] Lai Y et al. American Journal of Rhinology & Allergy. 2014; 28(3): 244-2

Press contact:

G. Pohl-Boskamp GmbH & Co. KG
Claudia Rohlfs
Kieler Strasse 11
25551 Hohenlockstedt
Tel.: +49 (0) 4826 59 462
Fax: +49 (0) 4826 59-419
E-Mail: [email protected]

Original content from: G. Pohl-Boskamp GmbH & Co. KG, transmitted by news aktuell