Here a DeepL translation of today's printed article of the swiss "Finanz und Woche" newspaper. (dated 7th november 20)
Note: "Finanz und Woche" (FuW) is considered critical or even negative towards Relief.
Relief recovering after positive report
The biotech company can continue its corona study after an interim analysis. It is refusing a recommendation to sell its shares.
The committee, which is monitoring the execution of the study with the active substance RLF-100, has given the green light for the continuation of the corona development project. This was announced by Relief Therapeutics on Thursday.
The Data Monitoring Committee evaluated data from 102 randomly selected patients observed for at least 28 days and concluded that the study with the potential drug from the Geneva-based company has a good chance of success. The decision of the seven scientists on the committee was unanimous. Relief has thus survived the second interim analysis.
A first one with the data of thirty patients had shown a positive data trend. Otherwise, the committee would have demanded the discontinuation of the study. Relief's shares rose by around 50% on Thursday and Friday.
Uncertainty remains
They are still 20% lower than at the beginning of the week. The stocks were under pressure on Tuesday and Wednesday. The trigger was probably an article in "Finanz und Wirtschaft". This mentioned, among other things, a sell recommendation by Olav Zilian, a pharmaceutical analyst at Mirabaud Securities, from the previous day. The recommendation was triggered by the study stop for a possible competitor product that Zilian considers similar. Relief Chairman Ram Selvaraju contradicts: "The molecules of the two companies had a different mechanism of action (see box on controversy).
Relief's share price is based on the hope that the anti-inflammatory RLF-100 can help seriously ill corona patients. If the ongoing Phase IIb/III study does not show efficacy, the share price is likely to plummet. The results are now expected in January.
The fact that the share price has not rebounded to its previous level may also be due to the fact that investors had expected more from the decision of the Monitoring Committee. With exceptionally good data, it would have recommended the early termination of the study. The partner company NeuroRx already submitted an application for emergency approval in the USA at the end of September. A very likely positive decision by the US Food and Drug Administration (FDA) in a few days would have been realistic. Now the waiting continues. It remains uncertain how well RLF-100 actually works.
Details of the interim analysis will not be published. Only the members of the monitoring committee saw them. The unanimous decision to continue the study shows that obviously nobody seriously doubted the success of the study - the proof of efficacy with acceptable side effects. RLF-100 apparently showed a data trend in the second interim analysis, which could range from rather weak to very good, but not outstanding. If the signal was weak, it is possible that the compound may ultimately fail to reach statistical significance.
Secondary goals also count
Approval would also be conceivable in this case. RLF-100 could also achieve individual secondary goals such as accelerated recovery, shortening the duration of artificial respiration or improving the oxygen content of the blood. Gilead's Remdesivir has received emergency approval after showing faster recovery.
The interim result of the Phase IIb/III study suggests that relief is unlikely to be a miracle cure, but it may help seriously ill patients. That would be progress. The chances of commercial success may have been somewhat diminished on Thursday, but they remain intact. The shares of Relief Therapeutics remain risky. An engagement is reserved for players.
Chairman of the Board of Directors Selvaraju and bank analyst Zilian in duel
Following the stock crash, Olav Zilian, the analyst from Mirabaud Securities, who most likely triggered it with a sell recommendation, and Ram Selvaraju, Chairman of the Board of Directors of Relief, engaged in controversy.
The trigger for the sell recommendation was the study stop due to the hopelessness of PhaseBio's pemziviptadil. Zilian considers it to be very similar to Relief's RLF-100, while Selvaraju, himself a pharmaceutical analyst and Managing Director at broker H. C. Wainwright, points out crucial differences, especially the mechanism of action.
The focus is on the relevant receptors on the cells, VPAC1 and VPAC2. According to PhaseBio, the active ingredient pemziviptadil docks selectively to the VPAC2 receptor. RLF-100, however, binds rather strongly to both receptors. Relief's hypothesis is that the ability to bind a VIP-analog molecule to VPAC1 is crucial for influencing the course of disease in Covid-19 or other patients with respiratory problems. VIP means vasointestinal peptide. VPAC1 is important because these receptors are expressed on type 2 pneumocytes. These play a critical role in Covid-19.
Zilian, however, doubts that the two peptide chains are actually different. RLF-100 corresponds to naturally occurring VIP, and PhaseBio calls its pemziviptadil a fusion molecule between natural human VIP and a molecule that extends its half-life. In addition, RLF-100 binds to both receptors quite strongly, and PhaseBio does not refer to any data on its website to support its claim. It is not known to what extent the PhaseBio compound binds primarily to VPAC2.
Selvaraju also points out that RLF-100 may affect several processes. For example, there is evidence of an antiviral effect of RLF-100, and it could also protect the aforementioned type 2 pneumocytes in the lungs. This may even be crucial for the VRP. This is because these cells produce a mucus that is essential for oxygen exchange. The Chairman emphasizes that the relief compound has passed both the first and second interim analysis of the Phase IIb/III study without any problems. PhaseBio did not even pass the first one.
However, Zilian believes that the ongoing Phase llb/III study would have been stopped if it had generated very convincing results. He also assumes that the increase in the targeted number of patients from 144 to 165 is an indication of an initially less pronounced data trend. Selvaraju replied that the early termination of the study was a hurdle that was extremely difficult to overcome. The increase in the number of study participants had been encouraged by the U.S. Food and Drug Administration (FDA) even before the first interim analysis.
Written by RUPEN BOYADJIAN
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