Several questions remain behind pioneer’s 200% jump in its share price after it announced a successful oral drug trial for COVID-19

2022-07-28 0 By

Reporter | huang hua editing | sechin 14 month 6, open up a new crown for oral administration released its pharmaceutical in research new crown light lu amine treated poke global multicenter phase iii (NCT04870606) key data results.The announcement shows that proklutamine can reduce hospitalizations, mortality, novel coronavirus loads and related COVID-19 symptoms.As soon as the results were released, pioneering pharmaceutical intraday rose more than 200%.As of April 6, the company closed at hk $28.85 a share, up 106.37%.The phase iii data based on a double-blind, placebo-controlled (1:1), randomized, multicenter registered sex global clinical trials, into the group of 733 cases of light in the new crown infection of hospitalized patients (including 727 from the United States and the rest came from other countries), the treatment group oral once a day, 200 mg amine, poke for 14 consecutive days.Proclotamine is an androgen antagonist ACE2 and TMPRSS2 developed by Pioneer Pharmaceuticals, originally intended for the treatment of prostate cancer.In September 2020, Pioneer Pharmaceutical published phase iii data showing a poor outcome of prokluramide in patients with metastatic castration-resistant prostate cancer.Subsequent announcements about the drug’s progress in COVID-19 treatment sent Pioneer’s shares on a roller-coaster ride.The endpoint was the percentage of subjects who had not been hospitalized for ≥24 hours or had been on oxygen for ≥24 hours or died due to peripheral blood oxygen saturation (SpO2) ≤93% by day 28.The incidence of hospitalization or oxygen inhalation for more than 24 hours or death due to peripheral blood oxygen saturation ≤93% within 28 days;Changes in viral load from baseline to day 28 and safety assessment.Popularly understood, 733 patients with MILd-onset COVID-19 were randomly divided into two groups: one group was treated with prokluramide and the other with placebo;The progression of the disease was then compared, and differences in deterioration, admission, and even death were observed between the two groups to determine whether and how effective prokluramide was.Experimental data have shown that prokluramide reduces hospitalization/mortality.There were more hospitalizations and deaths in the control group than in the prokluramide group.In all subjects randomized to take at least 1 day of medication (N=730), there were 8 hospitalization events (including 1 death) in the control group and 4 (no death) in the prokluramide group, respectively, with a corresponding protection rate of 50% (all subjects were hospitalized due to COVID-19).In addition, among subjects who completed treatment for more than 1 day (N=721), there were 7 hospitalization events (including 1 death) in the control group and 2 hospitalization events (no death) in the prokluramide group, with a corresponding protection rate of 71%, the company said in the announcement.Among subjects who completed medication for more than 7 days (N=693), there were 6 hospitalization events (including 1 death) in the control group and 0 (P <0.02) in the prokluramide group, respectively, with a corresponding protection rate of 100%."Protection rate of 100%", perhaps the most can cause pioneering pharmaceutical today intraday soared 200%.However, it should be noted that the primary end point analysis should exclude all bias factors to the extent possible when conducting statistical analyses of clinical trials.In other words, based on the "100% protection rate" in the condition of "more than 7 days of completion of the drug", there are many factors influencing the effect, not all of which are the effect of prokluramide.Therefore, based on the information published so far, it is not objective to conclude on this data that propylamine is 100% effective.On the contrary, if all the random subjects are included in, is the development of pharmaceutical bulletin "in all random and the medicine for at least 1 day of subjects (N = 730), the control group and poke lu group on the number of hospitalized events respectively, 8 cases (including 1 death) and 4 cases (not dead)" this case, lu amine poke the corresponding protection is only 50%,Rather than 100%.In addition, the Discovery announcement stated that a study was conducted on hospitalization/mortality in subjects with high-risk factors.Again, the rate of hospitalization or death in the prokluramide group was better than in the control group.In subjects aged ≥50 years and associated with obesity, prokluramide significantly reduced hospitalization/mortality (P <0.02), with a protective rate of 100%;No hospitalization or death occurred in the puklutrimide group;In subjects aged ≥60 years (with or without underlying disease), prokluramide significantly reduced hospitalization/mortality (P <0.02), with a corresponding protection rate of 100%;No hospitalization or death occurred in the puklutrimide group;In subjects aged ≥60 years with at least one underlying medical condition (e.g., obesity, diabetes, hypertension, etc.), prokluramide significantly reduced hospitalization/mortality (P <0.02), with a corresponding protection rate of 100%;There were no hospitalizations or deaths in the puklutrimide group.However, in the foregoing data, the specific number of participants, hospitalization or death data of each group were not disclosed in the Announcement of Pioneer Pharmaceutical.In theory, a "100% protection rate" could be achieved if there were one or more admissions or deaths in the placebo group and none in the prokluramide group.At the end of December 2021, Pioneer pharmaceutical announced that the interim analysis of the phase III clinical trial of prokluramide did not reach statistical significance, and the company subsequently said that it would adjust the trial protocol to include high-risk patients in the trial.This means that from the end of 2021 to now, the trial has been included in the high-risk population enrollment trial, which is the basis for the current published trial results.Therefore, the development of pharmaceutical industry actually has another part of the content needs to be explained.That is, whether the majority of admissions or deaths in the current trial results were from high-risk groups, thus accounting for the significant difference between the control and prokluramide groups.In addition, the announcement of Kaikai pharmaceutical indicated that the novel coronavirus load in the puklutamide treatment group was significantly and continuously decreased from day 3 to day 28 compared with the control group (day 3 and day 28, P <0.01).Furthermore, proklumide improved COVID-19 related symptoms, and the proklumide group improved some COVID-19 related symptoms such as fever, shortness of breath, and cough better than the control group, and the improvement continued to be better than the control group until at least day 28.However, in a number of novel Coronavirus studies that do not involve proklutamine, it has been shown that the novel coronavirus load gradually decreases in the human body, resulting in remission of the corresponding symptoms.Moreover, the incidence of adverse events is increasing due to the use of prokluramide.Pioneer Pharmaceutical announced that the results of this trial showed that the overall tolerability of the treatment of patients with MILD to moderate COVID-19 was good, safe and controllable.However, the incidence of adverse events was 7.9% in the control group and 9.6% in the prokluramide group, respectively.Most of them were mild. The most common adverse event was vertigo (1.1% in both the control group and the prokluramide group), and the incidence of any of the other adverse events was <1%.There were no serious adverse events.