AZN Pauses COVID-19 Vaccine Trial, ALBO Hits New High, CRBP Plunges, PFE To Invest In TRIL
Today’s Daily Dose brings you news about AstraZeneca pausing its phase 3 study of COVID-19 vaccine candidate, Albireo’s positive data from phase 3 trial of Odevixibat in progressive familial intrahepatic cholestasis, Corbus’ disappointing results from its phase 3 trial of Lenabasum in diffuse cutaneous systemic sclerosis, RedHill’s promising ‘in vitro’ data of COVID-19 drug candidate, Spero’s ADAPT-PO trial results and Pfizer’s equity investment in Trillium.
1. AstraZeneca Pauses COVID-19 Vaccine Trial
AstraZeneca PLC (AZN) has paused the phase III study of its COVID-19 vaccine candidate, AZD1222, following an adverse reaction in a trial participant, reports Stat News.
AZD1222, being developed by AstraZeneca and the University of Oxford researchers, is in phase III development in the U.S., UK, Brazil, and South Africa with additional trials planned to start in Japan and Russia.
The U.S. has recorded 6,326,696 active cases of COVID-19 and 189,639 deaths as of this writing, according to the Johns Hopkins University database.
AZN closed Tuesday’s trading at $54.71, up 2.11%. In after-hours, the stock was down 8.14% at $50.25.
2. Albireo Pharma Soars to New High
Shares of Albireo Pharma Inc. (ALBO) jumped as much as 79 percent to touch a new 52-week high of $49 in intraday trading Tuesday, following positive topline results from a global phase III clinical trial of Odevixibat in progressive familial intrahepatic cholestasis of type 1 or type 2, a rare genetic liver disease.
In the phase III trial, dubbed PEDFIC 1, the two primary endpoints namely reductions in pruritus and serum bile acids achieved highly statistical significance with Odevixibat. The investigational drug was also well tolerated with a very low incidence of diarrhea.
The company is planning to complete regulatory filings for Odevixibat in the indication of progressive familial intrahepatic cholestasis in the EU and in the U.S. by early 2021.
In other news, the company announced that it has commenced a proposed underwritten public offering of 3 million shares of its common stock.
ALBO closed Tuesday’s trading at $39.62, up 44.76%.
3. Co-Diagnostics to Expand COVID-19 Testing Services
Co-Diagnostics Inc. (CODX) has entered into an agreement with Arches Research Inc, a CLIA laboratory and subsidiary of Polarity TE, Inc, (PTE), to expand COVID-19 testing services.
Co-Diagnostics’ Logix Smart COVID-19 test, which is CE-marked and authorized for emergency use by the FDA, is used for the diagnosis of SARS-CoV-2, the virus that causes COVID-19, in the US and many other countries.
Arches Research has been using Co-Diagnostics’ tests for its customers since early this year.
CODX closed Tuesday’s trading at $11.70, up 41.99%.
4. Corbus Pharma Plunges on Disappointing Trial Results
Corbus Pharmaceuticals Holdings Inc. (CRBP) plunged more than 75% on Tuesday, following disappointing results from its phase III trial of Lenabasum in patients with diffuse cutaneous systemic sclerosis.
Systemic sclerosis, a form of scleroderma, is a chronic, rare, debilitating autoimmune disease affecting about 200,000 people in the North America, EU, and Japan.
The median American College of Rheumatology Combined Response Index for Systemic Sclerosis (ACR CRISS) scores at Week 52 that reflects the probability of patient improvement was set as the primary endpoint of the trial.
In the phase III trial, dubbed RESOLVE-1, there were no significant differences in the primary and secondary endpoints when comparing Lenabasum to placebo, both added to background immunosuppressive drugs.
CRBP closed Tuesday’s trading at $2.23, down 75.89%.
5. RedHill Rallies on Promising In vitro Data of COVID-19 Drug Candidate
RedHill Biopharma Ltd.’s (RDHL) drug candidate Opaganib has demonstrated complete inhibition of SARS-CoV-2, the virus that causes COVID-19, in an in vitro model of human lung bronchial tissue comparing favorably with Gilead Inc’s (GILD) Remdesivir.
It should be noted that Remdesivir has received FDA’s emergency use authorization to treat all hospitalized patients with Covid-19.
RedHill’s Opaganib is under a global Phase 2/3 study in patients with severe COVID-19 pneumonia as well as in a phase 2 study in patients with severe COVID-19 pneumonia in the U.S.
RDHL closed Tuesday’s trading at $8.41, up 13.04%.
6. Spero Therapeutics Gets a Boost from ADAPT-PO Trial Results
Spero Therapeutics Inc.’s (SPRO) pivotal phase III clinical trial of oral antibiotic candidate, Tebipenem HBr, has yielded positive results in the treatment of adults with complicated urinary tract infection (cUTI) and acute pyelonephritis.
In the phase III study, dubbed ADAPT-PO, oral Tebipenem HBr was statistically non-inferior to Merck’s approved intravenous (IV) Ertapenem in the treatment of patients with cUTI and patients with acute pyelonephritis.
Spero intends to complete NDA submission for U.S. regulatory approval of Tebipenem HBr in the second quarter of 2021.
SPRO closed Tuesday’s trading at $13.07, up 45.87%. In after-hours, the stock gained another 1.07% to $13.21.
7. Strongbridge Biopharma Slumps despite LOGICS study Achieving Main Goal
Strongbridge Biopharma plc’s (SBBP) phase III withdrawal study evaluating RECORLEV for the treatment of endogenous Cushing’s syndrome, dubbed LOGICS, has met the primary endpoint with high statistical significance. However, shares fell more than 20%, following the results.
At the end of the withdrawal phase of the LOGICS study, 54.5 percent more patients who were withdrawn to placebo had a loss of mean urinary free cortisol response as compared with those who remained on RECORLEV, noted the company.
The adverse events of special interest in the LOGICS study included those that were liver-related, those related to adrenal insufficiency, and QT interval prolongation.
The company is planning to submit a New Drug Application for RECORLEV to the FDA in the first quarter of 2021.
SBBP closed Tuesday’s trading at $2.82, down 20.11%.
8. Trillium Gets equity investment from Pfizer
Trillium Therapeutics Inc. (TRIL) soared more than 38 percent in after-hours Tuesday, following a proposed equity investment from Pfizer Inc. (PFE) via a registered direct offering.
The company has agreed to sell 2.29 million common shares at a price of $10.88 per share to Pfizer for gross proceeds of $25.0 million. The offering is expected to close on or about September 10, 2020.
Trillium’s lead candidates include TTI-621, under a phase 1 study in patients with advanced relapsed or refractory hematologic malignancies, and TTI-622, which is being evaluated in a phase 1a/1b study in patients with advanced relapsed or refractory lymphoma or multiple myeloma.
TRIL closed Tuesday’s trading at $9.46, down 1.77%. In extended trading, the stock was up 38.48% at $13.10.
9. Stocks That Moved On No News
SCWorx Corp. (WORX) closed Tuesday’s trading at $1.86, up 22.37%.
Cancer Genetics Inc. (CGIX) closed Tuesday’s trading at $5.26, up 21.48%.
TRACON Pharmaceuticals Inc. (TCON) closed Tuesday’s trading at $3.74, up 20.65%.
Biocept Inc. (BIOC) closed Tuesday’s trading at $4.42, down 16.89%.
Venus Concept Inc. (VERO) closed Tuesday’s trading at $2.23, down 16.48%.
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