Continuing our emphasis on finding small-cap winners that large-cap investors need to focus on, we are turning our attention to BioCryst Pharmaceuticals. Matter of fact, for Gilead investors, focused on Remdesivir, they should focus on Biocryst and Galidesivir. Right now, the market is just waiting for good news to hit the tape before BioCryst Pharmaceuticals stock breaks out.
About BioCryst Pharmaceuticals
First up, here’s a little background info for those that aren’t familiar with BioCryst Pharmaceuticals. BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease.
BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressive.
RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea, and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.BioCryst.com.
Galidesivir, a broad-spectrum antiviral drug, is an adenosine nucleoside analog that acts to block viral RNA polymerase. It is in advanced development for the treatment of COVID-19, Marburg virus disease and Yellow Fever.
Phase 1 clinical safety and pharmacokinetics trials of galidesivir by both intravenous and intramuscular routes of administration in healthy subjects have been completed. In animal studies, galidesivir has demonstrated activity against a variety of serious pathogens, including Ebola, Marburg, Yellow Fever, and Zika viruses.
Galidesivir has also demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including coronaviruses, filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, and flaviviruses. BioCryst is developing galidesivir in collaboration with U.S. government agencies and other institutions.
Galidesivir is an investigational broad-spectrum antiviral drug that was safe and well-tolerated in previously reported Phase 1 trials in healthy subjects. Galidesivir has demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including the coronaviruses that cause MERS and SARS. A Phase 1 trial to assess the safety, clinical impact, and antiviral effects of galidesivir in patients with COVID-19 is currently enrolling patients across multiple sites in Brazil.
BioCryst Pharmaceuticals Phase 1 Trial Design
Part 1 of the trial will enroll 24 hospitalized adults diagnosed with moderate to severe COVID-19 confirmed by PCR. Three cohorts of eight patients will be randomized to receive intravenous (IV) galidesivir (n=6) or placebo (n=2) every 12 hours for 7 days.
Upon completion of part 1 of the trial, an optimized dosing regimen of galidesivir will be selected for part 2 of the trial, based on part 1 results including safety, viral load reduction in respiratory tract secretions, improvement in COVID-19 signs and symptoms and clinical manifestations, and mortality.
In part 2 of the trial, up to 42 hospitalized patients with COVID-19 will be randomized 2:1 to receive IV galidesivir or placebo. After treatment, the patients will remain hospitalized until resolution of COVID-19 symptoms allows release. All patients will be followed for mortality through Day 56.
Remedesivir vs Galidesivir
Remdesivir & galidesivir have similar mechanisms for attacking COVID-19. However, Galidesivir is almost identical to natural ATP docking energy that COVID-19 uses. Galidesivir is given in pill form, intravenously or intramuscular, Remdesivir is IV only. Galidesivir has a strong safety profile, is not toxic, can use much higher doses, no side effects & results in superior tissue saturation to battle COVID-19. Also cheaper & easier to manufacture.
Data from the first part of the study should be hitting the tape fairly soon. Since the most recent clinical trial update added additional clinical trial sites, BioCryst Pharmaceuticals should be able to enroll the second part of the study immediately. With almost $200 million in the bank and no shortage of patients in Brazil needing treatment, we are just a pr away from BioCryst Pharmaceuticals stock making a huge move, especially with 15% of the float short.
As always, good luck to all (except the shorts)!
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Disclosure: We have no position in NASDAQ:BCRX or any of the securities mentioned. We wrote this article ourselves and it expresses our own opinions. We are not receiving compensation for it. We have no business relationship with any company whose stock is mentioned in this article.