BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) Files An 8-K Other Events
Item 8.01. Other Events.
On October 28, 2019, BioCryst Pharmaceuticals, Inc. (the “Company”) announced results from an ongoing three-part Phase 1 trial of BCX9930, an oral Factor D inhibitor discovered and developed by the Company for the treatment of complement-mediated diseases, in 72 healthy volunteers. BCX9930 was safe and generally well tolerated, and showed rapid, sustained and >95% suppression of the alternative pathway (“AP”) of the complement system at 100 mg every 12 hours, as measured by the AP Wieslab assay.
Based on the safety, tolerability, pharmacokinetic and pharmacodynamic dose-response results from parts 1 and 2 of the Phase 1 trial, the company plans to complete additional multiple ascending dose dosing cohorts and advance to part 3 of the trial, a proof of concept (“PoC”) study of BCX9930 in paroxysmal nocturnal hemoglobinuria (“PNH”) patients who are poor responders to eculizumab or ravulizumab, and treatment-naïve patients. The company expects to report data from the PoC study in PNH patients in the first half of 2020.
On October 28, 2019, the Company issued a news release announcing the events described in this Item 8.01, which also referenced a conference call and webcast to discuss these recent corporate developments. A copy of the news release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that the development of BCX9930 may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930 may not advance as expected, enroll the required number of subjects or have positive results; that further analysis of the current data or from additional data from the study may yield results which are different from our current view; that the FDA, EMA or other applicable regulatory agency may not agree with our interpretation, may require additional studies beyond the studies planned, may not provide regulatory clearances, may impose a clinical hold or may withhold market approval with respect to BCX9930. Please refer to the documents the Company files periodically with the Securities and Exchange Commission, specifically the Company’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in the Company’s projections and forward-looking statements.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| 99.1 | Press release dated October 28, 2019 entitled “BioCryst Reports Data from Phase 1 Trial of BCX9930 and Announces Plans to Advance Program into Proof of Concept Study in PNH Patients” |
BIOCRYST PHARMACEUTICALS INC Exhibit
EX-99.1 2 exh_991.htm PRESS RELEASE EdgarFilingEXHIBIT 99.1BioCryst Reports Data From Phase 1 Trial of BCX9930 and Announces Plans to Advance Program Into Proof of Concept Study in PNH Patients —Phase 1 data showed rapid,…
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About BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX)
BioCryst Pharmaceuticals, Inc. (BioCryst) is a biotechnology company. The Company designs, optimizes and develops small molecule drugs that block enzymes involved in the pathogenesis of diseases. The Company focuses on the treatment of rare diseases. The Company uses X-ray crystallography, computer modeling of molecular structures and chemistry techniques to focus on the three-dimensional molecular structure and active site characteristics of the enzymes that control cellular biology. Its drug candidates include RAPIVAB, RAPIACTA, PERAMIFLU, Avoralstat, BCX7353, other second generation hereditary angioedema (HAE) compounds, BCX4430 and Forodesine. Its product RAPIVAB contains peramivir. Peramivir is an intravenous neuraminidase inhibitor approved in various countries for the treatment of patients with influenza, in the United States as RAPIVAB. RAPIVAB is used for the treatment of acute uncomplicated influenza. Its BCX4430 is a broad-spectrum antiviral (BSAV) research program.
