Item 8.01 Other Events.
On March 4, 2019, Apellis Pharmaceuticals, Inc. (the “Company”) announced that with the agreement of the independent safety monitoring committee for the Company’s Phase 3 clinical program forAPL-2 in patients with geographic atrophy (“GA”), the Company has resumed enrollment its two Phase 3 clinical trials in patients with GA (DERBY and OAKS) with intravitrealAPL-2. The Company continues to expect that both trials will be fully enrolled by the end of the first quarter of 2020.
In October 2018, the Company announced that it had voluntarily implemented a pause in dosing in the DERBY and OAKS Phase 3 trials due to observed cases ofnon-infectious inflammation in patients treated from a single manufacturing lot ofAPL-2 intravitreal investigational material. Inflammation in all affected patients resolved.
Based on its investigation, the Company believes that the likely source of inflammation resided in an impurity in the active pharmaceutical ingredient that was introduced during thescale-up of the manufacturing process to produce commercial lot sizes. The Company has modified its manufacturing process in order to eliminate the impurity and has manufactured sufficient supply ofAPL-2 utilizing the modified manufacturing process to conduct the entire Phase 3 GA program.
APL-2 intravitreal drug product produced from the modified manufacturing process was introduced into the Company’s ongoing Phase 1b trial in low vision patients with GA. Ten patients in the Phase 1b trial have received at least one intravitreal injection ofAPL-2 manufactured through the modified process, and there has been no inflammation observed in any patient injected with APL-2 from this new manufacturing lot. Patients in the Phase 1b trial will continue to receive monthlyAPL-2 injections for two years.
The independent safety monitoring committee reviewed allnon-clinical data and clinical data from the Phase 1b trial and agreed that the Company could resume dosing in the Phase 3 program usingAPL-2 manufactured with the modified process.
Forward-Looking Statements
Statements in this Form8-K about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the Company’s expectations regarding its Phase 3 clinical program for APL in patients with GA, including that the two Phase 3 GA trials will be fully enrolled by the end of the first quarter of 2020. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including; whether the Company’s clinical trials will be fully enrolled and completed when anticipated; whether preliminary or interim results from a clinical trial will be predictive of the final results of the trial; whether results obtained in preclinical studies and clinical trials will be indicative of results that will be generated in future clinical trials; and other factors discussed in the “Risk Factors” section of the Company’s Annual Report on Form10-K filed with the Securities and Exchange Commission on February 26, 2019 and the risks described in other filings that the Company may make with the Securities and Exchange Commission. Any forward-looking statements contained in this Form8-K speak only as of the date hereof, and the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
