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Topline-data from Phase 1/2 clinical trial of KB103 (bercolagene telserpavec) for treatment dystrophic epidermolysis bullosa (DEB) to be announced in 1H 2019
Ancoris, a cGMP facility for clinical and commercial production of KB103, is operational following successful completion of a trial run.
Planned filing of an IND for KB105 to treat autosomal recessive congenital ichthyosis (ARCI) in 1H 2019
Company was granted second patent for compositions containing KB103, formulated for alternate routes of administration
PITTSBURGH, March 12, 2019 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), a gene therapy company developing medicines to treat dermatological diseases announced financial results for 2018 and an update on its business progress.
Commenting on the year, Krish S. Krishnan, chairman and chief executive officer, said, “2018 was a productive year for Krystal as we worked to become fully-integrated in the gene therapy space. On the clinical front, we announced positive interim results on two adult patients from the placebo-controlled GEM-1 study of KB103 in October, and the completion of dosing of the remaining four, adult and pediatric patients in the study in December. On the manufacturing front, we recently inaugurated the Ancoris cGMP facility following a successful trial run, for the exclusive clinical and potential commercial production of KB103. On the platform front, we have started to demonstrate the viability of our platform beyond rare skin diseases as we expand into broad skin diseases and aesthetic skin conditions."
Mr. Krishnan continued, “Our top four priorities in 2019 are to commence the pivotal study of KB103 following completion of the Phase 1/2 GEM-1 study, initiate a Phase 1/2 clinical study of our second rare disease therapy, KB105, file an IND on an additional pipeline product, yet to be disclosed and begin work on our second, larger cGMP facility in Pittsburgh, to fully serve the production needs of our pipeline products."
2018 and Recent Corporate Highlights
Financial results for the year ended December 31, 2018
For additional information on the Company’s financial results for the year ended December 31, 2018, refer to form 10K filed with the SEC.
About Krystal Biotech
Krystal Biotech, Inc. (NASDAQ:KRYS) is a gene therapy company dedicated to developing and commercializing novel treatments for patients suffering from dermatological diseases. For more information, please visit http://www.krystalbio.com.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding our intention to commence a pivotal study of KB103 in 2019, our ability to manufacture all needed clinical trial quantities of KB103 in our Ancoris manufacturing facility and to begin work on a second, larger manufacturing facility, our plans to file an IND for KB105 in the first half of 2019 and to file a second IND for an additional pipeline product in 2019,. You can identify forward-looking statements because they contain words such as “believes” and “expects.” Forward-looking statements are based on Krystal’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees nor assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Krystal’s filings with the Securities and Exchange Commission, including its registration statement on Form S-1 and Form 10-K, as amended from time to time, under the caption “Risk Factors.”
Ashley R. Robinson
Darren Opland, PhD
LifeSci Public Relations
Source: Krystal Biotech, Inc.