ATYR PHARMA, INC. (NASDAQ:LIFE) Files An 8-K Other EventsItem 8.01Other Events
On October 5, 2017, aTyr Pharma, Inc. (the “Company”) presented a poster presentation at the 22nd International Annual Congress of the World Muscle Society (WMS) in Saint Malo, France, which provides further detail on the previously announced clinical data from the Company’s Phase 1b/2 Trial (003) in patients with early-onset facioscapulohumeral muscular dystrophy (FSHD).The poster is titled “Results of a Phase 1b/2 Study of ATYR1940 in Adolescents and Young Adults with Early-onset Facioscapulohumeral Muscular Dystrophy (FSHD) (ATYR1940-C-003),” and is filed as Exhibit 99.1 and incorporated herein by reference.
The poster presentation provides further detail on the previously announced results from the completed Phase 1b/2 open-label, intra-patient dose escalation 003 trial testing doses of Resolaris (ATYR1940) of up to 3.0 mg/kg weekly in patients with early-onset FSHD. In this study, Resolaris was generally well tolerated at doses up to 3.0 mg/kg once weekly in patients ages 16 to 20 years with early-onset FSHD.63% of patients (5 of 8) had increases from baseline in their Manual Muscle Test (MMT), a validated assessment tool that measures muscle strength, with a mean change from baseline of +3.8%. In addition, 67% of patients measured (4 of 6) had improvement in their Individualized Neuromuscular Quality of Life (INQoL) score, a validated patient reported outcome measuring a patient’s level of disease burden. On average, patients did not have a worsening of their disease burden as measured by INQoL. No signs of general immunosuppression were observed, and low-level ADA signals did not result in clinical symptoms.The Company believes these data are supportive of further advancement of Resolaris.
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Litigation Reform Act.Forward-looking statements are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. The Company intends these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and is making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements regarding the potential and potential therapeutic benefits of Resolaris™, the ability of the Company to successfully advance its pipeline or product candidates, undertake certain development activities (such as clinical trial enrollment and the conduct of clinical trials) and accomplish certain development goals and the timing of such activities and development goals, the timing of initiation of additional clinical trials and of reporting results from the Company’s clinical trials, the scope and strength of the Company’s intellectual property portfolio, the Company’s ability to receive regulatory approvals for, and commercialize, its product candidates and reflect the Company’s current views about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions the Company has made. Although the Company believes that its plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond the Company’s control including, without limitation, risks associated with the discovery, development and regulation of the Company’s product candidates, as well as those set forth in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2016 and in the Company’s other SEC filings. Except as required by law, the Company assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Item 9.01 Exhibits.
(d)Exhibits.
aTYR PHARMA INC ExhibitEX-99.1 2 life-ex991_6.htm EX-99.1 life-ex991_6.pptx.htm Results of a Phase 1b/2 Study of ATYR1940 in Adolescents and Young Adults With Early-onset Facioscapulohumeral Muscular Dystrophy (FSHD) (ATYR1940-C-003) Gennyne Walker1,…To view the full exhibit click here
About ATYR PHARMA, INC. (NASDAQ:LIFE)
aTyr Pharma, Inc. is a clinical-stage biotherapeutics company. The Company is engaged in the discovery and clinical development of medicines for patients suffering from severe, rare diseases using its Physiocrine biology, a discovered set of physiological modulators. The Company focuses on the development of Physiocrine-based therapeutics for the treatment of rare diseases, including facioscapulohumeral muscular dystrophy (FSHD) and limb-girdle muscular dystrophy (LGMD) 2B. The Company is developing Resolaris, an intravenous protein therapeutic for the treatment of rare myopathies with an immune component (RMICs). The Company is investigating Resolaris in patients with LGMD2B. The Company is conducting approximately three open label trials in patients with early onset FSHD, in adult patients with FSHD or LGMD2B and a long-term extension study in adult patients with FSHD. The Company has not generated any revenues.