Zosano Pharma Corporation ZSAN

zsan announce RESULTS for qrypta & to file FOR NDA BY FEB 20

[Humanist]

Zosano Pharma Announces the Presentation of Multiple Positive Datasets from the Qtrypta™ Long-Term Safety Study at the Congress of the International Headache Society
September 09, 2019 08:30 ET | Source: Zosano Pharma Corporation
- Repeated Dosing of Qtrypta Over the Course of One Year Reaffirms Qtrypta is Effective and Well-Tolerated as an Acute Treatment for Migraine -
- Efficacy and Safety Profile Consistent in Sub Analyses of Patients Taking Concurrent Medications-

-Company is Preparing for a New Drug Application (NDA) Submission in Q4 2019-
FREMONT, Calif., Sept. 09, 2019 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced an oral presentation and two poster presentations of positive data from a one-year long-term safety study of Qtrypta™ for the acute treatment of migraine were presented at the 19th Congress of the International Headache Society (IHC) in Dublin, Ireland. The Qtrypta long-term safety study was an open-label trial evaluating the safety of a 3.8 mg dose of intracutaneous zolmitriptan in adults with migraine who had historically experienced at least 2 migraine attacks per month.
“With more than 6,000 migraine attacks treated in our clinical program, we have amassed a robust dataset on Qtrypta for the acute treatment of migraine, demonstrating its ability to consistently produce pain freedom and freedom from most bothersome symptoms,” said Dr. Don Kellerman, vice president of clinical development and medical affairs. “Additionally, with favorable safety data in patients treated with Qtrypta repeatedly for up to one year, we believe we have a compelling body of evidence that supports our NDA filing, which we expect in the fourth quarter of this year.”

An oral presentation by Stephanie Nahas, M.D., M.S.Ed., of Thomas Jefferson University reviewed an analysis of the approximately 6,000 attacks treated over one year with Qtrypta for the acute treatment of migraine. The administration of Qtrypta resulted in pain freedom for 44% of the attacks and freedom from patients’ most bothersome symptoms for 62% of the attacks at two hours, which is consistent with the positive clinical results seen in the Phase 2/3 pivotal study.

Data from safety assessments demonstrated that Qtrypta was well-tolerated throughout the 12 months of repeated use. The most common adverse events were redness and swelling at the application site of which more than 95% were classified as mild.  80% of these site reactions were gone within 48 hours. Patients treated with Qtrypta reported less triptan-like neurological side effects than are typically found with the class, with less than 2% of patients reporting effects such as dizziness and paresthesia.

Stephanie Nahas, M.D., M.S.Ed., Associate Professor of the Department of Neurology and Program Director of the headache medicine fellowship at Thomas Jefferson University, added, “These data provide optimism for persons with migraine. Achieving rapid relief from attacks while minimizing side effects is critically important. Those who don’t tolerate oral acute medication due to nausea, or who don’t benefit from it due to slow onset or gastric stasis, need alternative routes of administration. Intranasal and injectable formulations can work rapidly, but they may lead to more adverse events, and some patients dislike injecting themselves or spraying medication into their noses. Qtrypta offers a fast-acting well-tolerated alternative without compromising efficacy.”

Two late-breaking posters were also presented at the IHC congress. The first analyzed data from six patients enrolled in the long-term safety study who received prophylactic anti-CGRP antibodies and subsequently took Qtrypta for the acute treatment of their migraine attacks. Qtrypta was highly effective in relieving acute migraine symptoms with 76% achieving pain freedom and 88% reporting freedom from most bothersome symptoms at two hours. These preliminary data demonstrated that Qtrypta has the potential to be effective for the acute treatment of breakthrough migraine attacks in patients receiving prophylactic treatment with anti-CGRP antibody therapy.

The second poster presentation reviewed safety data from the 22 study participants who were on serotonergic drugs while taking Qtrypta for the acute treatment of migraine, and there were no reports of serotonin syndrome.

About Long-Term Safety Study
The open-label study evaluated the safety of 3.8 mg of intracutaneous zolmitriptan in adults with migraine who had historically experienced at least 2 migraine attacks per month. There were no maximum treatment limits. The primary outcome measure was long-term safety as measured by the incidence of adverse events over a 12-month period. Secondary outcome measures included efficacy measures such as pain freedom and freedom from most bothersome symptoms at two hours. The study evaluated over 342 adults with migraine at 31 sites in the U.S.
About Qtrypta™ (M207)
Qtrypta is Zosano’s proprietary formulation of zolmitriptan delivered utilizing its proprietary ADAM technology. Zosano's ADAM technology consists of titanium microneedles coated with drug, and in the case of Qtrypta, its formulation of zolmitriptan. The drug-coated microneedles penetrate into the epidermis and dermis, where the investigational drug is dissolved and enters into the bloodstream. In February 2017, the Company announced statistically significant results from the ZOTRIP pivotal study, in which the 3.8mg dose of Qtrypta met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours. In November 2017, the Company announced the initiation of its long-term safety study evaluating Qtrypta and expects to file an NDA for Qtrypta in the fourth quarter of 2019.

About Zosano Pharma
Zosano Pharma Corporation is a clinical stage biopharmaceutical company focused on developing products where rapid administration of established molecules with established safety and efficacy profiles may provide an increased benefit to patients, for markets where patients remain underserved by existing therapies. The company’s Adhesive Dermally-Applied Microarray (ADAM) technology consists of titanium microneedles coated with drug that is designed to enable rapid systemic administration of therapeutics to patients. Zosano’s lead product candidate is Qtrypta™ (M207), which is an investigational, proprietary formulation of zolmitriptan delivered via ADAM technology, currently in development for the acute treatment of migraine. In February 2017, the company announced positive clinical and statistically significant results from the ZOTRIP pivotal study and in February 2019, the company announced the completion of the final milestone in its long-term safety study. The company is preparing to submit a New Drug Application to the Food and Drug Administration for Qtrypta (M207). Learn more at www.zosanopharma.com.