Zosano Pharma Presents Early-Onset of Action Data for Qtrypta™ in Acute Treatment of Migraines

Rhea-AI Summary

Zosano Pharma Corporation (NASDAQ:ZSAN) announced promising data from the ZOTRIP trial for its investigational therapy Qtrypta™ aimed at acute migraine treatment, presented at the Annual Headache Cooperative of the Pacific Winter Conference. Analysis indicated significant therapeutic gain at 30 minutes. Specifically, 74% of patients who were pain-free at 30 minutes remained pain-free at 2 hours, compared to 35% in the placebo group. Qtrypta utilizes a novel microneedle system for rapid drug delivery, which is crucial for patients unable to tolerate oral medications.

Positive

• 74% of patients treated with Qtrypta were pain-free at 2 hours compared to 35% in the placebo group.
• Qtrypta shows potential as a rapid and effective alternative for migraine treatment.
• Therapeutic gain observed at 30 minutes indicates strong early pain relief capabilities.

Negative

• None.

• Review of data from the ZOTRIP trial suggest that Qtrypta showed therapeutic gain at 30 minutes consistent with recently published criteria for evaluating early onset of action
  
  
• All Qtrypta patients who were pain free at 30 minutes were still pain free at 2 hours
  
  
• Observation of pain freedom at 30 minutes was more accurate than the observation of relief at 30 minutes in predicting pain freedom at 2 hours
  

FREMONT, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that early onset of action data for Qtrypta™, Zosano’s investigational therapy for the acute treatment of migraine formulated utilizing its microneedle system, were presented at the Annual Headache Cooperative of the Pacific Winter Conference.

“We believe Qtrypta shows tremendous potential to become an attractive therapeutic alternative to acutely treat migraines,” said Steven Lo, President and CEO of Zosano. “As our lead program utilizing our novel microneedle patch technology designed to deliver drug through the skin, Qtrypta has demonstrated rapid pain relief in patients who are often too nauseated to take oral medications which take time to travel to the gastrointestinal tract before providing pain relief.”

In a post-hoc retrospective analyses of data from the previously published ZOTRIP trial involving 365 subjects who received Qtrypta 3.8 mg or placebo, of 82 Qtrypta-treated subjects, 38 reported pain relief at 30 minutes, and 28 of the 38 subjects (74%) were pain free at two hours. All 6 subjects treated with Qtrypta who reported pain freedom at 30 minutes were pain-free at two hours. This compares to nine of 26 subjects (35%) in the placebo group (n=77) who reported pain relief at 30 minutes that were pain free at 2 hours, and 1 of 2 subjects that were pain free at 30 minutes being pain free at 2 hours.

These data describe therapeutic gain at 30 minutes, a measure consistent with recently published criteria for evaluating early onset of action published in Cephalalgia, an International Journal of Headache, by Pfelt-Hansen and Diener. The post-hoc analysis of data from the ZOTRIP trial suggests that the therapeutic gain for pain freedom, instead of pain relief, may be a more reliable endpoint for evaluating early onset of action.

“Qtrypta demonstrated rapid and robust improvement in the rates of pain relief and pain freedom in two hours. I believe that rapid onset of meaningful and sustained improvement is of utmost importance to patients suffering from migraines,” said Dr. Deborah Friedman, Professor of Neurology and Ophthalmology at the University of Texas Southwestern Medical Center.

About Qtrypta™ (M207)
Qtrypta is Zosano’s proprietary investigational formulation of zolmitriptan delivered utilizing its proprietary transdermal microneedle system (the “System”) in development for the acute treatment of migraine. The System consists of titanium microneedles coated with drug, and in the case of Qtrypta™, the formulation is zolmitriptan. The drug-coated microneedles are designed to penetrate the stratum corneum, where the investigational drug potentially dissolves and easily enters into the bloodstream. In February 2017, the company announced statistically significant results from the ZOTRIP pivotal study, in which the 3.8 mg dose of Qtrypta™ met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours.

About Migraine
Migraine is a highly prevalent neurological disease impacting 12% of the US population and 1 in 4 households. Patients impacted by migraine experience significant disability, with 90% unable to function normally.  Migraine attacks are estimated to lead to lost productivity costs as high as $36 billion annually in the United States, including both direct and indirect costs. Zosano believes there is a significant need for new acute treatment options since 74% of migraine patients experience inadequate treatment response.

About Zosano Pharma
Zosano Pharma Corporation is a clinical-stage biopharmaceutical company focused on developing products where rapid administration of approved molecules with established safety and efficacy profiles may provide substantial benefit to patients, in markets where patients remain underserved by existing therapies. The company’s transdermal microneedle system technology consists of titanium microneedles coated with drug that are designed to enable rapid systemic administration of therapeutics to patients. Zosano’s lead product candidate is Qtrypta™ (M207), which is a proprietary formulation of zolmitriptan designed to be delivered via its transdermal microneedle system technology, as an acute treatment for migraine. Learn more at www.zosanopharma.com.

Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the potential benefits of Qtrypta for patients and other future events and expectations described in this press release. Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict, and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the company’s ability to obtain additional cash resources to continue operations, the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K and quarterly reports on Form 10-Q. Although Zosano believes that the expectations reflected in these forward-looking statements are reasonable, Zosano cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.

Zosano Contacts:
Christine Matthews
Chief Financial Officer
510-745-1200

Zosano PR:
Sylvia Wheeler or Alexandra Santos
swheeler@wheelhouselsa.com or asantos@wheelhouselsa.com 

FAQ

What are the key findings from the ZOTRIP trial for ZSAN's Qtrypta?

The ZOTRIP trial data indicate that 74% of patients treated with Qtrypta were pain-free at 2 hours after achieving pain freedom at 30 minutes, demonstrating significant therapeutic gain.

How does Qtrypta compare to placebo in migraine relief?

In the ZOTRIP trial, 74% of Qtrypta-treated patients who reported pain relief at 30 minutes remained pain-free at 2 hours, compared to only 35% in the placebo group.

What is the significance of the 30-minute observation in the ZSAN press release?

The 30-minute observation is significant as it was a more reliable predictor of pain freedom at 2 hours, highlighting Qtrypta's rapid onset of action.

What technology does Qtrypta utilize for migraine treatment?

Qtrypta utilizes a novel transdermal microneedle system designed for rapid drug delivery through the skin.

When was the ZOTRIP trial data presented by Zosano Pharma?

The data from the ZOTRIP trial for Qtrypta was presented at the Annual Headache Cooperative of the Pacific Winter Conference on February 1, 2021.