Clinical-stage biopharmaceutical firm Satsuma Pharmaceuticals Inc. (STSA:NASDAQ), which is focused on finding novel treatments for migraine and other debilitating conditions, today announced "positive safety, tolerability and efficacy results from its recent analysis of the company's ongoing STS101 ASCEND Phase 3 open-label, long-term safety trial."
The company advised that STS101 (dihydroergotamine) is a nasal powder that is being developed for the treatment of acute migraine. STS101 is designed to be self-administered using a proprietary easy-to-use nasal delivery device.
The firm indicated that the primary goal of the Phase 3 ASCEND study is to assess STS101's safety and tolerability over six- and 12-month periods. The company listed that a secondary objective in the trial was to evaluate STS101's efficacy in the acute treatment of migraine attacks over time.
Satsuma Pharmaceuticals stated that it plans to utilize this latest safety data along with results from its ongoing Phase 3 SUMMIT efficacy trial when those results are released in Q4/22 to provide the basis for submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) during Q1/23.
The company said, "it intends to seek marketing approval for and, if approved, commercialize STS101Mk2, which incorporates the improved, second-generation nasal delivery device."
Satsuma Pharmaceuticals' President and CEO John Kollins commented, "The results reported today from this open-label, long-term safety trial in which subjects administered STS101 to treat their migraine attacks for as long as 18 months in a real-world setting confirm the favorable safety and tolerability profile of STS101 observed to date in more than 1,600 clinical trial participants and provide important safety information for our planned NDA submission."
Kollins continued, "The efficacy signals observed with STS101Mk2, including the robust reported rates for freedom-from-pain and freedom-from-MBS by two hours post-treatment, are consistent with its demonstrated improved drug delivery performance as compared to STS101Mk1, which incorporated a first-generation nasal delivery device."
Alan M. Rapoport, M.D., Professor of Neurology at UCLA, remarked, "New and effective evidence-based treatments for migraine are urgently needed, especially for the many people with migraine for whom other treatment options, including triptans and gepants, are slow to work, provide insufficient relief or are not well-tolerated … The totality of data generated to date with STS101 points to its potential to transform the paradigm for the acute treatment of migraine attacks."
The firm mentioned that the Phase 3 ASCEND trial commenced in August 2020. The study enrolled a total of 480 people, 466 of whom self-administered one or more doses of STS101Mk1 or STS101Mk2 study medication.
The company noted that STS101 has demonstrated a favorable safety and tolerability profile in both Phase 1 and Phase 3 clinical studies.
The firm explained that it transitioned from STS101Mk1 to STS101Mk2 in the study in H1/21 after having provided over 10,000 doses of STS101 for the treatment of more than 8,000 migraine attacks.
The firm stated that to date, 344 patient subjects had self-administered a total of more than 6,900 doses of STS101Mk2 to treat their migraine attacks as needed for a period of around 18 months.
According to Satsuma, data from those participants showed no clinically relevant nasal safety or tolerability findings, and no serious adverse events were reported.
The company mentioned that 166 subjects with an average of at least two migraine attacks per month were treated with STS101Mk2 over a period of at least six months. The firm comments that the number of individuals evaluated exceeds the FDA's 150-subject threshold, which is a requirement for NDA filing and potential marketing approval.
The firm listed that 172 subjects in its study in aggregate treated 1,932 migraine attacks exclusively with STS101Mk2. The results showed that "freedom from pain by two hours post-treatment (2hPF response) was achieved in 34.2% of all treated attacks," and "freedom from most-bothersome-symptom by two hours post-treatment (2hMBS response) was achieved in 53.4% of all treated attacks."
Satsuma is a clinical-stage biopharmaceutical firm based in South San Francisco, Calif. The company is engaged primarily in the development of novel treatments for migraine and other debilitating conditions ad diseases.
The company lists on its website that "it has collectively contributed to the development, manufacturing, and/or commercialization of more than 50 approved drug products, including 15 approved drug-device combination products, 13 of which are delivered via inhalation."
Satsuma Pharmaceuticals started the day with a market cap of around $219.53 million with approximately 31.59 million shares outstanding. STSA shares opened unchanged today at $6.95 (+$0.00, +0.00%) from yesterday's $6.95 closing price and then proceed to rise to a new 52-week high price this morning of $7.98. The stock has traded today between $6.67 and $7.98 per share and is currently trading at $7.79 (+$0.84, +12.09%).
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