Satsuma Pharmaceuticals lagged behind in a phase 3 study testing the treatment of migraine headaches. Failure of the clinical trial is likely to end the program and the company. Instead, Satsuma now has a new plan that has convinced investors to raise $ 80 million to give migraine treatment another chance.
Later this month, San Francisco-based Satsuma plans to start a phase 1 study to evaluate three different dose strengths of his migraine treatment. The company expects to include the selected dose in a new phase 3 study by the middle of the year.
Satsusma is developing a drug / device combination product, STS101, that delivers a dry powder formulation of dihydroergotamine mesylate (DHE). The drug is an ancient drug that has been used to treat acute migraine headaches for decades. However, the company contends that nasal spray and injectable DHE formulations currently available are insufficient. Satsuma designed their device to give patients an easy-to-administer option that also provides faster relief.
Last September, preliminary results from a Phase 3 study in more than 1,140 patients showed that those who received DHE via STS101 showed improvements in pain scores. However, this improvement was insufficient to show statistical significance compared to the placebo group. The failure of the clinical trial wiped out nearly 80% of the value of Satsuma shares.
Satsuma now has an explanation for why STS101 fell short: The self-administered device did not deliver the full dose of DHE. Speaking on a conference call on March 1, John Kollins, President and CEO of Satsuma, said the delivery of the drug was due in part to a problem in the design of the device and human error that was not taken into account in previous developments and tests of the device.
The Satsuma device was designed to be easy to use. The nozzle is inserted into a nostril and the drug is administered by squeezing a small plunger that contains the powder formulation of DHE. However, analysis of the devices after the trial showed that the patients only delivered about 70% of the dose. Kollins said the patients pressed the lightbulb too slowly and the full dose was not given. This problem could not be resolved by a second press as the first pulled the force behind the nozzle and made it unavailable.
In the future, Satsuma will train staff and patients on-site in the clinical trial to use the device. Kollins said patients will also practice self-administration with the device so they can familiarize themselves with using it before they have a migraine attack. He added that the company made “minor improvements” to the device, including a thinner lightbulb that is easier to squeeze and a check valve that prevents loss of the powder.
Satsuma is making additional changes to provide a better outcome for clinical trials. In the failed phase 3 study, two doses were tested: 5.2 mg and 3.9 mg. In the planned Phase 1 study, the 5.2 mg dose will be evaluated along with two higher dose strengths to determine whether the higher doses work better. The best one of the three doses is advanced to phase 3 testing. Kollins said Satsuma came up with his new plan after speaking with migraine experts.
“We have a long expected product life with STS101, given the combination of drugs and devices in the product and the long patent lifespan we currently have through 2039,” said Kollins. “So we believe we can have branded product pricing for a long time.”
Satsuma expects preliminary data from the new Phase 3 study to be available in the second half of next year. If the read is positive, the company believes it can reapply for FDA approval in the fourth quarter of 2022. According to this schedule, Impel Neuropharma is in Seattle, which has developed its own technology for the intranasal delivery of DHE. The company has already submitted its drug and device combination product candidate for review by the FDA. An official decision is expected in September this year.
Satsuma’s $ 80 million private placement was led by Commodore Capital and New Enterprise Associates. Other investors include RA Capital, Vivo Capital, Samlyn Capital, Surveyor Capital, Aspire Capital Fund, funds managed by the Ghost Tree Capital Group, Point72 Asset Management and Logos Capital. Shin Nippon Biomedical Laboratories, co-founder of Satsuma, also invested.
Kollins said Satsuma’s cash holdings combined with the new capital should support the company well into the second half of 2023.
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