Satsuma Provides Update, Prepares to Advance Lead Product Candidate, STS101

Satsuma Pharmaceuticals provided a corporate update, including recent progress with its development of STS101 for the acute treatment of migraine.

STS101 is a novel and proprietary investigational drug-device combination product specifically designed to enable intranasal administration of the anti-migraine drug, dihydroergotamine (DHE), with a PK profile optimized to provide consistent and robust clinical efficacy.

In a recently completed Phase 1 clinical trial, STS101 demonstrated a highly differentiated PK profile. The STS101 PK profile was characterized by rapid absorption, with clinically-relevant drug concentrations observed within ten minutes, sustained high drug exposure levels over time comparable to those achieved by intramuscular DHE injection, and low inter-subject variability. STS101 was well tolerated by clinical trial subjects, with all reported adverse events deemed mild and not clinically relevant. Importantly, no subjects administered STS101 experienced nausea or vomiting, which are common side effects of DHE when administered by injection. Satsuma plans to present results of the STS101 Phase 1 clinical trial at an upcoming medical meeting.

"We are excited to report that the intranasal administration of STS101 in our Phase 1 clinical trial achieved a PK profile that is favorable in comparison with other non-injectable DHE formulations, including liquid nasal spray and pulmonary-route orally inhaled products. The STS101 PK profile is well-suited to the treatment of acute migraine and predicts rapid and robust therapeutic effects that may be sustained for 24-48 hours following administration," Detlef Albrecht, M.D., Chief Medical Officer of Satsuma, said. "Completing the STS101 Phase 1 clinical trial brings us one step closer to achieving our goal: making the long-recognized and differentiated therapeutic benefits of DHE broadly available to migraine sufferers in a compact, simple-to-use, self-administered, and non-injectable product."

Satsuma also announced the successful completion of a meeting with the U.S. Food and Drug Administration (FDA). In consultation with the FDA, the Company has established key elements of the Phase 3 development program to support a New Drug Application (NDA) for STS101 for the acute treatment of migraine.

Satsuma plans to initiate a randomized, double-blind, placebo-controlled Phase 3 clinical trial in the third quarter of 2019 to evaluate the efficacy and safety of STS101 as an acute treatment for migraine.

In addition to providing an update on STS101 development, Satsuma also announced that Tom O'Neil has joined the Company as its Chief Financial Officer. He joined the Company from Protagonist Therapeutics, where he served as Chief Financial Officer since early 2016.

"Tom brings to Satsuma a wealth of relevant finance and operations experience within the biopharmaceutical industry, including leading successful initial public offering and private equity transaction initiatives, and we will benefit from his knowledge and experience as we continue to build the Company," John Kollins, President and Chief Executive Officer of Satsuma, said.

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