HIMUKA AM AUSTRALIA ANNOUNCES COMPLETION OF
PHASE 1 CLINICAL TRIAL OF HM201 IN AUSTRALIA
04 APRIL 2023
Himuka AM Australia Pty Ltd. today announced that a Phase 1 clinical trial of
HM201, a novel adrenomedullin based peptide drug candidate developed for thetreatment of Inflammatory bowel disease (IBD), has been completed. The
preliminary results of this study demonstrated excellent data with final results
scheduled to be reported in several months.
"The trial was affected by the COVID-19 pandemic and the severe flooding inBrisbane, although we overcame the difficulties with the cooperation of thesubjects, the clinical site and the CRO. We are proud to have been able to submita Clinical Trial Notification of study completion to the Therapeutic Goods
Administration," said Hiroshi Shinjo, Chief Executive Officer of Himuka AM
Australia.
The Phase 1 clinical trial of HM201 was a double-blind, placebo-controlled,ascending dose, multi-cohort study in healthy subjects consisting of single
ascending dose and multiple ascending dose cohorts. The study aimed to assess
the safety, tolerability, and pharmacokinetics of single and multiple intravenous
administrations of HM201.
(ClinicalTrials.gov Identifier: NCT05088369)

About HM201
HM201 is a novel peptide drug candidate created by improving the bioactive
peptide adrenomedullin.
Adrenomedullin contributes to the regulation of homeostasis in the human bodythrough the action of regeneration of epithelial and endothelial cells,angiogenesis, and anti-inflammation. In the Phase 2a clinical trial of1

adrenomedullin for steroid-resistant ulcerative colitis (UC) conducted by
University of Miyazaki, Japan, they observed the complete remission at 8 weeks
in patients with steroid-resistant UC receiving a certain dose of adrenomedullin.
Himuka believes that HM201 may have the same pharmacological effects asadrenomedullin and is developing HM201 with the belief that it may contributeto the healing of the intestinal mucosa in suffering patients.
About Himuka
Himuka AM Australia Pty Ltd. is an Australian company which was established by
Himuka AM Pharma Corp. for the development of HM201 in Australia.
Himuka AM Pharma Corp. is a multi-asset clinical-stage biopharmaceuticalcompany focused on developing novel treatments in areas of unmet needincluding refractory Inflammatory bowel disease.
Regarding Himuka's first candidate, adrenomedullin (HM101), several Phase 2a
investigator-initiated clinical trials have been conducted under programs of theJapan Agency for Medical Research and Development.
Himuka is also advancing HM201, its novel peptide drug candidate for thetreatment of diseases through the improvement of the barrier function ofepithelial or endothelial cells, and the function of angiogenesis.
For more information, visit https://www.himuka-am.com/
Forward-Looking Statements
This press release may contain forward-looking statements.
Statements contained in this press release concerning plans, predictions, andstrategies to improve future performance (“Forward-Looking Statements”) arebased on information currently available to Himuka's management, andinevitably involve a certain element of risk and uncertainties.
Actual results may therefore differ from those in the Forward-Looking Statements.
Therefore, forward-looking statements should not be relied upon as representing
Himuka's views as of any date after the date of this press release.

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