RCS - Sareum Holdings PLC - Sareum notes FDA approval of first TYK2 Inhibitor

Sareum HoldingsAnnouncement

12/09/2022 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220912:nRSL0223Za&default-theme=true

RNS Number : 0223Z  Sareum Holdings PLC  12 September 2022

Sareum Holdings PLC

("Sareum" or the "Company")

Sareum notes the US FDA approval of Sotyktu™ (deucravacitinib), for
Moderate-to-Severe Plaque Psoriasis, the first TYK2 inhibitor to gain FDA
approval

 

Cambridge, UK, 12 September 2022 - Sareum Holdings plc (AIM: SAR), a clinical
stage biotechnology company developing next generation kinase inhibitors for
autoimmune disease and cancer, notes the announcement from Bristol Myers
Squibb (BMS) that the US Food and Drug Administration (FDA) has
approved Sotyktu™(deucravacitinib), a first-in-class, oral, selective,
allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults
with moderate-to-severe plaque psoriasis who are candidates for systemic
therapy or phototherapy.

This announcement supports Sareum's confidence in its broader portfolio of
TYK2/JAK1 inhibitors focused on autoimmune disease.

This is the first approval by the FDA of a medicine based on TYK2, a member of
the JAK cell signalling family. Sareum believes it provides clinical
validation for this class of therapeutic, and for the broader TYK2/JAK1
signalling family, which underpins Sareum's clinical portfolio.

The Company believes the TYK2/JAK1 signalling pathway which it is pursuing
offers potential for superior efficacy compared with agents, such as
deucravacitinib, which block just one of the two kinases.

The Sotyktu approval is based on a pivotal Phase 3 study of deucravacitinib
which demonstrated superior efficacy against placebo and standard of care. It
is also encouraging to note that deucravacitinib was well tolerated in the
Phase 3 study. Unlike some other medicines in the JAK inhibitor class, the FDA
is not requiring boxed warnings for deucravacitinib around the heightened risk
of serious heart-related events.

"We're encouraged that the FDA has approved Sotyktu (deucravacitinib)," said
Tim Mitchell, CEO of Sareum. "We believe this validates the potential of this
new therapeutic class and supports our own growing confidence around our lead
programme and our broader portfolio of TYK2/JAK1 inhibitors

"TYK2/JAK1 inhibition has demonstrated benefits in maintaining a healthy
immune system and has strong clinical validation in psoriasis and psoriatic
arthritis. Sareum has submitted a Clinical Trial Authorisation (CTA) to the
UK's Medicines and Healthcare Products Regulatory Agency to initiate a
clinical trial of SDC-1801, with an initial focus on psoriasis, and hopes to
begin dosing patients in 2023, subject to regulatory approvals."

Sareum will update on the regulatory progress of SDC-1801 in due course.

Bristol Myers Squibb's announcement can be found here
(https://news.bms.com/news/corporate-financial/2022/U.S.-Food-and-Drug-Administration-Approves-Sotyktu-deucravacitinib-Oral-Treatment-for-Adults-with-Moderate-to-Severe-Plaque-Psoriasis/default.aspx)
.

For further information, please contact:

 Sareum Holdings plc

 Tim Mitchell, CEO                                  01223 497700

 Strand Hanson Limited (Nominated Adviser)

 James Dance / James Bellman                        020 7409 3494

 Peel Hunt LLP (Joint Corporate Broker)

 James Steel                                        020 7418 8900

 Hybridan LLP (Joint Corporate Broker)

 Claire Noyce                                       020 3764 2341

 Consilium Strategic Communications (Financial PR)

 Jessica Hodgson / Davide Salvi/ Stella Lempidaki

 

About Sareum

Sareum Holdings (AIM:SAR) is a clinical stage biotechnology company developing
next generation kinase inhibitors for autoimmune disease and cancer.

The Company is focused on developing next generation small molecules which
modify the activity of the JAK kinase family and have best-in-class potential.
Its lead candidate, SDC 1801, simultaneously inhibits TYK2 and JAK1. SDC1801
is a potential treatment for a range of autoimmune diseases, which has entered
clinical development with an initial focus on psoriasis. Sareum is also
developing SDC1802, a TYK2/JAK1 inhibitor with a potential application for
cancer immunotherapy.

Sareum is also eligible to receive certain milestone payments and future
royalties on SRA737, a clinical-stage, oral, selective Checkpoint kinase 1
(Chk1) inhibitor that targets cancer cell replication and DNA damage repair
mechanisms. SRA737 is licensed to GSK, which acquired the previous licence
holder, Sierra Oncology, in June 2022

Sareum Holdings plc is based in Cambridge, UK, and is listed on the AIM market
of the London Stock Exchange, trading under the ticker SAR. For further
information, please visit the Company's website at www.sareum.com
(http://www.sareum.com/)

 

 

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

Reach is a non-regulatory news service. By using this service an issuer is confirming that the information contained within this announcement is of a non-regulatory nature. Reach announcements are identified with an orange label and the word “Reach” in the source column of the News Explorer pages of London Stock Exchange’s website so that they are distinguished from the RNS UK regulatory service. Other vendors subscribing for Reach press releases may use a different method to distinguish Reach announcements from UK regulatory news.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAGPUCCBUPPPUG