RCS - IP Group PLC - Istesso announces FDA Fast Track for MBS2320

IPAnnouncement

05/12/2022 07:00

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RNS Number : 5197I  IP Group PLC  05 December 2022

 FOR RELEASE ON  05 December 2022

 

IP Group plc - Portfolio company Istesso announces FDA Fast Track and Orphan
Drug designation for MBS2320

 

IP Group plc (LSE: IPO) ("IP Group" or "the Group"), which develops
world-changing science and technology businesses across life sciences,
technology and cleantech, notes that portfolio company Istesso Ltd ("Istesso"
or "the Company"), the immunometabolism drug discovery and development
company, has announced that the U.S. Food and Drug Administration (FDA) has
granted Fast Track designation for Istesso's investigational metabolic
reprogramming agent, MBS2320, for the treatment of patients with idiopathic
pulmonary fibrosis (IPF).

The fast track
(https://eur02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fpatients%2Ffast-track-breakthrough-therapy-accelerated-approval-priority-review%2Ffast-track&data=05%7C01%7Cliz.vadams%40ipgroupplc.com%7C6a4c78cacc804c0257cd08dad4629ac3%7C2e5a66b71d8147c08ba59425dd864acf%7C0%7C0%7C638055817214461662%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=GhTynKjPAV5Leg2IjlidxdONgnO4MQCk4xxwHl6xc6Y%3D&reserved=0)
 process is designed to facilitate the development and expedite the review of
drugs to treat serious conditions and fill an unmet medical need. The purpose
is to get important new drugs to the patient earlier. A fast  track drug must
show some advantages over available therapy, such as the potential for
superior effectiveness or an improved effect on serious outcomes.

MBS2320 is a first-in-class investigational drug which is currently in
clinical development for the treatment of rheumatoid arthritis (RA) where it
has demonstrated a unique profile, reducing inflammation and supporting the
remodelling of damaged bone. In models of IPF, MBS2320 has shown a similarly
unique profile, reducing symptoms of IPF while also supporting remodelling of
fibrotic tissue. A clinical study in patients with IPF will start in 2023.

The FDA has also designated MBS2320 an orphan drug for the treatment of IPF.
This designation makes Istesso eligible for development incentives, including
tax credits, FDA assistance with clinical trial costs, and seven years of
market exclusivity in the U.S., should the treatment gain market approval.

Dr Lisa Patel, CEO and co-founder of Istesso, comments: "This fast track
designation reflects the pressing need for new treatments to help patients
with IPF. At Istesso we are committed to creating genuine improvements in
patients' health and quality of life. This fast-track designation is an
important milestone that will help us advance MBS2320 to patients with this
debilitating and life-threatening condition more rapidly".

IP Group has an undiluted holding of 56% in Istesso.

For more information, please contact:

 

 IP Group plc                                             www.ipgroupplc.com (http://www.ipgroupplc.com)
 Liz Vaughan-Adams, Communications                        +44 (0) 20 7444 0062/+44 (0) 7967 312125
 Charlotte Street Partners
 David Gaffney                                            +44 (0) 7854 609998
 Andrew Wilson                                            +44 (0) 7810 636995

 

Notes for editors

 

About IP Group

 

IP Group develops world-changing science and technology businesses across
life sciences, technology and cleantech (through Kiko Ventures). The Group has
a strong track record of success, having been the founder investor in a number
of high-profile companies including Oxford Nanopore Technologies plc, and has
one of the most exciting portfolios of high-growth businesses in Europe. The
Group also owns Parkwalk, the UK's largest growth EIS fund manager which backs
world-changing technologies emerging from the UK's leading universities and
research institutions. IP Group is listed on the Main Market of the London
Stock Exchange under the code IPO.

 

For more information, please visit our website at www.ipgroupplc.com
(http://www.ipgroupplc.com/) .

 

About Istesso

 

Istesso is a clinical-stage biopharmaceutical company, developing novel drug
candidates which reprogramme immune cell metabolism to treat autoimmune and
inflammatory conditions. Istesso's products have applications in conditions
such as Rheumatoid Arthritis, Idiopathic Pulmonary Fibrosis and Cancer.

 

About MBS2320

 

MBS2320 is an investigational, first-in-class metabolic reprogramming agent.
Its unique dual mode of action, reducing inflammation and fibrosis and
supporting the remodelling of tissue damage gives MBS2320 the potential to
both control the disease symptoms and resolve the underlying pathology across
multiple disease indications including IPF, RA and other autoimmune
diseases.

 

About IdioPathic Pulmonary Fibrosis

 

IPF is a progressive, life‑threatening disease characterized by scarring of
the lungs. This leads to debilitating symptoms including shortness of breath
and difficulty performing routine functions, such as walking and talking. In
the U.S., ~21,000 people are diagnosed with IPF per year. There remains a
significant and urgent unmet need for improved treatment options; patients
with IPF have an average life expectancy of approximately three to five years
from diagnosis and approximately two-thirds of patients die within five years,
a mortality rate comparable to some of the deadliest cancers.

 

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