PureTech Provides End of Year Report on Key Progress Across Wholly Owned Programs and Founded Entities
December 16 2021 - 1:00AM
Business Wire
Three clinical-stage, wholly-owned candidates
being advanced across range of indications, including two Phase 2
trials of LYT-100 (deupirfenidone), a Phase 1/2 trial of LYT-200
(anti-galectin-9 mAb) and a Phase 1 study of LYT-300 (oral
allopregnanolone)
Key milestones achieved across Founded Entities
position them for value inflection, including manufacturing scale
up and commercial launch and launch preparations for Gelesis’
Plenity® and Akili’s EndeavorRx®, respectively, as well as multiple
positive clinical results across Founded Entities
Continued validation of four lymphatic and
inflammation platforms, including advancement of therapeutic
candidates from these platforms and the achievement of preclinical
proof-of-concept data for Orasome™
Catalyst-rich 2022 anticipated, with results
from multiple studies and further growth and advancement of
therapeutics, which have the potential to impact serious diseases
with limited treatment options
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the
“Company”), a clinical-stage biotherapeutics company dedicated to
discovering, developing and commercializing highly differentiated
medicines for devastating diseases, today reported on the key
progress made across its Wholly Owned Programs1 and Founded
Entities2 in 2021, including some updates that were not previously
reported.
Daphne Zohar, Founder and Chief Executive Officer of PureTech,
commented: “2021 has been a year of profound achievements and
fundamental growth across our Wholly Owned Programs and our Founded
Entities. With the support of our shareholders, we have pioneered a
unique R&D model that has been successful in identifying,
inventing and advancing novel therapeutic candidates for serious
diseases and creating wholly-owned programs as well as both public
and private Founded Entities with substantial value. We are proud
of our execution and successes and are excited about using that
strong foundation to catalyze value as we enter into an important,
milestone-rich 2022, having the benefit of a strong balance sheet
from which to drive value.”
PureTech’s Wholly Owned Programs are comprised of six
therapeutic candidates and four lymphatic and inflammation
platforms. Additionally, PureTech’s Founded Entities are advancing
19 therapeutics and therapeutic candidates, of which two have been
cleared for marketing by the U.S. Food and Drug Administration
(FDA) and granted marketing authorization in the European Economic
Area, and 14 are clinical stage. Key highlights include the
following:
Wholly Owned Programs
- LYT-100 (deupirfenidone), in development for potential
treatment of conditions involving inflammation and fibrosis:
- Progressed Phase 2 clinical trial in patients with Long COVID
respiratory complications. Enrollment is expected to be completed
by the end of 2021, with topline results anticipated in the first
half of 2022.
- Progressed Phase 2a clinical trial in patients with breast
cancer-related, upper limb secondary lymphedema. Results are
anticipated in 2022.
- Presented the results of the Phase 1 multiple ascending dose
and food effect study of LYT-100 at the virtual European
Respiratory Society (ERS) International Congress. The results from
the study were subsequently published in the journal Clinical
Pharmacology in Drug Development.
- PureTech plans to provide further details around its
development plans for LYT-100 in additional inflammatory and
fibrotic conditions, such as idiopathic pulmonary fibrosis,
myocardial fibrosis and other organ system fibrosis.
- LYT-200 (anti-galectin-9 mAb) & LYT-210
(anti-gamma delta-1 mAb), in development for the potential
treatment of a range of cancer indications:
- LYT-200 was granted orphan drug designation by the U.S. FDA for
the treatment of pancreatic cancer.
- Progressed Phase 1/2 trial of LYT-200 for the potential
treatment of a range of solid tumors. Results from the Phase 1
portion are anticipated in the first half of 2022.
- Entered into a clinical trial and supply agreement with BeiGene
to evaluate LYT-200 in combination with tislelizumab in solid
tumors.
- Presented new research at the American Association for Cancer
Research (AACR) Annual Meeting demonstrating that LYT-210 is both
highly specific and highly potent, rapidly inducing cell death of
immune-suppressive γδ1 T cells, while sparing other T cells that
play important roles in a healthy immune response. The research was
conducted using both patient blood and cancer tissue.
- LYT-300 (oral allopregnanolone), in development for the
potential treatment of neurological and neuropsychological
conditions, & Glyph™ Technology Platform:
- Initiated a Phase 1 clinical study in healthy volunteers to
evaluate safety, tolerability, and pharmacokinetic profile, as well
as explore the impact of LYT-300 on b-EEG, a marker of GABAA target
engagement, thus potentially providing early insights into the
mechanistic effects of LYT-300. Results from the study will inform
the design of possible future studies in indications that could
include depression, anxiety, sleep disorders, fragile X
tremor-associated syndrome, essential tremor and epileptic
disorders, among others.
- Presented preclinical proof-of-concept data at the American
College of Neuropsychopharmacology (ACNP) Annual Meeting showing
that systemic exposure of natural allopregnanolone was achieved
after oral administration of LYT-300 in multiple preclinical animal
models.
- Published preclinical proof-of-concept work in Nature
Metabolism and the Journal of Controlled Release supporting the
Glyph technology platform’s ability to directly target the
lymphatic system with a variety of therapies.
- LYT-500 (oral IL-22 + anti-inflammatory), in development
for the potential treatment of inflammatory bowel disease,
LYT-503 (partnered non-opioid pain program), in development
for the potential treatment of interstitial cystitis/bladder pain
syndrome, & Alivio™ Technology Platform:
- Declared LYT-500 therapeutic candidate. Progressed preclinical
proof-of-concept work.
- Advancing LYT-503 as a potential targeted non-opioid treatment
for interstitial cystitis or bladder pain syndrome in collaboration
with a partner, following the exercise of a license option under an
existing research and development collaboration. An Investigational
New Drug Application is planned to be filed in 2022.
- Evaluating other potential therapeutic candidates leveraging
Alivio technology platform for Wholly Owned Pipeline
expansion.
- Orasome Technology Platform:
- Established preclinical proof-of-concept supporting the
platform’s potential to achieve therapeutic levels of proteins in
circulation following the oral administration of therapeutic
protein expression systems. PureTech intends to generate additional
preclinical data in 2022. Using the Orasome technology platform, it
may be possible for a patient to take an oral drug product that
will permit their own gastrointestinal tract cells to make
virtually any type of therapeutic protein. This approach also has
the potential to provide a more convenient and significantly less
expensive means to administer biological medicines.
- Meningeal Lymphatics Program:
- Published preclinical research in Nature suggesting that
restoring lymphatic flow in the brain has the potential to address
a range of neurodegenerative diseases, such as Alzheimer's and
Parkinson's diseases and associated neuroinflammation. The work
also uncovered a link between dysfunctional meningeal lymphatics
and damaging microglia activation in Alzheimer's disease,
suggesting another route by which restoring healthy drainage
patterns could improve clinical outcomes.
Founded Entities:
- Gelesis
- Broadly launching Plenity®, an FDA-cleared weight management
approach, in the U.S. to adults who meet the prescription criteria.
Gelesis’ first commercial-scale manufacturing line at the facility
is also now complete and validated.
- Achieved both primary endpoints in LIGHT-UP study of GS200 in
adults with overweight or obesity who also have prediabetes or type
2 diabetes. Gelesis continues to analyze these data as it plans its
next steps in the development of GS200 and plans to present the
detailed results in a scientific venue.
- Initiated Phase 2 study of GS300, which is in development for
the potential treatment of nonalcoholic fatty liver
disease/non-alcoholic steatohepatitis (NAFLD/NASH).
- Entered into definitive business combination agreement with
Capstar Special Purpose Acquisition Corp. Upon completion of the
transaction, the combined company’s securities are expected to be
traded on the New York Stock Exchange (NYSE) under the symbol
“GLS”.
- Akili
- Completed a $160 million financing, a new licensing agreement
with Australian digital health company, TALi®, and new gaming
features and functionalities for EndeavorRx®.
- Initiated Phase 2 study of AKL-T01 for COVID brain fog in
collaboration with Weill Cornell and Vanderbilt.
- Published full data in Nature Digital Medicine from STARS
Adjunct study, which evaluated impact of EndeavorRx (AKL-T01) on
symptoms and functional impairments in children with
attention-deficit/hyperactivity disorder (ADHD).
- Announced results from Shionogi’s Phase 2 study of SDT-001
(Japanese version of AKL-T01) that showed treatment was
well-received by patients and demonstrated improvements in ADHD
inattention symptoms consistent with those seen across previous
studies of AKL-T01.
- Karuna
- Announced all four Phase 3 trials in the EMERGENT program, the
clinical program evaluating KarXT (xanomeline-trospium) for the
treatment of psychosis in adults with schizophrenia, are enrolling.
Karuna anticipates reporting topline data from the Phase 3
EMERGENT-2 trial in mid-2022 and from the Phase 3 EMERGENT-3 trial
in the second half of 2022.
- Initiated the Phase 3 ARISE trial evaluating KarXT for the
treatment of schizophrenia in adults who experience an inadequate
response to current standard of care.
- Reported data from completed Phase 1b trial evaluating safety
and tolerability of KarXT in healthy elderly volunteers. Karuna
plans to initiate a Phase 3 program evaluating KarXT for the
treatment of psychosis in Alzheimer’s disease in mid-2022.
- Published results from the Phase 2 EMERGENT-1 clinical trial
evaluating KarXT for the treatment of schizophrenia in the New
England Journal of Medicine (NEJM).
- Announced entry into an exclusive license agreement with Zai
Lab for the development, manufacturing and commercialization of
KarXT in Greater China, including mainland China, Hong Kong, Macau,
and Taiwan.
- Vor
- Completed initial public offering on Nasdaq under ticker symbol
“VOR”.
- Initiated a Phase 1/2a trial of VOR33 in acute myeloid leukemia
(AML).
- Granted Fast Track designation by the FDA for VOR33.
- Entered into collaboration with Janssen Biotech, Inc.
(Janssen), to investigate the combination of Vor’s “invisible” eHSC
transplant platform with one of Janssen’s bi-specific antibodies in
development for AML.
- Follica
- Announced the appointment of two leaders in aesthetic medicine
and dermatology to its Board of Directors, Tom Wiggans, former CEO
of Dermira, and Michael Davin, former CEO of Cynosure.
- Continued to advance regenerative biology platform, including
preparing for a Phase 3 registration program in male androgenetic
alopecia, which is expected to be initiated in 2022.
- Vedanta
- Achieved primary endpoint in Phase 2 clinical trial of VE303,
an orally administered investigational live biotherapeutic product
(LBP) in development for the prevention of recurrent C. difficile
infection (CDI) in high-risk patients.
- Completed a $68 million financing, which included a $25 million
investment from Pfizer as part of the Pfizer Breakthrough Growth
Initiative.
- Sonde
- Launched Sonde Mental Fitness, a voice-enabled mental health
detection and monitoring technology that uses a brief voice journal
entry to evaluate mental well-being, expanding Sonde beyond
respiratory health.
- Announced strategic collaboration with Qualcomm Technologies to
embed Sonde vocal biomarker technology into its latest Snapdragon
mobile chipsets to provide smartphone OEMs with native,
voice-enabled health tracking capabilities.
- Entrega
- Continued advancement of ENT-100 platform for the oral
administration of biologics, vaccines and other drugs that are
otherwise not efficiently absorbed when taken orally.
- Continued collaboration with Eli Lilly to investigate the
application of the Entrega peptide administration technology to
certain Eli Lilly therapeutic candidates.
- References to “Wholly Owned Programs” refer to the Company’s
six therapeutic candidates (LYT-100, LYT-200, LYT-210, LYT-300,
LYT-500 and LYT-503/IMB-150), four lymphatic and inflammation
platforms and potential future therapeutic candidates and platforms
that the Company may develop or obtain. References to “Wholly Owned
Pipeline” refer to LYT-100, LYT-200, LYT-210, LYT-300, LYT-500 and
LYT-503/IMB-150. On July 23, 2021, Imbrium Therapeutics exercised
its option to license LYT-503/IMB-150 pursuant to which it is
responsible for all future development activities and funding for
LYT-503/IMB-150.
- Founded Entities represent companies founded by PureTech in
which PureTech maintains ownership of an equity interest and, in
certain cases, is eligible to receive sublicense income and
royalties on product sales. As of June 30, 2021, PureTech
maintained control over Follica Incorporated, Vedanta Biosciences,
Inc., Sonde Health, Inc. and Entrega, Inc. by virtue of (a)
majority voting control or (b) the right to elect representation to
the entity’s Board of Directors. As of June 30, 2021, PureTech did
not have a controlling interest in Gelesis, Inc., Karuna
Therapeutics, Inc., Akili Interactive Labs, Inc. and Vor Biopharma
Inc.
About PureTech Health PureTech is a clinical-stage
biotherapeutics company dedicated to discovering, developing and
commercializing highly differentiated medicines for devastating
diseases, including inflammatory, fibrotic and immunological
conditions, intractable cancers, lymphatic and gastrointestinal
diseases and neurological and neuropsychological disorders, among
others. The Company has created a broad and deep pipeline through
the expertise of its experienced research and development team and
its extensive network of scientists, clinicians and industry
leaders. This pipeline, which is being advanced both internally and
through PureTech's Founded Entities, is comprised of 25
therapeutics and therapeutic candidates, including two that have
received both U.S. FDA clearance and European marketing
authorization, as of the date of PureTech's most recently filed
Half Year Report and corresponding Form 6-K. All of the underlying
programs and platforms that resulted in this pipeline of
therapeutic candidates were initially identified or discovered and
then advanced by the PureTech team through key validation points
based on the Company's unique insights into the biology of the
brain, immune and gut, or BIG, systems and the interface between
those systems, referred to as the BIG Axis.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Cautionary Note Regarding Forward-Looking Statements This
press release contains statements that are or may be
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements contained
in this press release that do not relate to matters of historical
fact should be considered forward-looking statements, including,
without limitation, those related to our anticipation of catalysts
in 2022 and beyond, the treatment potential of our Wholly Owned
Programs, our expectations around the completion of enrollment and
the timing for results with respect to the Phase 2 and Phase 2a
clinical trials for LYT-100, our plans to provide further detail
around our development plans for LYT-100, our anticipation of
results from the Phase 1 portion our clinical trial for LYT-200,
our expectations related to the potential uses of the results from
the LYT-300 Phase 1 clinical study, the plans to file an
Investigation New Drug Application for LYT-503, our evaluation of
potential therapeutics candidates leveraging the Alivio Technology
Platform, our expectation for data generation and potential
approaches utilizing the Orasome Technology Platform, the treatment
potential of therapeutic candidates of our Founded Entities, our
expectations related to the business combination between Gelesis
and Capstar Special Purpose Acquisition Corp., our expectations
with respect to Karuna’s Phase 3 clinical programs, and our
expectations regarding Follica’s potential commencement of Phase 3
registration program. The forward-looking statements are based on
current expectations and are subject to known and unknown risks,
uncertainties and other important factors that could cause actual
results, performance and achievements to differ materially from
current expectations, including, but not limited to, those risks,
uncertainties and other important factors described under the
caption “Risk Factors” in our Annual Report on Form 20-F for the
year ended December 31, 2020 filed with the SEC and in our other
regulatory filings. These forward-looking statements are based on
assumptions regarding the present and future business strategies of
the Company and the environment in which it will operate in the
future. Each forward-looking statement speaks only as at the date
of this press release. Except as required by law and regulatory
requirements, we disclaim any obligation to update or revise these
forward-looking statements, whether as a result of new information,
future events or otherwise.
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PureTech Public Relations
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EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000
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US Media Nichole Sarkis +1 774 278 8273
nichole@tenbridgecommunications.com
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