Market Overview

Asana BioSciences Announces Achievement of Positive Results in the Clinical Proof of Concept Study in Atopic Dermatitis with ASN002, A Novel Oral JAK/SYK Inhibitor

Share:

Asana BioSciences, a clinical stage biopharmaceutical company, today
announced that ASN002, its oral once daily dual JAK/SYK inhibitor, has
achieved clinical efficacy in a proof of concept study in patients with
moderate-to-severe atopic dermatitis. In a double blind, placebo
controlled, dose-ranging Phase 1b study conducted at multiple sites in
the USA and Canada, ASN002 met the safety and efficacy endpoints after 4
weeks of treatment and was well tolerated.

"We are very excited about the results of our recently concluded
clinical study with ASN002 in moderate-to-severe atopic dermatitis
patients. ASN002 is the only oral compound in clinical development
targeting JAK (including Tyk2) and SYK signaling, two clinically
validated mechanisms," said Sandeep Gupta, Ph.D., Founder, CEO and
President of Asana BioSciences. "Dysregulation of Th2 and Th22 cytokine
pathways is implicated in the pathogenesis of atopic dermatitis. The
inhibition of JAK and SYK pathways diminishes cytokine production and
signaling including those mediated by Th2 and Th22 cytokines. The
clinical safety and efficacy data to date indicate that ASN002 has the
potential to be an important treatment option in atopic dermatitis as
well as other dermatological and auto-immune diseases," said Dr. Gupta.

ASN002 showed robust clinical efficacy with nearly all patients
obtaining a 50% improvement in disease severity (EASI50) at 40mg and
80mg once daily and substantial decreases in patient-reported itch
measured by Numeric Rating Scale (NRS) after 4 weeks of treatment. More
subjects treated with ASN002 achieved an improvement to 0-1 in their
Investigator's Global Assessment (IGA) relative to subjects who received
placebo. Improvements with ASN002 were also observed in a reduction of
body surface area (BSA) of skin involvement. ASN002 showed
dose-dependent exposure in patients and caused reductions in several
serum inflammation biomarkers including cytokines.

Dr. Emma Gutman-Yassky, the Sol and Clara Kest Professor of Dermatology,
Vice Chair, Department of Dermatology, and Director of the Eczema Center
and Laboratory for Inflammatory Skin Diseases at the Icahn School of
Medicine at the Mount Sinai Medical Center in NY stated, "We currently
do not have safe oral treatments for treating our moderate-to-severe AD
patients, and available immune suppressants harbor many side effects. It
is exciting to have a novel oral therapeutic option such as ASN002 that
can achieve rapid disease control in patients with moderate-to-severe AD
and also seems to be well tolerated. Larger and longer studies are
needed to show long-term disease control and safety over time, but this
is very exciting news so far."

In the current Phase 1b study, the safety and tolerability profile of
ASN002 at all dose levels was excellent. The most common adverse event
(AE) observed was transient, mild headache, mostly restricted to Day 1.
There were no clinically significant laboratory changes including
hematological parameters observed in this study.

The detailed efficacy and safety results of this study will be presented
in scientific conferences in the near future. Asana will be initiating a
Phase 2b study of ASN002 in moderate-to-severe atopic dermatitis
patients in the early part of 2018. Clinical studies in other
dermatological and autoimmune indications are under evaluation.

About Asana BioSciences, LLC

Asana BioSciences, is a research and development company based near
Princeton, NJ, specializing in the discovery and development of new
chemical and biological entities. Multiple assets from Asana's portfolio
are currently in clinical development in a variety of therapeutic areas,
including oncology, dermatology and autoimmune diseases. Asana is an
independent member of the AE Companies, Bridgewater, NJ.

Asana's lead molecule ASN002 is an investigational product, its
efficacy and safety has not been fully established and is not approved
by the FDA or other regulatory authorities. ASN002 is also
currently being evaluated in a Phase I/II clinical study in patients
with non-Hodgkin lymphomas (NHL), peripheral T-cell lymphoma (PTCL),
chronic lymphocytic leukemia (CLL) and myelofibrosis (MF), with early
evidence of clinical activity and good tolerability (NCT02440685).

ASN003, a selective inhibitor of BRAF and PI3 Kinase, is
currently in Phase I development in patients with advanced solid tumors (NCT02961283).
The RAS-RAF-MEK and PI3K pathways are frequently mutated in melanoma and
other cancers, such as colon and lung cancer. Dual targeting of RAF and
PI3K pathways with ASN003 has the potential to overcome and/or delay
acquired resistance to selective RAF inhibitors and improved efficacy
against cancers driven by both pathways. To date, the drug is well
tolerated in patients and shows pharmacodynamic activity. Enrollment is
ongoing in patients with BRAFV600 mutated metastatic
melanoma, metastatic colorectal cancer (CRC), or advanced non-small cell
lung cancer (NSCLC), and advanced solid tumors with documented PIK3CA
mutation.

ASN007 is a potent inhibitor of the
extracellular-signal-regulated kinases, ERK1 and ERK2 (ERK1/2), key
players in the RAS/RAF/MEK/ERK (MAPK) signaling pathway. This pathway is
frequently hyper-activated in a wide range of cancers. ASN007 shows
potent anti-proliferative activity in cancer lines that are selectively
driven by the MAPK-pathway, including RAS mutant cell lines.
Furthermore, ASN007 demonstrates strong inhibition of tumor growth in
multiple BRAF and KRAS mutant patient-derived and cell line-derived
xenograft models, including those that are resistant to BRAF and MEK
inhibitors. ASN007 is being evaluated in a Phase 1 study in patients
with advanced solid tumors, including BRAF and KRAS mutant cancers.

ASN004 is an Antibody Drug Conjugate (ADC) that targets the 5T4
oncofetal antigen that is expressed in a wide range of malignant tumors,
while very limited expression is found in normal tissues. ASN004
demonstrates robust antitumor activity leading to complete tumor
regressions in multiple human tumor xenograft models with no development
of resistance to ASN004 treatment. The IND-enabling program for ASN004
has been completed and a First-in-Human Phase 1 trial is being planned
in 2018.

ASN008 is a topical formulation of a novel Na+-channel
blocker being developed for the treatment of chronic itch conditions and
pain. In animal models of itch, ASN008 showed dose-dependent, rapid
onset and long duration of action after a single application. The
IND-enabling program has been initiated and a Phase 1 study is being
planned.

www.asanabiosciences.com

View Comments and Join the Discussion!