SAN DIEGO, Dec. 14, 2021 /PRNewswire/ -- Denovo
Biopharma LLC ("Denovo"), a pioneer in applying precision medicine
to the development of innovative therapies, today announced its
partner Aytu BioPharma (Nasdaq: AYTU), has received FDA
clearance for its IND application for enzastaurin and also Orphan
Drug Designation (ODD) for enzastaurin for
the treatment of Vascular Ehlers-Danlos Syndrome (VEDS).
The IND clearance enables Aytu to proceed with initiating a
pivotal clinical trial for enzastaurin in VEDS. Aytu plans to
initiate the PREVEnt Trial in VEDS in the first half of 2022. The
PREVEnt Trial will assess the safety and efficacy of enzastaurin in
COL3A1-confirmed VEDS patients.
The FDA grants ODD status to drugs and biologics that are
intended for the safe and effective treatment, diagnosis or
prevention of rare diseases, or conditions that affect fewer than
200,000 people in the U.S. ODD affords certain financial incentives
to support clinical development and the potential for up to seven
years of market exclusivity in the U.S. upon regulatory approval.
In addition to this ODD for enzastaurin for VEDS, it has ODD for
DLBCL and glioblastoma multiforme (GBM) from the FDA and EMA.
"Since licensing enzastaurin for VEDS from Denovo earlier this
year, Aytu has made remarkable progress with enzastaurin for
patients with VEDS," said Michael F.
Haller, PhD, Denovo's Chief Business Officer. "This
demonstrates the value of Denovo's strategy of acquiring drugs
and developing them itself with novel biomarkers in parallel with
licensing non-core indications for partners to develop for
the potential benefit of patients, the partner, and Denovo."
About vascular Ehlers-Danlos Syndrome (VEDS)
Vascular Ehlers Danlos Syndrome (VEDS) is the severe subtype of
Ehlers-Danlos Syndrome, affecting 1 in 50,000 people worldwide and
results from pathogenic variants in the COL3A1 gene, which encodes
the chains of type III procollagen, a major protein in vessel walls
and hollow organs. VEDS is typically diagnosed in childhood and is
characterized by arterial aneurysm, dissection and rupture, bowel
rupture and rupture of the gravid uterus. Twenty-five percent of
VEDS patients have a first complication by the age of 20 years, and
more than eighty percent have at least one complication by the age
of 40. VEDS is a devastating condition, and VEDS patients have a
median lifespan of 51 years. There are no FDA-approved therapies
for VEDS.
About Denovo Biopharma
Denovo Biopharma LLC is a clinical-stage biopharmaceutical
company that uses novel biomarker approaches to re-evaluate
medicines that have failed in broad patient populations. The
company seeks to discover genomic biomarkers correlated with
patients' responses to drug candidates retrospectively. Denovo then
designs and executes efficient clinical trials in targeted patient
populations to optimize the probability of a successful trial.
Denovo has completed enrollment of patients with diffuse large
B-cell lymphoma (DLBCL) in a Phase 3 clinical trial in the US
and China, and enrollment is
ongoing in a Phase 3 trial in GBM for its lead product
candidate, DB102 (enzastaurin), which was in-licensed from Eli
Lilly & Co. The company has seven additional late-stage
programs targeting major unmet medical needs: DB103 (pomaglumetad
methionil) for schizophrenia, DB104 (liafensine) for depression,
DB105 (ORM–12741) for Alzheimer's Disease, DB106 (vosaroxin) for
acute myeloid leukemia (AML), DB107 (Toca 511/Toca FC)
for recurrent high-grade GBM, DB108 (endostatin) for non-small cell
lung cancer (NSCLC), and DB109 (idalopirdine) for Alzheimer's
Disease. For additional information please visit
www.denovobiopharma.com.
Contact:
Michael F. Haller, Chief Business
Officer
Denovo Biopharma LLC
mhaller@denovobiopharma.com
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SOURCE Denovo Biopharma LLC