Otonomy Provides Update on Clinical Trials and Development Programs
June 15 2020 - 4:05PM
Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today provided an update on its product pipeline and
the timeline to results for the company’s three ongoing clinical
trials, including the Phase 3 trial of OTIVIDEX in Ménière’s
disease. The company will host a conference call and webcast today
at 4:30 p.m. ET to review these updates.
“We have been able to mitigate the impact of the COVID-19
pandemic on our clinical trials by taking steps to ensure the
integrity of data collection from enrolled patients and supporting
the increasing number of sites able to reinitiate recruitment of
new patients,” said David A. Weber, Ph.D., president and CEO of
Otonomy. “While the timing of our trial results has been adjusted
due to the pandemic, what remains the same is that we have clinical
trial catalysts in the coming months for three novel product
candidates that each address significant unmet medical needs in
neurotology for which there are no FDA-approved drug treatments. We
are excited about the transformational opportunity these multiple
readouts provide beginning with the announcement of our Phase 2
tinnitus results next month.”
Otonomy Program Updates
- OTIVIDEX Phase 3 clinical trial in
Ménière’s disease: patient enrollment is ongoing with results
expected in the first quarter of 2021. This trial is being
conducted at approximately 60 trial sites dispersed across
different regions of the United States and multiple countries in
Europe. We believe there is minimal impact of COVID-19 on the
integrity of efficacy data being collected because patients report
their vertigo episodes via a daily telephone diary and compliance
remains high. New patient enrollment was impacted beginning in
March due to quarantine restrictions but we are now seeing renewed
activity across numerous sites in multiple countries. We expect to
complete patient enrollment during the third quarter of 2020 and
announce results in the first quarter of 2021.
- OTO-313 Phase 1/2 clinical trial in tinnitus: results
from exploratory efficacy cohort expected in July 2020. We
have completed enrollment in the exploratory efficacy cohort of
this randomized, double-blind, placebo-controlled trial and are
currently conducting study completion activities. This cohort
enrolled 35 patients with at least moderate tinnitus severity
assessed during a two-week lead-in period using the Tinnitus
Functional Index (TFI), a clinically-validated tinnitus
questionnaire. Patients were randomized 1:1 to a single
intratympanic injection of OTO-313 (sustained exposure formulation
of the NMDA receptor antagonist gacyclidine) or placebo, and
followed for eight weeks. In addition to scoring the severity of
their tinnitus at regular intervals using the TFI, patients also
reported their tinnitus loudness and annoyance using a daily
telephone diary during the follow-up period. While not powered for
statistical significance, we believe this patient number and study
design will be sufficient to assess a clinical signal with OTO-313
treatment and inform next steps for the program. We expect to
announce study results in July.
- OTO-413 Phase 1/2 clinical trial in hearing
loss: patient enrollment is ongoing with results
expected in the fourth quarter of 2020. This is an
ascending single dose safety and exploratory efficacy study for
OTO-413, a sustained exposure formulation of brain-derived
neurotrophic factor (BDNF). We have successfully escalated through
three dose levels totaling 24 patients and recently initiated
enrollment for the high dose cohort. We expect to enroll
approximately 16 patients in this cohort, randomized 3:1 for a
single intratympanic injection of OTO-413 or placebo. Patients
enrolled in this trial have a speech-in-noise hearing deficit
measured at baseline and can have normal up to moderately-severe
hearing loss by conventional testing. Following treatment, patients
undergo repeated testing for safety and exploratory efficacy over 3
months. We expect to announce results from this trial in the fourth
quarter of 2020.
- GJB2 gene therapy program: preclinical
results support selection of product candidate. Otonomy
and Applied Genetic Technologies Corporation (AGTC) are
collaborating to co-develop and co-commercialize an AAV-based gene
therapy to restore hearing in patients with hearing loss caused by
a mutation in the gap junction beta-2 (GJB2) gene -- the most
common cause of congenital hearing loss. Preclinical results
presented at the American Society of Gene & Cell Therapy
(ASGCT) meeting in May 2020 demonstrated that a gene of interest
can be expressed in support cells of the cochlea, which are the
relevant target cells for treating GJB2 deficiency, using novel and
proprietary AAV capsids. Also, consistent gene expression can be
observed in these cells for at least 12 weeks following a single
local administration. These results support the selection of a
product candidate for further development.
- OTO-510: preclinical data presented for novel and
proprietary class of otoprotectant agents. Cisplatin is a
potent chemotherapeutic agent that is widely used to treat a
variety of cancers in adults and children, however, it is commonly
associated with severe adverse effects including cisplatin-induced
hearing loss (CIHL). Otonomy has presented preclinical results
demonstrating varying degrees of otoprotection against CIHL for
several classes of therapeutic agents. In particular, a novel class
of agents that potently binds to cisplatin demonstrated greater
otoprotection than anti-oxidant and anti-apoptotic molecules, and
increased potency relative to other cisplatin-binding molecules
currently in development.
- OTO-6XX: preclinical development
ongoing for regenerative hearing loss program. Otonomy has
demonstrated regeneration of hair cells in a preclinical
proof-of-concept model using a class of small molecules formulated
for sustained-exposure local delivery, and has selected a lead
compound for development. The OTO-6XX program is targeting hair
cell regeneration for the treatment of severe hearing
loss.
- OTIPRIO® Co-Promotion
Agreement completed with ALK-Abelló, Inc. (ALK). Otonomy
recently entered a co-promotion agreement that provides ALK with an
exclusive right to promote OTIPRIO for acute otitis externa (AOE)
to office-based health care professionals in the United States
including ear, nose and throat (ENT) physicians, pediatricians and
primary care physicians. During the multi-year agreement, Otonomy
will receive co-promotion fees and reimbursement of a proportion of
product support costs while also retaining a share of adjusted
gross profits from the sale of OTIPRIO for use in AOE.
- Financial Guidance:
- 2020 Operating Expenses: Otonomy continues to
expect that non-GAAP operating expenses will be in the range of
$35-$38 million, and GAAP operating expenses will be in the range
of $45-$48 million.
- Cash Runway: Otonomy expects that its current
cash, cash equivalents, and short-term investments will be
sufficient to fund company operations to mid-2021, through readouts
for our three ongoing clinical trials.
Webcast and Conference Call
Otonomy management will host a webcast and conference call
regarding these program updates at 4:30 p.m. ET / 1:30 p.m. PT
today. The live call may be accessed by dialing (877) 305-6769 for
domestic callers and (678) 562-4239 for international callers with
conference ID code number: 3655435. A live webcast of the call will
be available online in the investor relations section of Otonomy’s
website at www.otonomy.com and will be archived there for 30
days.
About Otonomy Otonomy is a biopharmaceutical
company dedicated to the development of innovative therapeutics for
neurotology. The company pioneered the application of drug delivery
technology to the ear in order to develop products that achieve
sustained drug exposure from a single local administration. This
approach is covered by a broad patent estate and is being utilized
to develop a pipeline of products addressing important unmet
medical needs including Ménière’s disease, hearing loss, and
tinnitus. For additional information please visit
www.otonomy.com.
Cautionary Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements generally relate to future events
or the future financial or operating performance of Otonomy.
Forward-looking statements in this press release include, but are
not limited to, statements relating to the timing of results,
patient recruitment and activity for, conduct of, and the impact of
COVID-19 on, ongoing clinical trials; the potential benefits and
opportunities of, and activities under the collaboration agreement
between Otonomy and AGTC and the co-promotion agreement between
Otonomy and ALK; expectations regarding preclinical programs,
including development activities; expectations regarding operating
expenses for 2020 and cash runway; and statements by Otonomy’s
president and CEO. Otonomy’s expectations regarding these matters
may not materialize, and actual results in future periods are
subject to risks and uncertainties. Actual results may differ
materially from those indicated by these forward-looking statements
as a result of these risks and uncertainties, including but not
limited to: delays and disruption resulting from
the COVID-19 pandemic and governmental responses to the
pandemic, including current and future impacts to Otonomy’s
operations, the manufacturing of its product candidates, the
progression of its current clinical trials, enrollment in its
current and future clinical trials and patient conduct and
compliance; Otonomy’s ability to accurately forecast financial
results; Otonomy’s ability to obtain additional financing;
Otonomy’s dependence on the regulatory success and advancement of
its product candidates; the uncertainties inherent in the clinical
drug development process, including, without limitation, Otonomy’s
ability to adequately demonstrate the safety and efficacy of its
product candidates, the nonclinical and clinical results for its
product candidates, which may not support further development, and
challenges related to patient enrollment in clinical trials; the
integrity of patient-reported outcomes in its current and future
clinical trials; the risks of the occurrence of any event, change
or other circumstance that could give rise to the termination of
the collaboration agreement between AGTC and Otonomy or the
co-promotion agreement between ALK and Otonomy, or that could
impact Otonomy’s ability to repay or comply with the terms of the
loan provided by Oxford Finance LLC; side effects or adverse events
associated with Otonomy’s product candidates; Otonomy’s ability to
successfully commercialize its product candidates, if approved;
competition in the biopharmaceutical industry; Otonomy’s dependence
on third parties to conduct nonclinical studies and clinical
trials, and for the manufacture of its product candidates;
Otonomy’s ability to protect its intellectual property in the
United States and throughout the world; expectations regarding
potential therapy benefits, market size, opportunity and growth;
Otonomy’s ability to manage operating expenses; implementation of
Otonomy’s business model and strategic plans for its business,
products and technology; general economic and market
conditions; and other risks. Information regarding the
foregoing and additional risks may be found in the section entitled
"Risk Factors" in Otonomy’s Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission (the "SEC") on May 7,
2020, and Otonomy’s future reports to be filed with the SEC. The
forward-looking statements in this press release are based on
information available to Otonomy as of the date hereof. Otonomy
disclaims any obligation to update any forward-looking statements,
except as required by law.
Contacts:
Media InquiriesSpectrum ScienceChloé-Anne RamseyVice
President404.865.3601 cramsey@spectrumscience.com
Investor InquiriesWestwicke ICRRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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