CRINETICS PHARMACEUTICALS, INC. Item 8.01 Other Events.
On
During his presentation,
2020 Accomplishments
• Paltusotine for Acromegaly: In the fourth quarter of 2020, Crinetics
reported positive top-line data from its Phase 2 program evaluating
paltusotine for the treatment of acromegaly. These results demonstrated that
individuals with acromegaly who switched from standard-of-care injected
somatostatin receptor ligand (SRL) depots to once-daily oral paltusotine
were able to maintain the level of insulin-like growth factor-1 (IGF-1) that
was previously achieved on standard-of-care.
• Pipeline Programs Advanced Toward the Clinic: Crinetics selected CRN04894 as
the company's lead ACTH antagonist and completed first-in-human-enabling
manufacturing and toxicology studies. Such studies were also completed for
its somatostatin receptor type 5 (SST5) agonist (CRN04777) drug candidate.
After review of preclinical and manufacturing data, as well as Phase 1 study
designs, the U.S. Investigational New Drug (IND) application for CRN04894 is
now open and Germany's Federal Institute for Drugs and Medical Devices
(BfArM) has approved the start of the Phase 1 trial for CRN04777.
• In-house Expertise: Throughout 2020, Crinetics bolstered its clinical and
medical teams with the addition of experts in the development of
therapeutics and management of clinical trials for endocrine diseases. These
new hires include Drs. Alessandra Casagrande , Peter Trainer and Hjalmar
Lagast , who join Drs. Alan Krasner and Christine Ferrara-Cook .
2021 Goals
• Paltusotine for Acromegaly: Crinetics expects to hold an end-of-Phase-2
meeting with the FDA in the first quarter of 2021 and start its Phase 3
program in the first half of 2021. Crinetics intends to use a new, improved
tablet formulation of paltusotine in the Phase 3 program for acromegaly.
This formulation is designed to provide convenient once-daily administration
but enable a reduced fasting requirement (0.5 to 1 hour before eating) and
improved dose-proportional exposure compared to the prior formulation. In
addition, the new tablet formulation is designed to enable the
administration of paltusotine with commonly used proton pump inhibitors.
• Paltusotine for Carcinoid Syndrome: Crinetics expects to advance paltusotine
into a clinical study in patients with carcinoid syndrome due to
neuroendocrine tumors (NETs). Injected SRLs are the standard of care for
patients with carcinoid syndrome, but many patients become increasingly
resistant to treatment over time, requiring increased dosage of depot
preparations or the addition of short-acting analogs. Crinetics believes
that an oral therapy with a long half-life and dose-proportional exposure
would be a useful option for these patients, if approved.
• CRN04894: A Phase 1 study evaluating the ability of CRN04894 to suppress
ACTH-stimulated cortisol secretion in healthy volunteers is planned to
commence in January 2021 . Data is expected in the first half of 2021 and, if
positive, the results from this trial may provide proof-of-concept data
supporting further evaluation of CRN04894 in the treatment of diseases
associated with excess ACTH such as Cushing's disease and congenital adrenal
hyperplasia (CAH). CRN04894 is an investigational, oral, selective ACTH
antagonist designed to block the action of excess ACTH on the adrenal gland
resulting in excess cortisol in Cushing's disease and excess adrenal
androgens in CAH.
• CRN04777: A Phase 1 study evaluating the ability of CRN04777 to reduce
stimulated insulin secretion in healthy volunteers is planned to commence in
February 2021 . Data is expected in mid-2021 and, if positive, the results of
this trial may provide proof-of-concept data to support further evaluation
of CRN04777 in the treatment of children with CHI. CRN04777 is an
investigational, oral, selective non-peptide SST5 receptor agonist designed
to reduce insulin secretion and thereby correct the life-threatening
hypoglycemia (low blood glucose) that affects these children.
• In 2021, Crinetics expects to continue its drug discovery efforts with
programs to identify drug candidates for hyperparathyroidism, nonfunctional
pituitary adenomas and polycystic kidney disease, among other indications.
This pipeline expansion is intended to drive continued growth and value for
stakeholders.
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Forward-Looking Statements
Crinetics cautions you that statements contained in this press release regarding
matters that are not historical facts are forward-looking statements. These
statements are based on the company's current beliefs and expectations. Such
forward-looking statements include, but are not limited to, statements
regarding: the potential benefits of paltusotine for acromegaly patients and for
patients with carcinoid syndrome; the potential to initiate a Phase 3 program of
paltusotine in acromegaly and the expected timing thereof; Crinetics' plans to
meet with the FDA in the first quarter of 2021; the benefits of Crinetics'
improved tablet formulation of paltusotine; the potential to initiate a of
paltusotine in patients with carcinoid syndrome due to NETs and the expected
timing thereof; the potential to begin Phase 1 clinical development with
CRN04894 and CRN04777 and the expected timing for the commencement thereof and
the related generation of proof-of-concept data in healthy volunteers;
Crinetics' plan to advance its programs into late-stage clinical trials and to
create new drug candidates for additional diseases; and Crinetics' plans to
identify and create new drug candidates for additional diseases, including
hyperparathyroidism, nonfunctional pituitary adenomas and polycystic kidney
disease, among other indications. The inclusion of forward-looking statements
should not be regarded as a representation by Crinetics that any of its plans
will be achieved. Actual results may differ from those set forth in this press
release due to the risks and uncertainties inherent in Crinetics' business,
including, without limitation: advancement of paltusotine into a Phase 3 program
for acromegaly or a trial for carcinoid syndrome and CRN04894 and CRN04777 into
Phase 1 trials are dependent on and subject to the receipt of further feedback
from the FDA; the COVID-19 pandemic may disrupt Crinetics' business and that of
the third parties on which it depends, including delaying or otherwise
disrupting its clinical trials and preclinical studies, manufacturing and supply
chain, or impairing employee productivity; the company's dependence on third
parties in connection with product manufacturing, research and preclinical and
clinical testing; the success of Crinetics' clinical trials and nonclinical
studies for paltusotine, CRN04894, CRN04777 and its other product candidates;
regulatory developments in
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