– Topline results anticipated in first half of 2020 –
DALLAS–(BUSINESS WIRE)–Peloton Therapeutics, Inc., a clinical-stage biopharmaceutical company
advancing first-in-class oral medicines for cancer and other serious
conditions, announced the completion of patient enrollment in a Phase 2
clinical trial evaluating the efficacy and safety of its lead drug
candidate, PT2977, to treat von Hippel-Lindau (VHL) disease-associated
renal cell carcinoma (RCC). The clinical trial, which has enrolled 61
patients at clinical trial centers in the United States and Europe, is
ongoing and the company anticipates topline results in the first half of
2020.
This open-label Phase 2 trial will evaluate the efficacy and safety of
PT2977 in patients with VHL disease-associated RCC. Key inclusion
criteria are the diagnosis of VHL disease based on a germline VHL
alteration, the presence of at least one measurable solid RCC tumor, and
no evidence of metastatic disease. PT2977 will be administered orally at
a once-daily, 120 mg dose. The primary objective of the trial is to
evaluate safety and efficacy as measured by overall response rate (ORR)
per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST
1.1). Secondary objectives include other measures of efficacy, such as
duration of response and progression free survival. The potential impact
of PT2977 on VHL disease-associated non-RCC tumors, as well as the
tolerability and pharmacokinetics of PT2977, will also be evaluated in
this trial.
Further information on the clinical trial of PT2977 can be found on clinicaltrials.gov
(Study identifier: NCT03401788).
About PT2977
Peloton’s lead drug candidate, PT2977, is a once-daily, oral inhibitor
of hypoxia-inducible factor-2α (HIF-2α). PT2977 has demonstrated
anti-tumor activity with a favorable safety profile in an early-stage
clinical study in patients with solid tumors. The company is initially
focused on developing PT2977 for the treatment of kidney cancer,
specifically metastatic clear cell RCC and VHL disease-associated RCC.
About Von Hippel-Lindau Disease (“VHL Disease”)
VHL disease is a familial cancer syndrome that commonly gives rise to
renal cell tumors. VHL disease affects about one in 36,000 live births,
and it is estimated that there are approximately 20,000 VHL disease
patients in the United States and the European Union. The main
manifestations of VHL disease include RCC as well as retinal, cerebellar
and spinal hemangioblastomas. There are no approved systemic therapies
for VHL disease.
About Peloton Therapeutics
Peloton Therapeutics, Inc. is a clinical-stage biopharmaceutical company
focused on translating novel scientific insights into first-in-class
medicines for patients with cancer and other debilitating or
life-threatening conditions. The company’s lead development program is
evaluating a small-molecule inhibitor of hypoxia-inducible factor-2α
(HIF-2α), a transcription factor implicated in the development and
progression of clear cell renal cell carcinoma and a variety of other
disorders. HIF-2α was previously thought to be intractable using small
molecules.
To learn about Peloton Therapeutics, visit http://www.pelotontherapeutics.com.
Contacts
Alan Musso
Chief Financial Officer
Phone: (972) 629-4070
alan.musso@pelotontx.com
Mike Beyer
Sam Brown Inc.
Phone: (312) 961-2502
mikebeyer@sambrown.com