BridgeBio's Calcilytix Sees POC For Encaleret And Options To Discuss With FDA

Company Presents Early Phase II Data At ENDO

Calcilytix chief medical officer Jonathan Fox talked to Scrip about the development plans for encaleret for the rare form of hypoparathyroidism.

Yellow road sign with a blue sky and white clouds: clinical trial
BridgeBio presented Phase IIb proof-of-concept data and hopes to meet with the FDA later in 2021 or early 2022. • Source: Shutterstock

BridgeBio Pharma, Inc. appears off to a solid start with its program to develop encaleret for patients with autosomal dominant hypocalcemia type 1 (ADH1), releasing proof-of-concept data showing strong signals of activity and indicating efficacy in the disease.

The trajectory of the COVID-19 pandemic will be a determining factor in how the timing for the next steps of development play out, Calcilytix chief medical officer Jonathan Fox said in an interview with Scrip. Calcilytix is a BridgeBio portfolio company developing the drug with its parent

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from R&D

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By 

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

More from Scrip

Finance Watch: Deerfield Closes $600m-Plus VC Fund; Gates Speeds Up Health Investments

 
• By 

Private Company Edition: Deerfield’s third innovations fund will back therapeutics and other opportunities, the Gates Foundation – a sometimes funder of biotech firms – will spend $200bn over the next 20 years, and NewLimit raised a $130m series B round, among other financings.

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pharma Left Hanging After US/UK Trade Pact

 
• By 

An ‘historic economic prosperity deal’ does not include the sector.