Trinity Delta AT247 Phase I pump data confirms promising profile

AT247 Phase I pump data confirms promising profile

Lighthouse | 11 October 2022

Share this note

Arecor has reported top line data from the US Phase I three-day pump study with AT247, its 100U/ml proprietary ultra-rapid insulin. This double-blind, randomised three-way crossover trial compared the pharmacokinetics (PK)/pharmacodynamics (PD), and safety/tolerability profiles for AT247, NovoLog, and Fiasp delivered by continuous subcutaneous infusion in 24 adult Type I diabetic patients.
The co-primary endpoints for the study were PK (serum insulin at 0-30 minutes) and PD (glucose infusion rate at 0-60 minutes). On the first measure, AT247 demonstrated a superior PK profile, with statistically accelerated insulin absorption and early exposure compared with both NovoLog and Fiasp. The PD profile did not meet the bar of statistically significant superiority; however, a post-hoc analysis controlling for the variable baseline characteristics showed a statistically superior early glucose lowering effect vs NovoLog and a similar PD profile to Fiasp. Full data will be presented at a future international diabetes conference.
These encouraging data, the first from AT247 delivered via a continuous pump, complement the results of the earlier Phase I single injection glucose clamp study. Both studies showed that AT247 has accelerated insulin absorption and a promising glucose lowering effect vs current gold standard rapid-acting and ultra-rapid acting insulins NovoLog and Fiasp, as well as good safety/tolerability profile and flexibility of administration. This growing body of evidence will help inform next steps for the development of AT247, including on its potential for use in a fully closed loop artificial pancreas.
We remind that an ultra-rapid acting insulin will be one of several key components of an artificial pancreas, alongside the device itself and associated algorithms, that will work together to enable better clinical outcomes for diabetics. Importantly, while more extensive studies are warranted, AT247’s superior ultra-rapid acting profile is suggestive of a central role in supporting the development of such a system.

Trinity Delta view: Arecor’s diabetes franchise is a prime example of the strength of the Arestat formulation platform. The confirmation of AT247’s ultra-rapid acting profile supports its further evaluation and development. In parallel, AT278, Arecor’s 500U/ml ultra-concentrated ultra-rapid insulin, will initiate its second Phase I study in H222, which unlike the first, will focus on Type II diabetes. Both in-house diabetes assets are key value drivers for the company, given their highly promising and differentiated profiles which, in our view, could be particularly suited to emerging pump applications and high-dose insulin users. We reiterate that Arecor’s formulation expertise is not limited to diabetes; it has an attractive Speciality Hospital Products pipeline in development and multiple ongoing technology partnerships with pharma. Our valuation is £177m (581p per share)..

Lighthouse

11 October 2022


Price	255p
Market Cap	£77.7m
Primary exchange	AIM London
Sector	Healthcare
Company Code	AREC

Corporate client	Yes

Company description

Arecor Therapeutics is a revenue-generating clinical stage drug developer, with a well-balanced portfolio of in-house and partnered programmes. Its proprietary Arestat formulation platforms result in enhanced products with lower development risks and less onerous regulatory approvals.

Analysts

Lala Gregorek
lgregorek@trinitydelta.org
+44 (0) 20 3637 5043

Philippa Gardner
pgardner@trinitydelta.org
+44 (0) 20 3637 5042

Disclaimer

Trinity Delta Research Limited (“TDRL”; firm reference number: 725161), which trades as Trinity Delta, is an appointed representative of Equity Development Limited (“ED”). The contents of this report, which has been prepared by and is the sole responsibility of TDRL, have been reviewed, but not independently verified, by ED which is authorised and regulated by the FCA, and whose reference number is 185325.

ED is acting for TDRL and not for any other person and will not be responsible for providing the protections provided to clients of TDRL nor for advising any other person in connection with the contents of this report and, except to the extent required by applicable law, including the rules of the FCA, owes no duty of care to any other such person. No reliance may be placed on ED for advice or recommendations with respect to the contents of this report and, to the extent it may do so under applicable law, ED makes no representation or warranty to the persons reading this report with regards to the information contained in it.

In the preparation of this report TDRL has used publicly available sources and taken reasonable efforts to ensure that the facts stated herein are clear, fair and not misleading, but make no guarantee or warranty as to the accuracy or completeness of the information or opinions contained herein, nor to provide updates should fresh information become available or opinions change.

Any person who is not a relevant person under section of Section 21(2) of the Financial Services & Markets Act 2000 of the United Kingdom should not act or rely on this document or any of its contents. Research on its client companies produced by TDRL is normally commissioned and paid for by those companies themselves (‘issuer financed research’) and as such is not deemed to be independent, as defined by the FCA, but is ‘objective’ in that the authors are stating their own opinions. The report should be considered a marketing communication for purposes of the FCA rules. It has not been prepared in accordance with legal requirements designed to promote the independence of investment research and it is not subject to any prohibition on dealing ahead of the dissemination of investment research. TDRL does not hold any positions in any of the companies mentioned in the report, although directors, employees or consultants of TDRL may hold positions in the companies mentioned. TDRL does impose restrictions on personal dealings. TDRL might also provide services to companies mentioned or solicit business from them.

This report is being provided to relevant persons to provide background information about the subject matter of the note. This document does not constitute, nor form part of, and should not be construed as, any offer for sale or purchase of (or solicitation of, or invitation to make any offer to buy or sell) any Securities (which may rise and fall in value). Nor shall it, or any part of it, form the basis of, or be relied on in connection with, any contract or commitment whatsoever. The information that we provide is not intended to be, and should not in any manner whatsoever be, construed as personalised advice. Self-certification by investors can be completed free of charge at www.fisma.org. TDRL, its affiliates, officers, directors and employees, and ED will not be liable for any loss or damage arising from any use of this document, to the maximum extent that the law permits.