Underdog Pharmaceuticals, Inc., a pharmaceutical company designing engineered cyclodextrins to address atherosclerosis and other serious diseases of aging, has concluded a successful meeting with the Medicines and Health products Regulatory Agency (MHRA) of the UK. The goals of the meeting were to set standards for Phase 1, lay the groundwork for endpoints demonstrating real disease modification, and determine whether Underdog may be able to enroll asymptomatic patients in the Phase 1 trial.
Underdog received acknowledgement of being on course with its plans for in vivo efficacy and safety testing. Underdog’s program for the development of drug product for the clinical trial raised no significant concerns.
The MHRA supported inclusion of trial participants with asymptomatic, stable, “non-culprit” plaques, as long as subjects have no diagnosed CVD condition. Since Underdog may be allowed to perform multiple, minimally invasive plaque and 7-ketocholesterol (7KC) biomarker measurements, enrollment of asymptomatic subjects presents an opportunity for Underdog to obtain information about the characteristics of the plaque and 7KC burdens in these patients. This is a unique opportunity to acquire valuable human data on target engagement and clinical proof of concept early during the Phase I trial.
Additionally, Underdog was invited to submit an ILAP (the Innovative Licensing and Access Pathway) application. ILAP is a new, exclusive program of the MHRA, National Institute for Clinical Excellence, and National Institute for Health Research resources, and provides advantages similar to the FDA’s accelerated programs, and may allow reimbursement for clinical trials through the NHS. Underdog has submitted its application and has already been granted a review meeting.
With the aim of entering the clinic as soon as reasonable, Underdog has commenced its campaign for Series A funding. Seeking a minimum of $9M, the company will utilize the funding to complete IND enabling studies and the IND filing. Underdog’s current lead investor, Kizoo Technology Ventures, has committed to co-leading the round. “We are honored to have such strong support from our seed-stage investors and are excited to bring on a select few, new, strategic investors. Their confidence in us has us well positioned for continued development of our pipeline and supports our ambition in addressing all diseases caused by plaque formation, an opportunity to save countless lives,” said Mike Kope, co-CEO of Underdog.
About Underdog
Underdog Pharmaceuticals, Inc., uses engineered cyclodextrins to address atherosclerosis and other serious diseases of aging. The development of arterial plaques, or atherosclerosis, drives many diseases including stroke, COPD, and heart disease. It is the #1 killer in the world.
Underdog’s robust computational chemistry and synthetic chemistry programs were born in the labs of SENS Research Foundation (SRF), the only non‐profit devoted to reversing age‐related disease by addressing their underlying causes. The company’s novel molecules attack the core cause of atherosclerosis: the oxidized cholesterol derivatives that inhibit the cardiovascular self-repair system. Underdog can target these derivatives safely and effectively, without interfering with key enzymatic systems; offering the possibility of a new class of drugs that could reverse, not merely treat, this deadly disease. Underdog’s founders, Matthew O’Connor and Michael Kope, were principals of SRF and advocates of genuine rejuvenation biotechnologies. Advisors include world-renowned biomedical gerontologist Aubrey de Grey, leading cyclodextrin expert Lajos Szente, and atherosclerosis expert Professor W. Gray “Jay” Jerome.
About Kizoo Technology Ventures
Kizoo provides mentoring and seed and early-stage financing with a focus on rejuvenation biotechnology. Having been entrepreneurs, VCs, and mentors in both high-growth tech and biotech companies for many years, with multiple exits and massive value created for the founders, Kizoo now brings this experience to the emerging field of rejuvenation biotech – a young industry that will eventually become much bigger than today’s largest technology markets.
As part of the Forever Healthy Group, Kizoo directly supports the creation of startups turning research on the root causes of aging into therapies and services for human application. Investments include AgeX, FoxBio, Turn.bio, Elevian, Oisin Biotechnologies, LIfT BioSiences, MAIA Biotechnology, and others. Forever Healthy’s other initiatives include the evaluation of new rejuvenation therapies, evidence-based curation of the world’s cutting-edge medical knowledge, funding research projects on the root causes of aging, and hosting the annual Undoing Aging Conference. For more information, please visit: kizoo.com and forever-healthy.org.
Notice:
This notice and the information presented herein are for informational purposes and are not an offer to sell or a solicitation of an offer to buy any securities in any company and may not be relied upon in connection with the purchase or sale of any security.
Media contact:
For Underdog: press@cyclaritytx.com
