Longevity investment bulletin: PocDoc, AbbVie, Athersys and more

The latest longevity updates from our investment news desk.

PocDoc adds £2.5m to seed round

Digital health platform PocDoc added £2.5 million to its Seed round, taking total investment raised in the round to £5 million. This extension round was led by existing investors Forward Partners and MMC Ventures, with Simplyhealth Ventures joining alongside angel investors including the founders of Graze and Skin + Me and the owners of McLaren and TAG Heuer.

PocDoc is an app-based technology platform that combines proprietary lateral flow tests and cloud-based AI diagnostics to deliver end to end digital pathways for the assessment, diagnosis and treatment of major diseases. PocDoc is initially focusing initially on cardiovascular disease, where access to full 5 marker cholesterol testing is a major obstacle to diagnosis and treatment.

“We are excited to announce this investment which is a huge statement of confidence from our investors that we have a unique approach to solving a major global problem in healthcare – how to truly increase access and treat people faster, without adding further burden onto clinicians,” said Steve Roest, CEO of PocDoc. “We are thrilled to add Simplyhealth Ventures and look forward to working with them as we look forward to growing in the UK and beyond in the next 12 months.”

No FDA approval for AbbVie Parkinson’s therapy… yet.

Pharma giant AbbVie has received a complete response letter from the US FDA for its New Drug Application for its therapy for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. In its letter, the FDA requested additional information about the device as part of the NDA review.

However, the FDA did not request that AbbVie conduct additional efficacy and safety trials related to the drug, so the company says it “plans to resubmit the NDA as soon as possible.”

“There is an unmet need for people living with advanced Parkinson’s disease as they face daily challenges in managing their condition,” said Thomas Hudson, AbbVie’s chief scientific officer. “We will continue to work closely with the FDA as part of our commitment to bringing this treatment option to people impacted by this disease as quickly as possible.”

Athersys adapts stroke trial endpoints

Cell therapy and regenerative medicine company and Athersys (NASDAQ: ATHX) announced planned amendments to its MASTERS-2 clinical trial protocol following a Type B meeting with the US FDA. The meeting addressed Athersys’ proposed modifications to primary and secondary endpoints for its MultiStem treatment for patients with acute, moderate-to-severe ischemic stroke as well as the evolving standard of care.

Changes include the timing of the primary endpoint assessed by shift analysis in modified Rankin Scale (mRS) score to Day 365 (previously Day 90).

“The proposed changes we submitted to the FDA allow us to thoroughly evaluate the mechanisms through which we hypothesize MultiStem cell treatment can provide benefit to patients suffering an acute ischemic stroke,” said Dr Robert W Mays, head of regenerative medicine at Athersys. “This outcome more accurately reflects our belief that MultiStem’s treatment effect extends beyond Day 90 and is better reflected with a Day 365 assessment of functional recovery.”

Remedium and Exothera team up on gene therapy

Gene therapy company Remedium Bio will collaborate with contract manufacturer Exothera to demonstrate the industrialization potential of Remedium’s lead candidate for osteoarthritis. The company has the only disease modifying gene therapy based on the clinically proven regenerative mechanism of FGF18.

Exothera is a highly experienced viral vector manufacturer, with demonstrated capabilities in large-scale AAV production, achieving state-of-the art titers and quality.

“With several recently approved cell and gene therapy products advancing to the market, gene therapy is transcending the realm of rare monogenic disorders to enable treatment of large unmet clinical needs like Osteoarthritis,” said Frank Luppino, CEO of Remedium. “Remedium’s recently published preclinical results uniquely position the company to advance this transformative therapy to the clinic. We are very excited to be able to partner with Exothera on this project to advance our lead candidate through preclinical toxicology studies and eventually human clinical trials.”

Biophytis targets rare neuromuscular diseases

French biotech Biophytis presented updates on its clinical project for Duchenne’s Muscular Dystrophy (DMD) and its therapeutic potential in rare neuromuscular diseases. The company said it intends to start clinical development in non-ambulatory DMD patients in 2023.

With an Orphan Drug Designation already granted in both US and EU, Biophytis will meet with the FDA in Q2 2023 to discuss and align with the clinical strategy that will support the development in DMD. In addition to DMD, Biophytis has also communicated strong preclinical evidence supporting its activity in Spinal Muscular Atrophy (SMA).

“The participation of Biophytis at the MDA conference is a key event for us, in line with our progress in the field of Rare Diseases and the upcoming initiation of our clinical program MYODA on DMD patients,” said Stanilas Veillet, CEO of Biophytis.

Meet the investor: Sergey Young

Sergey Young is the founding partner of Longevity Vision Fund (LVF), a $100 million venture capital fund investing in growth stages. In this profile piece, he explains that his firm targets therapeutic platforms targeting the underlying causes of aging and broader AI-enabled health tech supporting healthy life extension in general.

“The LVF team aim to be first movers in the field of longevity to help advance life extension innovations and investments at a much bigger scale than before,” says Young. “We have defined a differentiated and de-risked investment strategy that allows us to invest in validated scientific concepts with viable business models and a clear path to FDA approvals, as well as IPOs.”

Mitrix founder on bridging the energy gap

Check out the latest in our series of video interviews with Tom Benson, founder of mitochondrial biotech startup Mitrix Bio. The energy gap created by mitochondrial dysfunction has been implicated in dozens of chronic diseases from Alzheimer’s to CVD and from frailty to immune senescence, and Mitrix is targeting that energy gap with its novel mitlets platform.

“If we find that just increasing energy is all you need, then maybe aging isn’t that complicated,” he says. “Maybe all the other aspects of aging are just secondary symptoms. Maybe if we just provide new mitochondria, that will reverse aging in many, many different parts of the body.”

Biophysical kicks off crowdfunding

Longevity biotech startup Biophysical Therapeutics is now accepting investments by crowdfunding. The company has developed a drug that reduces metabolic heat generation when applied topically to the body, reducing metabolic rate and slowing aging where it is applied. Biophysical believes the compound has antiaging cosmetic potential and its initial focus is cosmetic applications.

“It all adds up – by accepting small amounts of money from a large number of people, we are hoping it will all add up to a significant sum of money, with each person getting part of the company, in proportion to their investment size,” said Dr Michael Forrest, founder and CEO of Biophysical. “Rather than accepting a large amount of money from just a few investors, we are taking a more democratic approach and hoping lots of people join us on our longevity journey.”